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

NCT06843941 | Completed

• 2 other identifiers: 837Decision No: 837
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complementary and Alternative Therapies; Aging; Geriatric; Sleep Disorder in Elderly

Keywords

music theraphy; comfort; sleep quality; older adults

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  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 Outcomes (1)

• Comfort Levels

  Three days after the music intervention

Study Arms (2)

Music Group

EXPERIMENTAL

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.

Other: Music intervention

Control Group

NO INTERVENTION

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.

Interventions

Music intervention OTHER

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.

Also known as: music, complemantary and alternative Therapies

Music Group

Eligibility Criteria

• Age: 65 Days - 100 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Buca Seyfi Demirsoy Training and Research Hospital

Izmir, buca, Turkey (Türkiye)

Location

Related Publications (5)

• Music Therapy. (2020). Applications-Extended information about music research and practice. MusiCure.

  BACKGROUND

• Eje, I. (2020). MusiCure®: A therapeutic music selection developed to promote physical and mental relaxation in hospital environments, using a 60-80 bpm range. Retrieved from https://www.musicurestream.com

  BACKGROUND

• Ziv N, Rotem T, Arnon Z, Haimov I. The effect of music relaxation versus progressive muscular relaxation on insomnia in older people and their relationship to personality traits. J Music Ther. 2008 Fall;45(3):360-80. doi: 10.1093/jmt/45.3.360.

  PMID: 18959456 BACKGROUND

• Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.

  PMID: 3650169 BACKGROUND

• Fredriksson AC, Hellstrom L, Nilsson U. Patients' perception of music versus ordinary sound in a postanaesthesia care unit: a randomised crossover trial. Intensive Crit Care Nurs. 2009 Aug;25(4):208-13. doi: 10.1016/j.iccn.2009.04.002. Epub 2009 May 14.

  PMID: 19446459 BACKGROUND

Related Links

• It was used for simple and stratified randomization

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Music Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• yasemin yıldırım, prof.dr.

  Ege University Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 25, 2025
• Study Start: January 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: April 30, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)