一项音乐治疗改善临终关怀住院患者生活质量的随机对照先导和可行性研究。
A randomised controlled pilot and feasibility study of music therapy for improving the quality of life of hospice inpatients.
机构信息
Department of Social Sciences and Social Work, Bournemouth University, Bournemouth, England.
School of Social Sciences, Education and Social Work, Queen's University Belfast, Belfast, Northern Ireland.
出版信息
BMC Palliat Care. 2018 Nov 27;17(1):125. doi: 10.1186/s12904-018-0378-1.
BACKGROUND
Evidence about the effectiveness of music therapy for improving the quality of life of palliative care patients is positive but weak in terms of risk of bias.
METHODS
This study aimed to determine the feasibility of a randomised controlled trial to evaluate the effectiveness of music therapy for improving the quality of life of hospice inpatients, as measured by the McGill Quality of Life questionnaire. Objectives included recruitment of 52 participants over 12 months and provision of data to support the calculation of the required sample size for a definitive randomised trial, taking into account the retention rates of recruited participants; and evaluation of the viability of the intervention and the acceptability of the assessment tool. The design was a single-centre, researcher-blinded randomised pilot and feasibility study involving two parallel groups. Participants were recruited from one inpatient hospice unit in Northern Ireland. Eligibility criteria were an Eastern Cooperative Oncology Group performance status of two or lower and an Abbreviated Mental Test score of seven or more. Consenting patients were randomly allocated to the intervention or control group using a 1:1 allocation ratio. The intervention group received up to six individual music therapy sessions over 3 weeks in addition to usual care. The control group received usual care only.
RESULTS
Fifty one participants were recruited over 12 months. Twenty five were allocated to the intervention group and 26 to the control group. Seventy one percent of participants were lost to follow up by week 3, the proposed primary endpoint. The primary endpoint was moved from week 3, when 71% were lost to follow up to week 1, when 33% were lost. The McGill Quality of Life questionnaire was generally acceptable to participants. In order to detect a small to moderate effect size of 0.3, a fully powered study would require the recruitment of 698 participants.
CONCLUSIONS
A Phase III randomised controlled trial to evaluate the effectiveness of music therapy in improving the quality of life of hospice inpatients is feasible.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT02791048 . Registered 6 June 2016.
背景
有关音乐疗法改善姑息治疗患者生活质量的有效性的证据是积极的，但在偏倚风险方面较弱。
方法
本研究旨在确定一项随机对照试验的可行性，以评估音乐疗法对改善临终关怀住院患者生活质量的有效性，采用麦吉尔生活质量问卷进行测量。目标包括在 12 个月内招募 52 名参与者，并提供数据支持计算用于确定具有保留率的招募参与者的明确随机试验所需的样本量；以及评估干预措施的可行性和评估工具的可接受性。设计为单中心、研究人员盲法随机先导和可行性研究，包括两组平行组。参与者从北爱尔兰的一家住院临终关怀病房招募。入选标准为东部合作肿瘤学组表现状态为 2 或更低，以及简短精神测试分数为 7 或更高。同意参加的患者采用 1:1 分配比例随机分配到干预组或对照组。干预组除常规护理外，还接受最多 6 次个体音乐治疗。对照组仅接受常规护理。
结果
在 12 个月内招募了 51 名参与者。25 名参与者被分配到干预组，26 名参与者被分配到对照组。71%的参与者在第 3 周（即主要终点）时失去随访。主要终点从第 3 周（71%的参与者失去随访）转移到第 1 周（33%的参与者失去随访）。麦吉尔生活质量问卷通常为参与者所接受。为了检测 0.3 的小到中等效应大小，完全有力的研究需要招募 698 名参与者。
结论
评估音乐疗法改善临终关怀住院患者生活质量的有效性的 III 期随机对照试验是可行的。
试验注册
ClinicalTrials.gov：NCT02791048。注册日期 2016 年 6 月 6 日。
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