研究方案：个体化音乐治疗痴呆症患者 - 改善机构照护中痴呆症患者的生活质量和社会参与度。
Study protocol: individualized music for people with dementia - improvement of quality of life and social participation for people with dementia in institutional care.
机构信息
Department of Counseling and Clinical Intervention, Institute of Psychology, Friedrich Schiller University of Jena, Humboldtstrasse 11, 07743, Jena, Germany.
出版信息
BMC Geriatr. 2018 Dec 14;18(1):313. doi: 10.1186/s12877-018-1000-3.
BACKGROUND
People with dementia (PwD) experience a range of negative behavioral and psychological symptoms which can lower their quality of life. Because of the increasing prevalence of dementia, interventions that maintain and enhance the quality of life for PwD are needed. Listening to individualized music constitutes a promising non-pharmacological intervention for PwD. However, despite some preliminary results, evidence regarding the effectiveness of such interventions has been mixed and previous studies have shown a number of methodological limitations. In a randomized controlled trial, we address the limitations of previous research and assess the feasibility, efficacy, and acceptability of an individualized music intervention for PwD living in a nursing home.
METHODS
Residents with dementia from four to five nursing homes in Germany will be randomly assigned to either an intervention or control group. The intervention group will listen to personally-relevant music for 20 min every other day for six weeks. Nursing staff will assess participants' quality of life and problem behavior at the six-week baseline, pretest, posttest, and at the six-week follow-up. Additionally, the participants' behavior will be observed during the intervention period by project staff. The implementation, acceptance, and applicability of the intervention will also be evaluated.
DISCUSSION
The study results will show whether an individualized music intervention can improve the quality of life for PwD living in a nursing home. Additionally, it will provide valuable insight into the acceptability and implementation of an individualized music intervention in the institutional care setting. If the individualized music intervention proves to be effective and widely applicable, it could be implemented on a large scale in institutional care as an easy-to-administer intervention.
TRIAL REGISTRATION
German Clinical Trials Register DRKS00013793 ; ISRCTN registry, ISRCTN59052178 , date applied 27 February 2018, date assigned 4 April 2018, retrospectively registered.
背景
痴呆症患者（PwD）会经历一系列负面的行为和心理症状，从而降低他们的生活质量。由于痴呆症的发病率不断上升，因此需要采取干预措施来维持和提高 PwD 的生活质量。听个性化音乐是一种有前途的非药物干预措施，适用于痴呆症患者。然而，尽管有一些初步的结果，但此类干预措施的有效性证据参差不齐，且之前的研究表明存在一些方法学上的局限性。在一项随机对照试验中，我们解决了之前研究的局限性，并评估了个性化音乐干预措施对居住在养老院的痴呆症患者的可行性、疗效和可接受性。
方法
来自德国四家养老院的四到五名痴呆症患者将被随机分配到干预组或对照组。干预组将每隔一天听 20 分钟与个人相关的音乐，为期六周。护理人员将在六周的基线、前测、后测和六周的随访中评估参与者的生活质量和问题行为。此外，项目工作人员将在干预期间观察参与者的行为。还将评估干预措施的实施、接受和适用性。
讨论
研究结果将表明个性化音乐干预措施是否可以改善居住在养老院的痴呆症患者的生活质量。此外，它将为在机构护理环境中接受和实施个性化音乐干预措施提供有价值的见解。如果个性化音乐干预措施被证明是有效且广泛适用的，那么它可以在机构护理中大规模实施，作为一种易于管理的干预措施。
试验注册
德国临床试验注册中心 DRKS00013793；ISRCTN 注册中心，ISRCTN59052178，申请日期为 2018 年 2 月 27 日，分配日期为 2018 年 4 月 4 日，为回顾性注册。
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