PDF(Pubmed)
Abstract：
BACKGROUND: Paediatric oncology/haematology patients and their families are confronted with a life-threatening situation for which music therapy can be a cross-linguistic field of action. The creative act of making music together offers the possibility to strengthen competences and make conflicts tangible. Besides its complementing of evidence-based biomedical care, there is little research on the feasibility and efficacy of interactive music therapy including the diagnosed child and their significant others.
METHODS: We conducted an assessor blind, prospective, multicentric feasibility randomized controlled trial (RCT) with subsequent intervention. Including overall 52 child-significant other dyads, INMUT investigates interaction-focused music therapy with cancer-affected children and their significant others (INMUT-KB; n = 21) compared to music therapy only with the child (MUT-K; n = 21) and a wait-list group (WLG; n = 10). The measurement points include the screening for a cancer diagnosis, psychometric baseline (pre-T1), initial assessment (T1/T2), music therapy sessions (T3-T9), final assessment (T10), final psychometric evaluation (post-T10), and 3-month follow-up (cat-T11). Feasibility and acceptability of the (1) research methodology, (2) intervention and (3) estimation of effect sizes will be assessed using qualitative and quantitative data. The proposed primary outcome includes the parent-child interaction (APCI), and the proposed secondary outcomes refer to subjective goal achievement (GAS), quality of life (KINDL), system-related functional level (EXIS), psychosocial stress (BAS), psychosomatic complaints (SCL-9k), and resources (WIRF). We plan to investigate the efficacy of INMUT-KB and MUT-K post-intervention (post-T10) within the RCT design and at 3-month follow-up (cat-T11).
CONCLUSIONS: This study will provide insights into the feasibility of INMUT and the final sample needed for a confirmatory RCT. We will reflect on successfully implemented study procedures and, if necessary, provide recommendations for changes considering the design, procedures, measures, and statistical analyses. The discussion will conclude with an evaluation whether a confirmatory RCT is worth the investment of future resources, including the calculated number of child-significant other dyads needed based on the efficacy trends derived from this feasibility study.
BACKGROUND: ClinicalTrials.gov: NCT05534282; date of registration: June 23, 2022.
METHODS: We conducted an assessor blind, prospective, multicentric feasibility randomized controlled trial (RCT) with subsequent intervention. Including overall 52 child-significant other dyads, INMUT investigates interaction-focused music therapy with cancer-affected children and their significant others (INMUT-KB; n = 21) compared to music therapy only with the child (MUT-K; n = 21) and a wait-list group (WLG; n = 10). The measurement points include the screening for a cancer diagnosis, psychometric baseline (pre-T1), initial assessment (T1/T2), music therapy sessions (T3-T9), final assessment (T10), final psychometric evaluation (post-T10), and 3-month follow-up (cat-T11). Feasibility and acceptability of the (1) research methodology, (2) intervention and (3) estimation of effect sizes will be assessed using qualitative and quantitative data. The proposed primary outcome includes the parent-child interaction (APCI), and the proposed secondary outcomes refer to subjective goal achievement (GAS), quality of life (KINDL), system-related functional level (EXIS), psychosocial stress (BAS), psychosomatic complaints (SCL-9k), and resources (WIRF). We plan to investigate the efficacy of INMUT-KB and MUT-K post-intervention (post-T10) within the RCT design and at 3-month follow-up (cat-T11).
CONCLUSIONS: This study will provide insights into the feasibility of INMUT and the final sample needed for a confirmatory RCT. We will reflect on successfully implemented study procedures and, if necessary, provide recommendations for changes considering the design, procedures, measures, and statistical analyses. The discussion will conclude with an evaluation whether a confirmatory RCT is worth the investment of future resources, including the calculated number of child-significant other dyads needed based on the efficacy trends derived from this feasibility study.
BACKGROUND: ClinicalTrials.gov: NCT05534282; date of registration: June 23, 2022.
摘要：
背景：儿科肿瘤科/血液科患者及其家人面临危及生命的情况，音乐疗法可能是跨语言的行动领域。共同创作音乐的创造性行为提供了增强能力并使冲突切实可见的可能性。除了补充循证生物医学护理，关于互动音乐疗法的可行性和有效性的研究很少，包括被诊断的孩子和他们的重要其他人。
方法：我们进行了评估，prospective,多中心可行性随机对照试验（RCT）并进行后续干预。包括总共52个儿童显著的其他二元组，与仅对儿童（MUT-K;n=21）和等待名单组（WLG;n=10）的音乐疗法相比，INMUT调查了与受癌症影响的儿童及其重要其他人（INMUT-KB;n=21）的以互动为重点的音乐疗法。测量点包括癌症诊断的筛查，心理基线（T1前），初始评估（T1/T2），音乐疗法（T3-T9），最终评估（T10），最终心理测量评估(T10后)，和3个月的随访（cat-T11）。（1）研究方法的可行性和可接受性，（2）干预和（3）效果大小的估计将使用定性和定量数据进行评估。拟议的主要结果包括亲子互动(APCI)，建议的次要结果是指主观目标成就(GAS)，生活质量（KINDL），与系统相关的功能级别(EXIS)，社会心理压力（BAS），心身投诉（SCL-9K），和资源（WIRF）。我们计划在RCT设计和3个月随访（cat-T11）中调查INMUT-KB和MUT-K干预后（T10后）的疗效。
结论：这项研究将为INMUT的可行性和验证性RCT所需的最终样本提供见解。我们将反思成功实施的学习程序，如有必要,为考虑设计的变更提供建议，程序,措施，和统计分析。讨论将以评估确认性RCT是否值得投资未来资源结束，包括根据本可行性研究得出的疗效趋势所需的儿童显著其他二元组的计算数量。
背景：ClinicalTrials.gov：NCT05534282；注册日期：2022年6月23日。
方法：我们进行了评估，prospective,多中心可行性随机对照试验（RCT）并进行后续干预。包括总共52个儿童显著的其他二元组，与仅对儿童（MUT-K;n=21）和等待名单组（WLG;n=10）的音乐疗法相比，INMUT调查了与受癌症影响的儿童及其重要其他人（INMUT-KB;n=21）的以互动为重点的音乐疗法。测量点包括癌症诊断的筛查，心理基线（T1前），初始评估（T1/T2），音乐疗法（T3-T9），最终评估（T10），最终心理测量评估(T10后)，和3个月的随访（cat-T11）。（1）研究方法的可行性和可接受性，（2）干预和（3）效果大小的估计将使用定性和定量数据进行评估。拟议的主要结果包括亲子互动(APCI)，建议的次要结果是指主观目标成就(GAS)，生活质量（KINDL），与系统相关的功能级别(EXIS)，社会心理压力（BAS），心身投诉（SCL-9K），和资源（WIRF）。我们计划在RCT设计和3个月随访（cat-T11）中调查INMUT-KB和MUT-K干预后（T10后）的疗效。
结论：这项研究将为INMUT的可行性和验证性RCT所需的最终样本提供见解。我们将反思成功实施的学习程序，如有必要,为考虑设计的变更提供建议，程序,措施，和统计分析。讨论将以评估确认性RCT是否值得投资未来资源结束，包括根据本可行性研究得出的疗效趋势所需的儿童显著其他二元组的计算数量。
背景：ClinicalTrials.gov：NCT05534282；注册日期：2022年6月23日。
