Valero-Cantero Inmaculada, Carrión-Velasco Yolanda, Casals Cristina, Martínez-Valero Francisco Javier, Barón-López Francisco Javier, Vázquez-Sánchez María Ángeles
Puerta Blanca Clinical Management Unit, Malaga-Guadalhorce Health District, Málaga, Spain.
Tiro Pichón Clinical Management Unit, Malaga-Guadalhorce Health District, Málaga, Spain.
BMC Nurs. 2020 Nov 16;19(1):107. doi: 10.1186/s12912-020-00501-2.
Sleep disorders are commonly experienced by community caregivers for persons with cancer, with at least 72% reporting moderate to severe disorders. A consequence of this condition, which is associated with the presence of overload in the caregiver, is the increased risk of clinical depression. The aim of this study is to evaluate the effects of music on the sleep quality achieved by informal caregivers for cancer patients receiving home palliative care. In addition, we will assess the influence of specific variables that could modify these effects, analyse the correlates related to nocturnal wakefulness and consider the diurnal consequences according to the sleep characteristics identified.
This single-blind, multicentre, randomised clinical trial will focus on informal providers of care for cancer patients. Two samples of 40 caregivers will be recruited. The first, intervention, group will receive seven music-based sessions. The control group will be masked with seven sessions of therapeutic education (reinforcing previous sessions). Outcomes will be evaluated using the Pittsburgh Sleep Quality Index, a triaxial accelerometer, EuroQol-5D-5L, the Caregiver Strain Index, the Epworth Sleepiness Scale and the Client Satisfaction Questionnaire. The caregivers' satisfaction with the intervention performed will also be examined.
This study is expected to extend our understanding of the efficacy of music therapy in enhancing the sleep quality of caregivers for patients receiving home palliative care. To our knowledge, no reliable scientific investigations of this subject have previously been undertaken. Music is believed to benefit certain aspects of sleep, but this has yet to be proven and, according to a Cochrane review, high-quality research in this field is necessary. One of the main strengths of our study, which heightens the quality of the randomised clinical trial design, is the objective assessment of physical activity by accelerometry and the use of both objective and subjective measures of sleep in caregivers. Music therapy for the caregivers addressed in this study is complementary, readily applicable, provokes no harmful side effects and may produce significant benefits.
The IMECA study is registered at Clinical Trials.gov, ClinicalTrials.gov Identifier: NCT04491110 . Registered 29 July, 2020.
癌症患者的社区照护者普遍存在睡眠障碍，至少72%的照护者报告有中度至重度睡眠障碍。这种情况与照护者负担过重有关，其后果是临床抑郁症风险增加。本研究的目的是评估音乐对接受家庭姑息治疗的癌症患者的非正式照护者的睡眠质量的影响。此外，我们将评估可能改变这些影响的特定变量的影响，分析与夜间觉醒相关的因素，并根据所确定的睡眠特征考虑日间后果。
这项单盲、多中心、随机临床试验将聚焦于癌症患者的非正式照护提供者。将招募两个样本，每个样本40名照护者。第一个干预组将接受七次基于音乐的疗程。对照组将接受七次治疗性教育疗程（强化之前的疗程）。将使用匹兹堡睡眠质量指数、三轴加速度计、欧洲五维度健康量表、照护者压力指数、爱泼华嗜睡量表和客户满意度问卷来评估结果。还将考察照护者对所实施干预的满意度。
本研究有望扩展我们对音乐疗法在提高接受家庭姑息治疗患者的照护者睡眠质量方面疗效的理解。据我们所知，此前尚未对该主题进行过可靠的科学研究。人们认为音乐对睡眠的某些方面有益，但这尚未得到证实，根据考克兰系统评价，该领域需要高质量的研究。我们研究的主要优势之一是通过加速度计对身体活动进行客观评估，并使用客观和主观的睡眠测量方法来提高随机临床试验设计的质量。本研究中针对照护者的音乐疗法具有辅助性、易于应用、无有害副作用且可能产生显著益处。
IMECA研究已在ClinicalTrials.gov注册，ClinicalTrials.gov标识符：NCT04491110。于2020年7月29日注册。
