Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial

Summary

Introduction Sleeping problems experienced by cancer patients carers are frequent with 72% of carers reporting moderate to severe problems. Another consequence for this carers is the increase of suffering from depression and it is usually associated to carer overload.

Objectives

Main objective:

\- To evaluate the effects of listening to music in sleep quality for oncology patients non-professional carers at home, and to evaluate the influence of specific factors that may modify that effect.

Secondary objectives:

* To assess the relationship between the waking state and the consequences during the day according to sleep characteristics. These include:

1\. Psychological results:
1. Quality of life.
2. Carer overload.

2\. Physical results:
1. Sleepiness during the day.
2. Physical activity, intensity and length evaluation.
* To assess carers satisfaction with the intervention.

Method Randomized clinical trial, single blinding and performed in oncological patients carers in several practices. 2 samples of 40 carers. Intervention group will be taken through a seven session intervention with music; control group will undergo seven sessions of therapeutic education (as a reminder). Results will be evaluated using Pittsburgh Quality of Sleep Index, triaxial accelerometer, EuroQol-5D-5L, Caregiver Strain Index, Epworth Sleepiness Scale and Client Satisfaction Questionnaire.

Statistical analysis Basal values will be compared for both groups. Then the values before and after the intervention will be compared using Student's t distribution for normal continuous variables, and Wilcoxon's T test for paired data in continuous not normal variables. A multiple linear regression will be carried out.

The system developed for the PREDIMEDPLUS study will be used to process accelerometer data results. This semi-automated system manages data capture in a continuous stream in a central server of Malaga University. Processing and analysis of this data is also centralised, with an open source package, GGIR v. 1.5-1248

Conditions

• Music Therapy
• Caregivers
• Sleep
• Palliative Care

Interventions

OTHER

Music Therapy

We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be done by using mobile telephones.

OTHER

simulation with therapeutic education

Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through mobile phones.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

  collaborator OTHER

• Andaluz Health Service

  lead OTHER_GOV

Principal Investigators

• Inmaculada Valero Cantero, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• María Angeles Vázquez Sanchez, Doctor · University of Malaga

• Yolanda Carrión Velasco, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Milagrosa Espinar Toledo, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Cristina Casals Sánchez, Doctor · University od Cádiz

• Librado Valverde Velasco, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Milagros Reyes Sánchez, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Nuria Garcia-Agua Soler, Doctor · University of Malaga

• Francisco Martínez Valero, chiropodist · National Health Service and Midlothian Foot Care, Dalkeith, Lothian, Scotland.

• Francisco Javier Barón López, Doctor · University of Malaga

• Jose Luís Casals Sánchez, Doctor · Hospital Universitario Virgen de la Victoria de Málaga

• Ana Belén Arrabal Téllez, Nurse · Distrito Sanitario Axarquía-Este. Servicio Andaluz de Salud

• Rosa Ana Serrano Benavente, doctor · Distrito Sanitario Axarquía-Este.Servicio Andaluz de Salud

• Julia Wárnberg W, Doctor · University of Malaga

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2022-02-12

Completion

2022-03-15

Countries

• Spain

Study Locations