Complementary and Alternative TherapiesNCT06843941
The Effect of Music on Sleep Quality and Comfort in Elderly: A Randomized Controlled Trial
A study testing Music intervention in people with Complementary and Alternative Therapies and Aging, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 daysHealthy volunteers can take part
- Conditions the study is for
- Complementary and Alternative Therapies, Aging, Geriatric
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Buca Seyfi Demirsoy Training and Research Hospital
Izmir, Buca
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Music intervention
- Keywords
- music theraphy, comfort, sleep quality, older adults
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
Also called music, complemantary and alternative Therapies
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three days after the music intervention.
Secondary outcomes (1)
Comfort Levels
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.
Measured: Three days after the music intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jan 2023
- Primary completion1 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Complementary and Alternative TherapiesStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derin Köksal, Ege University
- Investigators
- yasemin yıldırım, prof.dr., Study director, Ege University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843941
- Sponsor's protocol ID
- 837
- Other IDs
- Decision No: 837
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Music Therapy. (2020). Applications-Extended information about music research and practice. MusiCure.
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
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.
PubMed 18959456Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.
PubMed 3650169Fredriksson 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.
PubMed 19446459
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Sleep Quality and Comfort Levels in Elderly Individuals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06843941
- Acronym / sponsor ID
- 837
- Keywords
- music theraphy, comfort, sleep quality, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Other: Music interventionFor 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. |
| 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. |
Who may qualify
- Ages
- 65 to 100 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionAlso: music, complemantary and alternative TherapiesIn 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 | Music Group |
Primary outcome
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.
1 secondary outcome
Comfort Levels
Time frame: Three days after the music intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publicationMusic Therapy. (2020). Applications-Extended information about music research and practice. MusiCure.
- Results publicationEje, 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
- Results publication: PubMed 18959456Ziv 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.
- Results publication: PubMed 3650169Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.
- Results publication: PubMed 19446459Fredriksson 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.
- It was used for simple and stratified randomizationLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yasemin yıldırım, prof.dr. study director
Ege University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Complementary and Alternative Therapies and Aging, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Three days after the music intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06843941, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.