Clinical trial NCT06843941: The Effect of Music on Sleep Quality and Comfort in Elderly: a Randomized Controlled Trial
Official title: The Effect of Music on Sleep Quality and Comfort Levels in Elderly Individuals: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complementary and Alternative Therapies
Aging
Geriatric
Sleep Disorder in Elderly
Keywords: music theraphy
comfort
sleep quality
older adults
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Quality
timeFrame: Three days after the music intervention.
Secondary outcomes:
measure: Comfort Levels
timeFrame: Three days after the music intervention
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Buca Seyfi Demirsoy Training and Research Hospital
state: Buca
Study officials:
affiliation: Ege University Faculty of Nursing
name: yasemin yıldırım, prof.dr.
role: STUDY_DIRECTOR
References:
citation: Music Therapy. (2020). Applications-Extended information about music research and practice. MusiCure.
citation: 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
citation: 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.
citation: Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.
citation: 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.