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In the United Kingdom (UK) the number of children diagnosed with paediatric cancers every year has increased by 29% since the late 1970’s, this means research into paediatric friendly treatments are more important than ever as the number of children who experience these continues to grow (Cancer Research UK, 2013). The long-term effects of paediatric cancer are at the forefront of current research as 82% of all children in the UK that have had a cancer diagnosis survive for 5 years or more, with the majority of them having been cured (National Cancer Intelligence Network, 2013). There has been research into the psychological heath and cognitive development of survivors later in life. This research shows that childhood cancer survivors are academically disadvantaged when compared to others of the same age post treatment (canning et al, 2014).
This proposal is intended to examine the use of Mind-Body Therapies (MBTs) during and alongside the treatment as a way to possibly improve the long-term outcomes. MBT’s consist of a number of techniques, including tai chi, yoga and meditation, all of which concentrate on the interactions between the brain and the body to promote relaxation of both mind and body (National Center for Complimentary and Integrative Health, 2016). This enhances the mind’s capacity to affect bodily functions and symptoms prompting its own cure (Kanitz et al, 2013). The therapy that this research will focus solely on is hypnosis as the previously mentioned MBT’s are either active and involve movement, making it inappropriate for use in radiotherapy. Hypnosis can be described as a trancelike state that resembles sleep and is induced by a person whose suggestions are readily accepted by the subject (Merriam-Webster, 2017).
The use of hypnosis is the most frequently cited form of relaxation of non pharmacological intervention in pain control, it has also been employed for the relief of nausea and vomiting secondary to chemotherapy (Kanitz et al, 2013). Muscle relaxation is a side effect of hypnosis, which can be seen as an additional postitve alongside the hypnosis itself. This is due to the need for the child to lay still throughout their radiotherapy treatment in order to ensure it is accurate as there is no room for error. Hypnosis has previously been proposed for use in the preparation for medical procedures outside of oncology, including those done under general aneasthetic and for incorporation into the management of anticipatory anxiety and distress, making it ideal for radiotherapy patients as both are issues in pediatric oncology. Children are more easily hypnotized than adults, responding to the general development needs of the child, it uses their ability to create fantasy through their own imaginations, which become less vivid as people age (Huynh et al, 2008).
Hypnotherapy has previously been viewed by the public as a hoax, this may be due to the fact that there are currently no laws within the UK to indicate the level of education required in order to practice professionally (Hypnotherapy Directory, 2017). However to work within a medical professional setting does require registeration with a governing body, this requires specific requirements of a strict standard thus ensuring that the hypnotherapists involved with this piece of research will meet a stringent criteria.
The question proposed for this piece of research would be; A study into the use of Hypnosis to reduce the long-term psychological and cognitive effects of paediatric radiotherapy. This proposal will outline the type of hypnosis in question, suggested methodology, and ethical arguments.
The aim of this research would be:
- to focus the benefits of hypnosis on pediatric radiotherapy in order to reduce pre-treatment anxiety and the need for aneasthetic.
- help with the long-term cognitive and psychological effects, thus giving more postitive results at the 5-year survivorship assessment.
- prove that hypnosis should be recommended in best-practice guidelines for paediatric radiotherapy, in order to reduce psychological and cognitive effects later in life, thus giving a better quality of life post-cancer.
2.0 Critical Review of Literature Discussion
2.1 Search strategy
The aim of this search was to achieve a good breadth of relevant literature for the purpose of substantiating the hypothesis that hypnosis can be used alongside paediatric radiotherapy in order to reduce the psychological and cognitive effect that appears later in life.
The origional literature search took place using Google Scholar, however this was just a basic overview of the intended topic and to see if any research into the topic has been previously attempted. The main search took place using the medical database PubMed which incompases MEDLINE, the National Library of Medicine, this was chosen as the articles here are peer reviewed making any results more creditable. This is supported by guidance from Smith and Bird (2010) that recommends using sources critiqued by experts in the relevant field as it lends more weight to the study’s findings. It must be noted that this database is American based, this can have an impact on the search terms with regards to the spelling and terms (De Brun & Pearce-Smith, 2009).
The words and phrases deemed key in the various searches included; paediatric, radiotherapy, psychological, hypnosis/hypnotherapy, cognitive, oncology, and long-term/survivors. All of the literature searches included at least one of these words, and were entered in various orders and combined with other searches. Originally there was a date limitation (2006 to current day) on the searches in order to try and find recent research. The reason these particular dates were chosen is due to referencing restriction. Anything prior to this date would not be an ideal reference due to how fast radiotherapy has advanced and improved. However, these restrictions were eventually removed due to the lack of current papers. The papers found outside of the date limitations will be used in this literature review as some of their information is still relevant today.
See appendix 1 for a breakdown of how literature was found.
2.2 Aneasthetic in Paediatric radiotherapy
Evans and Chisholm (2008) looks into the use of anaesthesia during paediatric oncology appointments and its need related to each potential treatment and procedure. It highlights any potential issues with regards to patient positioning within radiotherapy and the physical limitations of the immobolisation equipment; a genuine concern which must be considered by the radiographers during the creation of any personal immobolization. This paper talks mostly about the breakdown of the different forms of anaesthesia used within the radiotherapy setting and talks only briefly about the side effects and potential dangers whilst unconcious. Within the conclusion of this paper it remarks that the anaesthetic technique must be safe and aim to have minimal impact on the child’s life, however, the author does not look into or comment on the effects it has on the childs life anywhere within the text.
The goal of radiotherapy is to deliver a high dose of irradiation to the specified treatment area whilst sparing as much healthy tissue as possible. This causes issues with younger children as patient mobility can cause the treatment to be inaccurate, therefore, general anaesthtic is normally used for those under 5 years of age but can be administered to older children who have learning difficulties or behavioural problems (Williams & Conroy, 1998). Although this paper can be seen as out of date it talks extensively of the unique anaesthetic considerations when anaesthetic must be administered frequently (in the case of radiotherapy this is daily, at least 5 times a week for a number of weeks), these still apply today and is backed up by The Royal College of Radiologists, Society and College of Radiographers, and Children’s Cancer and Leukaemia Group (2012). Aneasthetic is usually administered intravenously due to the rapid on-set and awakening.This involves the insertion of a long-term device such as a Portacath or Hickman line which is an additional painful procedure that the child must go through.
Although, whilst under aneasthesia the child is watched by a team of aneasthetists outside the room throughout treatment to ensure that the breathing and heartrate remain stable, the potential for serious deterioration under anaesthesia is very real (Evans & Chisholm, 2008). Some of the possible complications includes, hypoxia (deficiency in the amount of oxygen reaching the tissues), Prolonged sedation, apnea (suspension in breathing), vomiting, and the need for assisted ventilation (Alexander, 2012). As well as the danger of being under anaesthetic recent studies have shown that children who are exposed to anaesthetic under the age of 4 to develop learning disabilities, problems with language comprehension, and decreased gray matter density which is linked to reduced muscular activity (Backeljauw, et al., 2015:Ing, et al., 2012)
These impediments bring to light the need for a way in which to reduce the use of aneasthesia, whether this be by using a method of relaxation or finding a non-medicinal route such as hypnosis. Although most specialist childrens hospitals will have the input from Play Specialists which can help reduce the need for anaesthesia through preparation and distraction techniques, it is possible to incorporate hypnosis into these techniques thus further reducing the number of children undergoing gerneral anaesthetic.
2.3 Psychological effect
Childhood cancer presents unique and significant challenges psychologically due to the following factors; isolation from peers, challenges regarding self-image and self-esteem, and reduced autonomy and independence. These psychological factors also have the potential to impact upon emotional distress (Canning et al, 2014).
Throughout cancer treatment a patient undergoes numerous painful procedures, from venipuncture (the puncturing of a vein usually in order to take blood or inject a substance) to biopsies (the removal of tissue in order to examine or test). When examined in combination with the cancer diagnosis itself and the psychological impact of it, studies believe this puts patients at risk of long-term psychological distress (Liossi, 2003). One of the most recognized psychological issues is ‘childhood depression and anxiety’. Evaluation and treatment of this is important given the potential outcomes previously outlined above (Kersun & Elia, 2007). The assessment of this in children with chronic illness in their past is particularly difficult, determining whether the symptoms are secondary to the illness and treatment or a manifestation of psychological difficulty (Kersun & Elia, 2007).
The term ‘late effects’ refers specifically to the unrecognized toxicities that are absent or subclinical at the end of therapy but infact manifests at a later date due to growth, development, or aging (Schwartz, 1999). These are of particular worry when treating children, this is because the probability of developing these issues increases due to the exposure to radiation so early in life. This paper looks at the long-term effects of cancer treatments on each part of the paediatric body highlighting the need to mitigate the effects when possible and, if not possible, to understand them so as to help future treatments be designed with fewer long-term risks.
2.4 Cognitive effect
The continuously developing brain of a child is highly sensitive when it is compared to the full grown adult brain (Verheyde & Benotmane, 2007). Although radiotherapy damages the brain regardless of age, the immature brain is susceptible to treatment-related pathological changes putting young people at risk of significant, long-term neuropsychological sequelae (Macartney et al, 2014).
Clinical experiences suggest that brain tissue injury becomes increasingly apparent in the years that follow therapy completion. Over time intellectual growth starts to lag behind the expected course. These cognitive effects are actually quite common, resulting in poor academic achievment, such as; difficulty in reading, language, and arithmatic. These may arise from the impairment of attention capabilities, memory and visual perceptual motor skills (Schwartz, 1999; Patenaude & Kupst, 2005). There is already a link between cancer treatment and increased risk of neurocognitive late effects, particularly the cognitive abilities underlyinging successful mathematic abilities, warranting further investigations into interventions targeting specific academic abilities (Canning et al, 2014).
Oeffinger & Hudson ( 2004) discuss the statistics of cognitive dysfunction of long-term survivors of pediatric and adolescent cancer. Deficits in full-scale intelligence quocient, verbal intelligence (IQ), visual-spatial abilities, attention-concentration, non-verbal memory, and somatosensory functioning were reported, all with numerical data to support the claims making it a reliable study on which to base further research (Oeffinger & Hudson, 2004). This is a significant paper which demonstrates the excessive need for change within paediatric radiotherapy.
Hypnosis is an altered state of conciousness that intentionally uses suggestion to affect changes in a person’s “sensation, perception and physiology”. It is shown to be an effective agent in stress-minimizing strategy for pediatric patients in various medical settings such as emergency medicine, radiology, wound care, and intravenous catheterization (Alexander, 2012). The paper by Alexander (2012) addresses a number of stress-minimizing stategies for children with regards to painful procedures, and concludes all of them to be successful. However, it also admits that further research needs to be done.
Complementary and alternative medicine (CAM) therapies, such as; relaxation techniques, guided therapy, and hypnosis are achiving considerable increase in popularity and recognition in adults (Saadat & Kain, 2007). Children in general are more hypnotizable than adults, therefore the abundant empirical literature indicating the utility of hypnosis for a wide range of adult problems should be equally, if not more, potent when used with children (Gold et al, 2007). Saadat & Kain (2007) also discuss the reasons as to why a child is more suceptible to hypnosis than an adult. They believe this is attributed to the enhanced ability to immerse oneself in fantasy, play and immagination; this ability means that the suggestions that are made during the hypnotic process are more openly accepted creating a surreal imaginary world that they are able to submerse themselves in. This paper also discusses the primary aims of hypnosis during a distressing or painful procedure; capturing the child’s attention, reducing distress, ‘reframing’ their pain experiences, and helping dissociate themselves from the pain. These must be a focus throughout the duration of the research.
Hypnosis actually corresponds to a state of inner absorption and such a focused attention that the individual becomes unconcerned about any other consideration. It is based on the principle of dissociation, with a concentrated but focused attention which is different from sleep (Lucas-Polomeni, 2004). Within the radiotherapy department this would mean the child would be focused on a story in a dream-like way, thus not acknowledging the treatment machine or immobolisation equipment, not only allowing them to remain still but to be free from the stress and anxiety that is associated with hospitals and treatment. This means that hypnosis can not only be used for young children but for those who may not require general anaesthetic yet are still at risk of developing long-term psychological and cognitive effects. However, hypnosis does require a certain degree of concentration, this means that children who are under the age of three may not necessarily be able to maintain a state of hypnosis due to their short attention spans.
Hypnosis has been used successfully in pediatric radiotherapy once before in American during 1999, however, the study was only conducted in 3 cases as an alternative to general anaesthetic. Bertoni et al (1999) talk in depth about how a hypnotic state was reached and continued throughout treatment. However, they concluded that is should be reserved for particularly difficult cases as further research was needed.
Liossi (2009) talks about the fact that despite there being evidence for the efficiency of hypnosis, it’s widespread use has been prevented due to the number of estimated sessions needed in order to master the hypnotic skills. However, during the study Liossi (2009) successfully managed to teach hypnosis to the children in a single, short 15 minute session thereby challenging the prevailing belief. The time arguement is not an issue in radiotherapy due to the fact that treatment must be precisely planned for each individual patient, this allows a time frame in which appointments can be made with the hypnotherapists in order to introduce the child to the procedure of hypnosis, learning their likes and dislikes in order to personalize the hypnosis to each individual child and perfect the technique.
Anaesthetic has multiple research papers linking even a single exposure to multiple kinds of developemental cognitive side effects, as well as the immediate dangers whilst under general anaesthetic, and yet there has not been a proposed alternative. Although not all children who undergo radiotherapy are anaesthatized paediatric radiotherapy itself also causes long-term effects in children. It can be linked to both; undergoing general anaesthetic in young children and to the previously discussed psychological triggers and distress in older children.
Hypnosis has the potential to be the non-medical alternative of this within cancer care, having previously been found effective during a small radiotherapy case study in The United States of America as well as in other aspects of care including pain relief. Due to the huge percentage of children who exceed 5-year survival post cancer the long-term effects of radiotherapy must be prioritized as the number of diagnoses each year continues to increase.
In conclusion this research will fill a large gap in pediatric oncology literature regarding radiotherapy. The literature available that has been reviewed proves the need for something to be put in place in order to minimise the cognitive and psychological effects of pediatric treatment; and papers available about oncology hypnosis show that it can be transferred and adapted to radiotherapy.
3.1 Experimental design
Observational studies are an important category of study designs. In order to address some research questions in paediatric radiotherapy, randomized controlled trials are not always indicated or ethical to conduct. Observational studies may be the next best method to address these types of questions. Well-designed observational studies have been shown to provide results similar to randomized controlled trials (Song & Chung, 2010). In paediatric psycho-oncology, as in the rest of psychological and medical research, there is an increasing interest in evidence-based practice and in randomized clinical trials (Stinson et al, 2003). However, controls are difficult to select for paediatric cancer studies. This is because there are no clearly comparable life experiences; even comparisons to other chronic diseases is not ideal. When compairing with healthy children the use of siblings as controls has been known. However, this is questionable as previous research shows that a brother or sister’s experience with cancer can be influential (Alderfer & Hodges, 2010; Sahler et al, 1994).
Cohort studies and case-control studies are two primary types of observational studies that aid in evaluating associations between diseases and exposures. A well-designed cohort study can provide powerful results. In a cohort study, an outcome study population is first identified by the event of interest (in this case Psycho-cognitive effects of pediatric radiotherapy) and followed in time until the outcome of interest occurs (Song & Chung, 2010). Robison (2003) writes, “While cohort studies represent a strong study design for many topics of late effects research, there are other designs, such as case-control, case-case, and cross-sectional studies, that can be employed to answer important questions”.Cohort studies are particularly advantageous for examining rare exposures because subjects are selected by their exposure status. Disadvantages include the need for a large sample size and the potentially long follow-up duration of the study design may be costly.
Quantitative studies emphasize objective measurements and the statistical, mathematical, or numerical analysis of data collected; focusing on gathering numerical data and generalizing it across groups of people or to explain a particular phenomenon (Babbie, 2010:Muijs, 2010). Quantitative analysis will allow researchers to test specific hypotheses, and it’s statistical nature allows for generalization. However, due to the nature of this study it can be argued that a qualitative approach may also be beneficial, or indeed a mixed method study. A qualitative aspect would allow the researchers to assess the psychological impact of behaviour in a social contect, although, this data would be extremely difficult to analyse and link with the quantitative numerical date in order to create a reliable conclusion (McLeod, 2008).
This study will take place in a single centre as paediatric radiotherapy is only performed in large cancer centres that have specialist radiographers. There are only 21 specialist centres for treating children’s cancer in the United Kingdom (Children with Cancer UK, 2017). This will give the researcher better control over the study and can improve internal validity as all patient information will be in one place. However, it could possibly introduce bias as it will not receive input from specialists from other centres that would be involved if it were a multicentre study.
3.2 Sample size
A frequent methodological issue is sample size limitations withing pediatric oncology due to the relatively small patient population in any one institution (Patenaude & Kupst, 2005). In some of these cases the problem can be reduced by switching to a multi-institutional study. However, issues then arise regarding comparability of care (even though the same protocol is used) and the cost of the study increases. Research that is conducted within the Children’s Oncology Group offers a lager number of potential participants but introduces other issues, such as, long lag time for multistage research approval within a large group (Armstrong & Reaman, 2005).
What can be most critical regarding sample size is not the number of participants but their ability to access the most appropriate sample for the research question being asked. For many researchers a sample size between 30 and 500 at 5% confidence level is seen as generally sufficient; however, the size should reflect the general population for which it applies (Morse, 2010). Due to the small number of paediatric cancer patients who receive radiotherapy the suggested sample size for this study would be 30 participants. It would take approximately 3 years for a single centre to treat this volume of paediatric patients.
3.3 Participant criteria
- Age range
Children younger than 3 years of age are extremely difficult to hypnotize due to their low attention span. Teenagers have a reduced imagination and sense of fantasy making them also difficult to hypnotise. This means the age range for this study will be ages 3 through to 12 years (Saadat & Kain, 2007:Goldet al., 2007).
Both sexes will be included in the study as there has been no study that distinguishes a difference between the experienced distress throughout treatment between boys and girls.
- Learning difficulties
Severely autistic children will be excluded from the study as they have little capacity for interpersonal relationships (synapse, n.d.). Therefore they are unlikely to respond to the hypnotic induction.
Those patients who must receive anaesthesia throughout treatment will not be able to receive hypnosis alongside it as hypnosis requires the participant to be conscious. These patients will be excluded from the study.
- Palliative Treatment intent
Due to the fact that the aim of the study is to reduce the long-term effects of radiotherapy, palliative treatment will be excluded from the study. This is also due to the time constraints revolved around palliative treatment which does not allow enough time for hypnosis induction and conditioning.
3.4 Data collection
In spite of the ability to use computer databases to locate participants; the mobility of young adults within the United Kingdom, and gaps in medical continuity that can often occur during the transition from paediatric to adult care makes tracing long-term paediatric oncology survivors difficult and expensive. The problem of locating the participants adds another difficulty to long-term studies that attempt to assess patients at intervals over the course of their adolescent and young adult years.
When the question to be answered revolves around the description of the cancer experience, then paediatric cancer-specific measurements are the most appropriate. Among the several well-designed measures, the most commonly used paediatric cancer-related measures cited in recent literature are the Pediatrics’s Cancer Quality of Life Inventory (PedsQL) and the Paediatric Oncology Quality of Life Scale (POQOLS). As well as these specialist measures, the standard full-scale intelligence quocient and verbal intelligence (IQ) will also be used, making it easier to compare data to the population who will not have completed the PedsQL and POQOLS.
The PedsQL scale takes just 4 minutes to complete and can be completed at home by either the parent or child, thus reducing the potential inconvenience to participants caused by repeated visits to the hospital (Varni, 2017). It is also available in multiple languages for participants whose first language may not be English. The PedQL measures; physical functioning, emotional functioning, social functioning, and school functioning giving the researcher an all round assessment of the participant(Varni, 2017).
Copies of the PedsQL can be seen in Appendix 2.
As participants age the use of the PedsQL and POQOLS becomes less appropriate, therefore, the collection of data will be limited to the standard IQ tests rather than the paediatric cancer specific measurements. Studies show that the development of the human brain is complete by the age of 25, meaning that any effect the radiotherapy will have had would be evident by this age (Massachusetts Institute of Technology, 2008). Therefore, the final collection will be when each participant reaches 25 years of age, meaning the maximum length of time the study will last is 22 years.
3.5 Experimental procedure
The child must first go through an induction and conditioning session with a hypnotherapist who specializes in children, This will last approximately 1 hour. The first session should involve the child, parent or guardians and the hypnotherapist. It is a time for establishing some trust. During the therapy the hypnotherapist will use simple methods that might include things such as stories, visualisation, pretending, hero and media characters, and other imagination tools; often based upon the child’s interests as revealed in the initial session. This can be very informal, for example, inviting the child to listen to or participate in a story or fantasy.The physician will use the technique to which they are accustomed to within the centre, and tailor it to meet the developmental age of the child.
The hypnotherapist will attend the first few fractions of each child’s treatment to ensure that the hypnosis is going to plan and to pass over control to a radiographer that will be present for every fractionation. The radiographer who will take over the hypnosis will have spent time attending training sessions with the hypnotherapist.
Peebles-Kleiger ( 2000) discussed several characteristics of effective hypnotic interventions, including:
- The use of a calm but direct voice.
- Pacing the rate of speech to the patient’s breathing, then gradually slowing down.
- The use of strategic pauses to enhance dissociation.
- An emphasis on words that carry intented suggestion.
- An avoidance of negative phrases.
- The use of positive expectations and suggestions.
These will all be followed throughout the hypnosis process, as well as some tactics tailored to children. Paediatric patient hypnotic interventions should be focused on the capture of the childs focus and trust, thus reframing the child’s distress. Even though a child is directed through hypnosis by a medical professional, they are always in control and can “wake up” whenever she or he desires to do so.
The final stage is the awakening procedure. This needs to be done slowly and gently. If woken abruptly from a deep sleep the subsequent moments are frequently distressing and when this awakening process is abrupt it breaks rapport and lowers susceptibility/suggestibility for future sessions (Cowen, 2004).
The measures will be repeated at each of the patients follow up appointments post treatment for as long as possible with data released and publicized after each follow-up. The Children’s Oncology Group (2013) recommend this to be at least every 5 years if there are no further complications, but ideally every 2 years.
3.6 Data analysis
The normal first step of analysis is usually the development of summary statistics or central tendency. However, the arithmetic mean or standard average, often simply called the ‘mean’ is an invalid parameter when analysing data on a scale, as is the standard deviation which is normally a standard measurement (Allen & Seaman, 2007). Therefore, nonparametric procedures based upon the rank, median and range, are more appropriate for this data, these would include distribution free methods such as; tabulations, contingency tables and chi-squared tables. This is the systematic organization of data into a condensed form allowing analysts to see patterns and trends within the scales that may have been otherwise missed. This form of analysis also allows the data to be easily transferred into graphs and charts which can help breakdown a large volume of figures into individual trends, making any finds and conclusions easier to visualise.
Once the data has been collected it will be communicated to the public by presenting data as:
- graphical displays
However, for the Social Sciences the best well used data analysis package is SPSS (Statistical Package for the Social Sciences) – specifically designed to deal with data and generate statistics. This package enables the analysis of data more fully than using a spreadsheet program such as Microsoft Excel. The above mathematical measurements will still be used. They will be generated by the SPSS, making it more valid and generating the results faster.
4.0 Ethical considerations
Medical research involving children advances child health and wellbeing making it essential (Medical Research Council, 1991). It is not often sufficient, scientific, or ethical to carry out research with consenting adults and apply the findings to paediatrics (Council for Interntional Organizations of Medical Sciences, 2002). This is because the physiology of children is dissimilar to that of adults.Treatments designed specifically to meet the needs of children ensure that age-related differences in drug handling and/or effects are recognised, the doses needed for efficacy are understood, and that any adverse effects can be avoided. Children are not small adults, and so for hypnotherapy to be effective its delivery must suit their needs and be customized to fit their intellectual level.
Whilst the adult population have a responsibility to protect children, we also have an ethical obligation to ensure that they receive the best treatment possible. They should be given the opportunity to benefit from the results of successful research. Children should therefore have the opportunity to participate while being protected from any hazards that involvement in the research project might bring. The risk of this study is classified as minimal. This means that the research will not result in more than a very slight and temporary negative impact on the health of the person concerned, these side effects are rare and include; headaches and slight dizziness after the hypnosis experience (Medical Research Council, 1998: Mayo Clinic, 2015).
Organisations such as the Council for International Organizations of Medical Sciences play a vital part in considering how ethical principles can be effectively applied. While research may have associated risks, it can also offer potential benefits to all participants, including children. Changes in the way we regard children include a growing recognition of the importance of listening to the views, wishes and autonomy of children. They are now viewed as active participants within research, whereas, the were previously seen as subjects of the research (World Medical Association General Assembly, 2000).
Children require special protection because they are less likely than adults to be able to express their needs or defend their interests ; they may not have the capacity to give consent. Consent is only legally valid and professionally acceptable where the participants (or their parental guardian) are competent to give consent, have been properly informed, and have agreed without coercion (British Medical Association, 2001) Children are able to consent themselves once they reach the age of 16, however children younger than this can consent themselves if they are believed to be intelligent enough to have a full understanding to appreciate the medical procedure, this is legally referred to as being Gillick competent (NHS Choices, 2016). The process of obtaining consent requires far more than a signature. The parent or guardian must be appropriately informed of all aspects of the study prior to consenting. Generally, it is believed that where children have sufficient understanding and intelligence to understand what is proposed, it is their consent and not that of their parent/guardian that is required by law (Medical Protection, 2014). Ethically it is important to involve children as much as possible in decisions about their own health, wellbeing and healthcare (General Medical Council, 2013). The participants and their parents/guardians will be provided with information sheets regarding both radiotherapy (hospitals own leaflet) and the study itself (see appendix 3) prior to being consented for the study. Once the child and parents/guardians have been efficiently informed of all aspects of the study, an appropriate length of time will be allowed before consent is gained, to ensure that the family have thought it through thoroughly and are prepared to commit to their treatment with the research.
See appendix 4 for a copy of the intended consent form.
Where the Clinical Trial Regulations apply, a minor is defined as someone under the age of 16 (Medical Research Council, 1991). Therefore in the case of this study it will be the parents or guardians that will be giving legal consent for their child to take part in the research. However, the child will have the opportunity to voice any of their own concerns and ask questions about the study to ensure that they are happy and confident to continue. Methods used to facilitate the consent process will be appropriate to the age and understanding of the child, this may be through a play therapists and audiovisual content such as videos. However, children below school age may still struggle to understand the different aspects of the study in which case it is the parents/guardians decision to as to whether or not to involve the child in their decision making process (General Medical Council, 2013). This is important as a long-term study it is necessary for the child to be willing and confident to continue. Once the participants are legally competent they have the right to withdraw themselves from the study at any time.
Medical professionals have a duty of confidentiality to all patients including children. Children who lack competence to consent to participate are nevertheless entitled to confidentiality. Any decision to disclose confidential information to a third party must be relayed to the child and parent/guardians before disclosure (Medical Research Council, 2003). Within this study it is not foreseen that this will occur. However, the participants will be informed of this prior to starting. It is also important that any identifying paper work must be stored responsibly; either electronically, in a password protected folder or physically, in a locked and secure filing system. This applies to all personal information regarding the participants for the duration of the study. The Data Protection Act specifies no minimum or maximum length of time regarding the storage of data, and this data will be stored for an indefinite length of time (Information Commissioners Office, 2017). This means that the information will be deleted when it is no longer needed for statistical or research purposes.
The researchers working with children will have important responsibilities in relation to child protection. Where researchers have reasonable cause to suspect that a child is suffering or likely to suffer significant harm, they have a clear responsibility to liaise urgently with those responsible for the child’s clinical care with a view to making a referral to social services. Again, a decision to disclose information should, wherever possible, be discussed with the child before disclosure in terms appropriate to the child’s capability to understand.
The following principles should be used as a guide throughout the entirety of the study period:
- The purpose of the research is to obtain knowledge relevant to the health, wellbeing and healthcare needs of children. If at any point this is not deemed to be happening, the study should be stopped as the interests of the child participants must be put before the requirements of the research.
- A child’s refusal to participate or continue in the research should always be respected.
- If a child becomes upset by a procedure, researchers must accept this as a valid refusal.
- Research involves partnership with the child and/or family, who will be kept informed throughout the separate stages of the project. Obtaining consent is a continuing process, rather than a one-off occurrence.
- Researchers must take account of the cumulative medical, emotional, social and psychological consequences of the child being involved in research.
- All data and information collected shall remain confidential and securely stored.
Robison (2003) believes that continuing the contact between researchers and survivors will not only have positive effects on research, serving as an “early warning system” for yet unrecognized effects, but will also be a means of providing education to those currently going through or having just completed treatment about the late effect risks and intervention options. As the value of continuing follow-up with paediatric oncology survivors is recognized, efforts to maintain contact over time will be seen as a priority, making studies like this one easier; thus helping future generations.
In order to reflect upon this piece of work I have decided to use Gibbs Reflective Cycle (1988). By using this method it will break my reflection down into six specific stages, these are; experience, feelings, evaluation, analysis, conclusion, and action plan.
The experience of writing this research proposal has been both exciting and challenging. With the little experience that I have with research I found it difficult to organize my time in a way that I was able to commit enough time into reading into reading the materials required, as well as understanding and learning the appropriate terminology and write effective analysis. Although I understood that this project would take up a considerable amount of time and commitment I feel like I spent too much time reading and worrying about having enough knowledge of every aspect prior to writing. This meant that I did not allot enough time to get my understanding written in a way that best portrays my knowledge. Supervision is something else that I did not take advantage of enough throughout this project. This could have been due to my late start in writing, but if I were to undertake another similar project I will be sure to use the experience and knowledge of my supervisor more, which although was a disadvantage to this project, I now know for any future research.
What I enjoyed most about this piece of work was the literature review and the reading it involved. Although it meant changing the way I read a paper, no longer taking what is written at face-value, but learning to critique and analyse as I read. This took some getting used to but I managed to develop this skill reasonably well within the time frame.
The part of this proposal that I found most challenging and difficult was the methodology. I have realized how much work it takes to design a sound method for even the simplest research. The number of, what I believed to be, insignificant issues that I came across while writing surprised and challenged me as they influenced the entirety of my design. Discussing and justifying all of my decisions was frustrating at first as finding relevant literature within such a small field that was also within a reasonable time frame was difficult for this topic. However I feel like I managed to justify everything I could.
Before I began working on this research idea I knew that ethical considerations regarding involving children in medical research was going to be a long and difficult section. However, I was pleasantly surprised when during my reading around this that I found quite so many resources, Acts, and guidelines with clearly set out rules and regulations. This helped my understanding and learning, as well as enabling me to write a step by step break down.
When I decided to base this proposal around paediatric radiotherapy it was based mainly upon my interest in children’s cancer, however I have now developed a passion for the research into the long-term psychological effects that appear later in life as I fell there is a lot more that healthcare professionals can be doing to reduce the side effects as well as support those who have already developed them.
Overall, this project has been time consuming and stressful, however it was beneficial towards my learning and has increased my knowledge and appreciation it takes to conduct research. I know that if I were to conduct a future research proposal that I will be able to put aside appropriate time and manage it to a higher standard, using the resources best available to me to the best of my ability.
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