The Effect of Music on Sleep Quality and Comfort in Elderly: a Randomized Controlled Trial

February 22, 2025 updated by: Derin Köksal, Ege University

The Effect of Music on Sleep Quality and Comfort Levels in Elderly Individuals: a Randomized Controlled Trial

The aim of this clinical study is to examine the effects of music on sleep quality and comfort levels in individuals aged 65 and older.

Background Sleep disorders in elderly individuals can negatively affect their comfort and quality of life. Due to its relaxing effect, music can be used as a supportive intervention in nursing care to improve sleep quality and comfort.

Methods

This study was conducted between January and April 2023 in the internal medicine department of a hospital in İzmir, Turkey. Patients aged 65 and older were divided into two groups using simple and stratified randomization:

Music group: Listened to MusiCure® compositions for 30 minutes, three times a week, for one week.

Control group: Received no intervention. Data Collection Process

Data were collected face-to-face on the first and fourth days. The following scales were used:

Richard Campbell Sleep Scale (to assess sleep quality) Short Form of the General Comfort Scale (to measure physical, psychological, and environmental comfort) Key Points Music intervention may positively affect sleep parameters such as sleep duration, sleep onset latency, and nighttime awakenings.

Music can increase psychological and physical relaxation, enhancing comfort levels in elderly individuals.

Considering individual music preferences may improve the effectiveness of the intervention.

Ethical Principles and Approvals The study was approved by the Clinical Research Ethics Committee of İzmir Bakırçay University and was conducted in accordance with the Helsinki Declaration.

This research aims to support the use of music interventions in nursing care and contribute to evidence-based practices to enhance sleep quality and comfort levels in elderly individuals.

Study Overview

Detailed Description

This study is a randomized controlled trial conducted to examine the effect of music intervention on sleep quality and comfort levels in individuals aged 65 and older.

Introduction and Background Sleep disorders in elderly individuals can negatively affect their quality of life and comfort levels. Non-pharmacological approaches stand out as alternative treatment methods due to their lack of side effects and cost-effectiveness. Music therapy is considered an important intervention for improving both sleep quality and overall comfort due to its relaxing effects.

Methods The study was conducted between January and April 2023 in the internal medicine department of a training and research hospital in İzmir, Turkey. Individuals aged 65 and older were included in the study. Participants were divided into two groups: the music intervention group and the control group.

Music group: Listened to MusiCure® compositions for 30 minutes, three times a week, for one week.

Control group: Received standard care without any intervention.

Data Collection Tools:

Richard Campbell Sleep Scale (to assess sleep quality) Short Form of the General Comfort Scale (to measure physical, psychological, and environmental comfort)

Randomization:

Patients were stratified by age (65-74, 75 and older) and gender and assigned to groups using a simple randomization method.

Key Points Music therapy may have positive effects on sleep quality parameters such as sleep duration, sleep onset latency, and nighttime awakenings.

Music can enhance psychological and physical relaxation, thereby increasing comfort levels in elderly individuals.

Considering individual music preferences may enhance the effectiveness of music interventions.

Ethical Principles and Approvals The study was approved by the Clinical Research Ethics Committee of İzmir Bakırçay University and was conducted in accordance with the Helsinki Declaration.

This research aims to provide a scientific basis for the use of music in nursing care and contribute to evidence-based practices to improve sleep quality and comfort in elderly individuals.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Buca
      • Izmir, Buca, Turkey
        • Buca Seyfi Demirsoy Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (a) willingness to participate in the research, (b) proficiency in speaking and understanding Turkish, (c) being 65 years or older, (d) requiring hospitalization for at least one week.

Exclusion Criteria:

  • (a) individuals with known hearing or visual impairments, (b) individuals with sleep disorders, (c) individuals diagnosed with advanced-stage diseases, (d) individuals with a history of cognitive disorders or a diagnosis of major depressive disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Group
For participants in the music group, the purpose of the study was explained before the music intervention, and after obtaining consent, the Individual Diagnosis Form, Richard-Campbell Sleep Scale, and Short Form General Comfort Scale were collected through face-to-face interviews. After the scales were completed, participants listened to the specially composed MusiCure® compositions via headphones and an mp3 player for 30 minutes each day over three days, between 19:00-21:00, considering non-intensive family visit hours and nursing care hours. After the music intervention, data were collected using the Richard-Campbell Sleep Scale and the Short Form General Comfort Scale on the morning of the fourth day after the third music session.
In the music group, "MusiCure®" compositions, which feature soft rhythmic melodies, were chosen. These musical pieces were composed by Danish composer Niels Eje (MusiCure, 2020) and are therapeutic in nature, designed for physical and mental relaxation within a range of 60-80 bpm (Eje, 2020). Literature reviews indicate that the "MusiCure®" album has positive effects on conditions such as pain, well-being, and anxiety (Fredriksson et al., 2009; Nilsson et al., 2009). The pieces to be used in this study were selected after communication with Niels Eje, and the recommended pieces were Winter, Early Spring, Equator, and Ocean Echoes (MusiCure, 2020). The music was presented hygienically to the participants through headphones and played for 30 minutes in four tracks via an mp3 player.
Other Names:
  • music
  • complemantary and alternative Therapies
No Intervention: Control Group
For participants in the control group, the purpose of the study was explained, and after obtaining consent, the Individual Diagnosis Form, Richard-Campbell Sleep Scale, and Short Form General Comfort Scale were administered through face-to-face interviews. Data were collected again, without any intervention, on the morning of the fourth day using the Richard-Campbell Sleep Scale and the Short Form General Comfort Scale. No music intervention was provided to the control group. The control group will receive regular care and activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: Three days after the music intervention.
This study aims to examine how music intervention affects the sleep quality of older individuals. Sleep quality was measured using the Richard Campbell Sleep Scale. This measurement evaluates various dimensions of sleep quality, including sleep duration, depth, frequency of awakenings, sleep onset latency, and environmental factors.
Three days after the music intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort Levels
Time Frame: Three days after the music intervention
The general comfort levels of older individuals were measured using the Short Form of the General Comfort Scale. This measurement evaluates components of comfort, including physical ease, emotional comfort, environmental comfort, and social comfort.
Three days after the music intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: yasemin yıldırım, prof.dr., Ege University Faculty of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 837
  • Decision No: 837 (Other Identifier: Izmir Bakırçay University Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be stored for at least 15 years after the completion of the study. All personal and medical information of the participants will remain confidential. Even in the case of publication of the research results, the identity of the individuals will remain anonymous

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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