Research on the comprehensive child life intervention program (CCLIP) for adjusting medical fear in children with central nervous system (CNS) cancers: a randomized controlled trial study protocol

Abstract

Background

Medical fear is a common psychological reaction in hospitalized children, especially during radiotherapy for central nervous system (CNS) cancers. This fear not only causes negative emotions such as anxiety and depression but also affects children’s quality of life and treatment outcomes. It is exacerbated by factors such as unfamiliar environments during radiation therapy and separation from parents. Child Life, as a professional service, offers physical and mental support to children through medical understanding and psychological preparation, addressing their social and psychological needs, among other things. This study aims to construct a comprehensive Child Life intervention program (CCLIP), consisting of four key components: psychological adjustment and preparation, therapeutic play, pain management and coping strategies, and family support. The integration of effective intervention methods aims to reduce medical fear in children undergoing radiotherapy, promote psychological well-being, improve treatment compliance, and enhance quality of life.

Methods

This study is a protocol for a randomized controlled trial. Using a random number table method, we plan to recruit 38 eligible children who meet the inclusion criteria and then randomize them into two distinct groups: the intervention group and the control group. The intervention group will receive the CCLIP, and the control group will receive standardized care. Data will be collected through questionnaires and on-site assessments during the one-month intervention period at four distinct time points: the day of admission (T0), the first radiotherapy positioning (T1), mid-radiotherapy (T2), and postradiotherapy (T3). The primary outcome measure is the effectiveness of the CCLIP in reducing medical fear among children receiving radiation treatment for CNS cancers. Secondary outcomes include anxiety, depression, radiation adherence, quality of life among children, and parental satisfaction.

Discussion

This study aims to alleviate medical fear among children with CNS tumors undergoing radiotherapy through the implementation of the CCLIP while enhancing their mental health and quality of life. The expected outcomes of this research include providing effective intervention strategies for clinical practice, improving the treatment experience and long-term prognosis of children, and having positive impacts on children and their families.

Trial registration

This study is registered at the Chinese Clinical Trial Registry, ChiCTR2400082622. Registered 2 April, 2024.

Background

Medical fear is a painful emotion caused by medical experiences and related events. It is often triggered by illusions of impending pain, danger, or disaster [1, 2]. Medical fear is a common emotional experience for hospitalized children. It includes fear of the medical environment (leaving home, hospitalization, death, etc.), fear of medical procedures (injections, taking medication, etc.), and fear of interpersonal relationships (interfering with learning, lack of knowledge about medical measures, etc.) [3]. At the same time, children feel pain and negative reactions due to fear and unfamiliarity with a series of medical experiences such as illness, examinations, and treatments. Simultaneously, due to fear and unfamiliarity with a range of medical experiences, such as illness, examinations, and treatments, children often feel pain and exhibit negative reactions. In severe cases, individuals may suffer from insomnia, nightmares, and eating regressions, which reduce their cooperation and may also cause psychological trauma, affecting their quality of life [4,5,6]. If medical fear cannot be effectively alleviated, the treatment process for childhood diseases may become more challenging [7].

CNS cancers are among the most common solid cancers in children and are a significant cause of cancer-related deaths in children. According to the Central Brain Tumor Registry of the United States (CBTRUS), the incidence of primary brain cancers and other CNS cancers in children and adolescents is 6.14% [8, 9]. Radiotherapy is a key treatment for these types of cancers [10, 11]. However, factors such as an unfamiliar environment and separation from parents during the radiotherapy process can exacerbate fear, anxiety, and depression in children. It may even require the use of sedatives or general anesthesia, which can lead to side effects such as respiratory depression, aspiration, infection, learning disabilities, decreased attention, and impaired cognitive function [12, 13]. If these emotional issues are not addressed promptly, this will reduce children’s compliance with treatment, affect their disease adaptation and psychological well-being, and even hinder normal growth and development. Therefore, it is crucial to effectively intervene in the medical treatment of children with CNS cancers during radiotherapy.

Child Life focuses on providing professional services for children undergoing medical treatment, including medical cognition, psychological preparation, and social and psychological needs. It aims to alleviate medical fears, anxiety, and psychological trauma through medical adjustment and psychosocial support [14]. It also pays attention to the adaptation and needs of families in the face of illness and medical environments [15]. Child Life has been widely used in various medical institutions to provide comprehensive medical support for pediatric patients [16]. However, in China, Child Life has been implemented for a relatively short period, and there is limited research, which is still in the exploratory stage [17,18,19,20,21]. Therefore, this study aims to develop CCLIP for pediatric patients undergoing CNS tumor radiotherapy. Therapeutic games, videos, dolls, picture books, and other auxiliary treatment methods aim to reduce medical fears, improve negative emotions such as anxiety and depression, and promote the psychological well-being of pediatric patients.

Methods

This study aims to evaluate the effectiveness of the CCLIP in the radiotherapy of pediatric CNS cancers compared to standard care. This study focuses on alleviating medical fears, anxiety, and depression among children, improving their stress-coping abilities, reducing hospitalization time, lowering medical costs, and minimizing the use of sedatives. Additionally, the study strives to enhance the quality of life for children and increase parental satisfaction, ultimately providing compelling evidence for the clinical promotion of the program.

Primary objectives

The main objective of this study protocol is to construct the CCLIP and evaluate its effectiveness in alleviating medical fears among pediatric CNS cancer patients.

Secondary objectives

The secondary objectives of the study are as follows:

• 1. Investigate the impact of this program on anxiety and depression in pediatric cancer patients.

• 2. Increase compliance with radiation therapy among pediatric cancer patients to reduce treatment interruptions and delays, thus optimizing treatment outcomes.

• 3. Assess the positive impact of this program on the quality of life of pediatric cancer patients, especially concerning psychological, emotional, and social functioning.

• 4. Investigate parents’ opinions, satisfaction, and acceptance of the program at the family level.

Study design

The design of this study protocol will utilize a randomized controlled trial to evaluate the effects of CCLIP on pediatric patients undergoing radiotherapy for CNS cancers. Patients will be randomly allocated to either the intervention group receiving the intervention or the control group receiving standard care (refer to Fig. 1). The CONSORT guidelines (Consolidated Standards of Reporting Trials) will be followed to ensure the reliability and accuracy of the research results.

Fig. 1

Patient recruitment, intervention, and evaluation flowchart

Participants

Pediatric patients with CNS cancers will be recruited from the Department of Radiation and Medical Oncology at Zhongnan Hospital of Wuhan University for this study. The research team will assess, together with the attending physician, whether the child is suitable for participation in this study. After the child and their legal guardian sign the written informed consent form, the child will be formally included in the study.

Inclusion criteria

① Clinical diagnosis of CNS cancers [22]. ② Aged between 3 and 14 years old. ③ Able to complete the entire radiotherapy plan. ④ Possessing normal intellectual development with basic language communication and comprehension abilities. ⑤ The children and their legal guardians voluntarily participate in the study and sign the informed consent forms.

Exclusion criteria

① Hearing impairment in children. ② Serious illness or comorbidity with other underlying diseases, such as severe infections. ③ Previously received similar nursing measures. ④ Communication barriers with parents can adversely affect child care and outcomes.

Sample size

Our primary outcome measure was medical fear, which was measured with the Child Medical Fear Scale. To determine an estimated medical fear score, we calculated the sample size for each group using the formula for independent sample mean tests and conducted a literature review [23]. The calculation parameters were set at α = 0.05 and β = 0.10, with a two-tailed test, using the G*Power 3.1.9.2 software. The sample size for each group was calculated to be 16 patients. However, with a potential 15% dropout or attrition rate, the final sample size was adjusted to 19 patients per group [24].

Randomization and blinding

This study follows the principle of randomization and employs simple random sampling to allocate eligible children to the intervention and control groups at a 1:1 ratio. The intervention group will receive the CCLIP, while the control group will receive standard care. The children are numbered sequentially based on the admission order and matched one-to-one with the numbers in the random number table, ensuring equal assignment probability to each group. To maintain fairness and confidentiality in the allocation process, the children’s numbers are placed in sealed envelopes and kept in order. The study adopts a single-blind design, in which only the intervention implementers are aware of the specific protocol. The children, parents, and researchers are unaware of the group assignments throughout the entire trial process to ensure the objectivity and accuracy of the research results.

Intervention protocol

Pediatric patients who meet the screening criteria will be randomly assigned to either the intervention group or the control group, both of whom will undergo a 1-month intervention.

Control group: standard care

Patients in the control group will receive standard care, which includes routine oncology nursing, preparation and care before and after radiotherapy, health education, medication and dietary guidance, psychological care, and discharge instructions. Concurrently, all identified variables will be assessed in both patient groups.

Experimental intervention: CCLIP

In addition to the care given to the control group, the intervention group will implement the CCLIP. Child Life is a comprehensive, multidimensional support system that addresses the psychological and emotional needs of pediatric cancer patients and their families at all stages of the disease. It offers psychological preparation and pain management to patients through nonpharmacological means such as therapeutic play, music, and books and encourages parental involvement in medical procedures [25]. This approach emphasizes close collaboration among healthcare teams, multidisciplinary teams, and families which is a comprehensive psychosocial intervention [26]. Child Life aims to help patients maintain a positive attitude, improve their healthcare experience, alleviate negative emotions and pain, and provide comprehensive support to patients and families [4, 27].

The children’s room in the ward was designated as the intervention site for this study. We carefully arranged every detail, from colors to furniture, to create a warm, comfortable, and child-friendly environment, thereby alleviating tension and anxiety among pediatric patients in the hospital. To offer children diverse psychological support and health education, we prepared medical equipment toys, dolls representing medical staff, oil painting brushes, picture books, projectors, and other items, as well as recorded animation videos about radiation therapy. To ensure that the interventions were professional and effective, we invited a certified child life specialist to guide the process and provided professional training to the implementation personnel. Furthermore, we utilize a variety of other promotional methods, including social media marketing and public service events, to increase public awareness and support, all of which contribute to the recovery and enhancement of the mental health of children. The intervention is divided into four parts, with the specific intervention content described below and shown in Table 1.

Table 1 Overview of the comprehensive child life intervention program

Part one: psychological adjustment and preparation

Recognition stage

Establish a positive relationship with the child and their parents, introduce them to the ward environment, understand the child’s personality traits, and use appropriate language and methods of communication. The participants will be informed about the purpose, methodology, and content of the study.

Preparation for development

When preparing the necessary items for therapeutic play, we explain medical procedures in language and methods that the child can understand and appreciate. Furthermore, we introduce the radiation therapy room, the treatment process, and the necessary precautions to both the child and the parents.

Part two: therapeutic games

Doll models are used to introduce radiation therapy to children, encompassing the environment and positioning, and to demonstrate the procedure. Body language is employed to offer physical comfort to the child during the procedure. By role-playing ‘If I Were a Nurse’ to simulate the radiation therapy process, nurses can help children fully understand and accept the entire process by decorating the mask with drawings based on the child’s preferences while providing assistance and guidance nearby.

Part three: pain management and coping

By diverting methods such as diverting attention, taking deep breaths, imagining delicious food, and engaging in conversation, the child’s attention to the pain caused by invasive procedures can be reduced, alleviating the stress associated with pain. Adjusting the temperature and humidity of the environment and modifying the treatment environment can further increase a child’s comfort.

Part four: family support

Encourage the child and parents to participate in the treatment process together and offer emotional support. Encourage the child to express their emotions, respond to their needs, and help them develop coping strategies. Help parents understand the child’s treatment response and work with them to promote recovery.

Outcome assessment

Sociodemographic and clinical characteristics

Child

Age, sex, medical expense payment method, type of family residence, admission time, diagnosis time, treatment plan, and number and dosage of sedatives or hypnotic drugs used.

Parent (primary caregiver)

Relationship with the child, age, sex, education level, marital status, occupation, economic status, etc.

Child medical fear scale (CMFS)

Broome [28] developed a scale to assess medical fear among hospitalized children. Yan [1] revised the scale to create the Chinese version of the CMFS, which has four subscales: medical procedural fears, healthcare environmental fears, intrapersonal fears, and interpersonal fears. There are seventeen items in total. Each item is scored on a three-point scale, with one indicating “no fear” and three indicating “very fearful”. The total score ranges from 17 to 51, with higher scores indicating greater medical fear. The Cronbach’s α is 0.871.

Modified Yale preoperative anxiety scale-short form (mYPAS-SF)

Jenkins [29] (2014) developed a simplified version of the mYPAS-SF, which Dai [30] (2019) translated, adapted, and culturally validated in a sample of 2 to 12 years. The Chinese version of the mYPAS-SF includes four dimensions: activity, language, emotional expression, and arousal state. The total score ranges from 23 to 100, with higher scores indicating more severe preoperative anxiety in children. The Cronbach’s α for the Chinese mYPAS-SF is 0.850.

Children’s depression inventory (CDI)

The CDI is a self-assessment scale created by the American psychologist Kovacs [31] and is based on the Beck Depression Inventory. It is currently the most commonly used depression scale among children and adolescents. It consists of five subscales—low self-esteem, negative mood, lack of pleasure, low efficacy, and interpersonal problems—for a total of 27 items. Each item has three options for describing the level of depression, which range from 0 to 2. A higher score indicates a more severe case of depression. The Cronbach’s α for the CDI is 0.8504 [32].

Radiation therapy compliance

Li [33] developed an assessment tool for radiation therapy compliance in pediatric cancer patients, which is used to assess the level of cooperation during each radiation therapy session. It is divided into three levels. Excellent: The child does not cry or resist, cooperates with body movements, can complete the entire treatment plan as prescribed by the doctor, and participates well in health education. Good: The child cries but does not resist, completes radiation therapy but does not follow the doctor’s plan, experiences interruptions, and cooperates partially with health education. Poor: The child does not cooperate, cries, exhibits physical resistance, and requires the use of anesthetics to assist in completing radiation therapy. Additionally, the child does not cooperate with health education.

Pediatric quality of life inventory version 4.0 generic core scales (PedsQL 4.0)

Vami [34] developed the scale in 1987, and Chen [35] translated it into Chinese in 2008. It can be assessed using either self-reports or parent-reports and is appropriate for children and adolescents aged 2 to 18 years. The PedsQL encompasses four dimensions—physical, emotional, role, and social functioning—consisting of 23 items. It uses a 0 to 4 Likert 5-point scoring system, with the total score representing the average of the scores in each domain. A higher score reflects a higher quality of life. The Chinese version of the scale has a Cronbach’s α coefficient of 0.90, while the coefficients for each dimension range from 0.74 to 0.82.

Parent satisfaction

The researchers designed the parent satisfaction evaluation questionnaire, which includes six aspects: medical service quality, communication and explanation, facilities and environment, pain management, treatment effectiveness and prognosis, and human care.

Data collection

The research team members will be in charge of collecting all of the data and conducting assessments at four different time points: the day of the child’s admission (T0), the day of radiotherapy positioning (T1), the midpoint of radiotherapy (T2), and the day of postradiotherapy (T3). This information will include demographic information about the child, disease information, treatment plans, and general information about the primary caregiver.

All participants will be evaluated at the specified time points, as shown in Table 2. The assessment will be carried out by an experienced researcher in collaboration with the child and their parents. Before the assessment, the researcher will provide a detailed explanation of the questionnaire and its completion method and carefully observe and answer any questions raised by the participants to ensure a smooth assessment process. After completing the questionnaire, the researcher will promptly check its completeness and hold brief discussions with the child and parents to gain a better understanding of their psychological status and needs.

Table 2 Overview of the assessment schedule

Statistical analysis

Statistical analysis of the data will be conducted using SPSS 21.0 software. For normally distributed continuous data, mean ± standard deviation will be used for description, and an independent sample t-test will be applied for group comparisons. If the data does not follow a normal distribution, the median and quartiles will be used for description, while nonparametric tests (e.g., the Mann-Whitney U test) will be employed for group comparisons. Count data will be presented as frequencies and percentages, and group differences will be analyzed using the chi-square test. For repeated measurement data, appropriate statistical methods, such as repeated measures analysis of variance or generalized estimating equations, will be selected based on the data’s characteristics and analytical requirements. The significance level will be set at α = 0.05, representing a 95% confidence interval.

Data management, data storage, and dissemination policy

The data will be strictly managed to ensure its security, integrity, and confidentiality. A dual-entry and verification method will be adopted to improve the accuracy and reliability of subsequent analyses. All data will be strictly confidential and accessible only to authorized personnel. During the research process, we will strictly adhere to legal, ethical, and safety regulations to protect the privacy rights of participants. As the project leader, Ke Yao will supervise data management to ensure that data collection, processing, storage, and analysis comply with regulations. We regularly back up data monthly to prevent the risk of loss or damage. In addition, data security training will be provided to project team members to raise their awareness of data protection. We are dedicated to protecting research data and providing solid assurances about the legitimacy, security, and high quality of project results.

We will disseminate our research findings via a variety of channels, including academic journals, conferences, online platforms, and project websites. At the same time, we will maintain the accuracy and integrity of all information, refraining from misleading or exaggerating our research findings, and ensuring that the public has access to true and objective information. We hope that this research will provide valuable scientific evidence and solutions for relevant fields, thereby promoting the dissemination and application of scientific knowledge.

Discussion

Our prospective, randomized controlled intervention trial aims to explore the effect of the CCLIP on alleviating medical fear among pediatric patients undergoing CNS radiation therapy for cancers. The purpose is to provide positive child life interventions to pediatric cancer patients, reduce negative emotions, and improve treatment outcomes and hospital experiences while also aiming to lower medical costs. The proposed study protocol is based on Child Life Services [15] and addresses psychological adjustment and preparation, therapeutic play, pain management, and coping strategies, as well as family support. We hope that by providing this comprehensive and multidimensional support system, pediatric patients will be better able to cope with the challenges of illness, understand the steps and processes of radiation therapy, establish a correct understanding of radiation procedures, reduce fear of the unknown, cultivate a positive mindset, enhance their treatment confidence, and actively cooperate with treatment, ultimately improving their quality of life.

Given our limited experience and resources in Child Life programs, we are actively seeking collaboration with the Children’s Hospital Affiliated to Zhejiang University School of Medicine. We have invited Professor Wu Xiaohua, a Certified Child Life Specialist (CCLS), to provide valuable professional guidance. We are aware that there may be difficulties and challenges during project implementation. Therefore, the active participation and support of parents and families are crucial. We will provide family support services and encourage parents to play an active role throughout the process. Due to the young age of the patients, the assessment process may face some special difficulties. We ask researchers to be patient and guide the patients through the assessment in a gentle manner. We will adjust the intervention strategies in time based on feedback to ensure the maximum effectiveness of the intervention.

Through this study, we hope to verify the feasibility of the CCLIP in alleviating medical fear among pediatric cancer patients undergoing radiotherapy. Additionally, we aim to explore its positive impact on enhancing patients’ psychological well-being, overcoming medical fear and negative emotions, and improving their quality of life. Furthermore, we aspire to continuously optimize and refine the intervention plan through practical implementation.