Department of Breast and Urological Oncology, Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, China.
Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan University, Wuhan, China.
BMC Psychol. 2024 Sep 27;12(1):508. doi: 10.1186/s40359-024-02028-6.
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.
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.
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.
This study is registered at the Chinese Clinical Trial Registry, ChiCTR2400082622. Registered 2 April, 2024.
医疗恐惧是住院儿童中常见的心理反应，尤其是在中枢神经系统 (CNS) 癌症的放射治疗期间。这种恐惧不仅会引起焦虑和抑郁等负面情绪，还会影响儿童的生活质量和治疗结果。放射治疗期间环境陌生和与父母分离等因素会加剧这种恐惧。儿童生活作为一种专业服务，通过医疗理解和心理准备为儿童提供身心支持，满足他们的社会和心理需求等。本研究旨在构建一个全面的儿童生活干预方案 (CCLIP)，由四个关键组成部分组成：心理调整和准备、治疗性游戏、疼痛管理和应对策略以及家庭支持。整合有效的干预方法旨在减少接受放射治疗的儿童的医疗恐惧，促进心理健康，提高治疗依从性，提高生活质量。
这是一项随机对照试验的方案。我们使用随机数字表法，计划招募 38 名符合纳入标准的合格儿童，然后将他们随机分为两组：干预组和对照组。干预组将接受 CCLIP，对照组将接受标准化护理。数据将通过问卷和四个不同时间点的现场评估在为期一个月的干预期间收集：入院当天 (T0)、第一次放射治疗定位 (T1)、放射治疗中期 (T2)和放射治疗后 (T3)。主要结局测量指标是 CCLIP 在降低 CNS 癌症接受放射治疗的儿童的医疗恐惧方面的有效性。次要结局包括焦虑、抑郁、辐射依从性、儿童生活质量和父母满意度。
本研究旨在通过实施 CCLIP 减轻 CNS 肿瘤儿童放射治疗期间的医疗恐惧，同时增强他们的心理健康和生活质量。本研究的预期结果包括为临床实践提供有效的干预策略，改善儿童的治疗体验和长期预后，并对儿童及其家庭产生积极影响。
本研究在中国临床试验注册中心注册，注册号 ChiCTR2400082622。注册于 2024 年 4 月 2 日。
