Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre rando

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Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial Inmaculada Valero-Cantero1, Yolanda Carrión-Velasco2, Cristina Casals3,4* , Francisco Javier Martínez-Valero5, Francisco Javier Barón-López6 and María Ángeles Vázquez-Sánchez7

Abstract Background: 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. Methods: 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 musicbased 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. (Continued on next page)

* Correspondence: [email protected] 3 MOVE-IT Research group and Department of Physical Education, Faculty of Education Sciences, University of Cadiz, Cádiz, Spain 4 Biomedical Research and Innovation Institute of Cadiz (INiBICA) Research Unit, Puerta del Mar University Hospital, Cádiz, Spain Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.o