StressNCT05859893
Therapeutic Melodies: How Classical Turkish Music Soothes Stress and Eases Loneliness
A study testing Classical Turkish Music Sessions in people with Stress and Loneliness, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the impact of traditional classical Turkish music as a telehealth intervention on reducing stress and loneliness among elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Loneliness, COVID-19 Pandemic
- What is being tested?
- Classical Turkish Music Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2020to 15 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Registered for and attending their first years of lectures
- Aged higher than 65 year
- Able to use an interactive social media application via a computer, mobile phone or other electronic devices
- Participate willingly and voluntarily in the research.
Who cannot join
- Have a physical or sensory impairment that would affect the ability to listen to music (e.g., history of temporal brain damage, limb loss, hearing loss, etc.),
- Have a psychiatric diagnosis that would affect decision-making and orientation assessment abilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Nursing
Izmır, 35040
About this study
Official title: Therapeutic Melodies: How Classical Turkish Music Soothes Stress and Eases Loneliness - A Randomized Controlled Trial With Elders
This study investigated the impact of traditional classical Turkish music as a telehealth intervention on reducing stress and loneliness among elderly individuals.
Read the detailed description
The study was conducted at one of the Third Age University as a single-blind randomized and control-group experimental study. Elders were randomized into two main groups according to whether they lived alone or with someone. Interactive livestream musical interventions were performed for four weeks, in total eight sessions. The data of the study were collected three times with the Perceived Stress Scale and UCLA Loneliness Scale III in a pretest-posttest-follow-up test design (12th week after the posttest). Significance of difference tests, repeated variance analyses, and strength of influence tests were performed in dependent and independent groups with and without normal distribution.
The online-tool randomization method was utilized to apply simple randomization. Upon identifying the sample, it was initially segregated into two categories: individuals who resided alone and those who did not. The grouping of participants was carried out using an assignment method through a computer program, ensuring equivalence among research groups in terms of gender, stress, and loneliness. Following randomization, conformity of the groups' homogeneity and scales scores to normal distribution were examined with the Shapiro-Wilk test, skewness and kurtosis coefficients, histograms, and Levene's test of homogeneity of variance (p<0,05)
The study aimed to investigate the short and long-term effects of eight sessions of interactive livestreamed classic Turkish music performances on stress and loneliness during Covid-19 pandemic in elderly aged 65 and over who experiencing home isolation. The research hypotheses are as follows:
Perceived stress:
Hypothesis I, H1: Interactive livestream classical Turkish music sessions have a reducing effect on the mean scores of the Perceived Stress Scale.
- There is a significant difference in the mean scores of the Perceived Stress Scale among intervention groups over time (pre-test, post-test, follow-up). ii. There is a significant difference in the mean scores of the Perceived Stress Scale between intervention and control groups after the intervention in favor of the intervention group.
Loneliness:
Hypothesis II, H1: Interactive livestream classical Turkish music sessions have a reducing effect on the mean scores of the UCLA Loneliness Scale - III.
- There is a significant difference in the mean scores of the UCLA Loneliness Scale - III among intervention groups over time (pre-test, post-test, follow-up). ii. There is a significant difference in the mean scores of the UCLA Loneliness Scale - III between intervention and control groups after the intervention in favor of the intervention group.
For repeated measurements of score averages at different times within the same group, the homogeneity of variances was tested using the Levene Variance Homogeneity Assumption and Mauchly's Sphericity Assumption within the scope of Repeated Measures Analysis of Variance. When homogeneity could not be demonstrated, the Greenhouse-Geisser F value was used. For the control group with two-time measurements, the parametric repeated t-Test (Paired Samples t-Test) was used, assuming normal distribution.
To examine the significance of the difference in independent groups (intervention - control / intergroup) for repeated measurements at different times in assessing the effect size of the intervention, two-way repeated measures ANOVA (factorial ANOVA) was used. Since Mauchly's Sphericity Assumption was not met, the Greenhouse-Geisser F value was used, although the distribution was normal.
In the study, where the statistical significance level was accepted as p<0.05, effect size evaluations were made to test the statistical significance and confirm the practical applicability (in real conditions) of the findings. The effect size of the intervention was examined using partial eta squared (ηp2).
The data collection process was conducted thrice as pretest, posttest, and follow-up. The posttest was performed immediately after the completion of the 4-week intervention, whereas the follow-up measurements were obtained 12 weeks later. To apprise the volunteers about their respective groups and elucidate the application procedure, mobile appointments and virtual meetings were arranged.
- Conditions
- Stress, Loneliness, COVID-19 Pandemic, Elderly
- Being tested
- Classical Turkish Music Sessions
- Keywords
- livestream, music, tele-medicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical Turkish Music SessionsBehavioural
The participants attended an interactive livestreamed music performance. In selecting the mode, tempo, and songs to be performed, recommendations were obtained from the Applied Music Therapies Association, and the pieces with copyrighted recordings presented by the Edirne State Turkish Music Ensemble, under the leadership of the General Directorate of Fine Arts of the Ministry of Culture and Tourism. As part of the project, examples of traditional Turkish songs were presented to the elderly. The recommended genres and songs consist of vocal and instrumental works belonging to major and minor scales from the Classical Period, which spans from the 14th to the 20th century. In this respect an assembly of eight-musican consisting of five artists playing kanun, tanbur, ney, classical kemençe, and bendir, as well as two vocal soloists performed.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Control | No intervention | Not described |
| Intervention | Experimental | Behavioral: Interactive livestreamed classical Turkish music sessions with a professional music band.
The sessions, which lasted approximately one and a half hours, twice a week, have been completed within one month. Receives: Behavioral: Classical Turkish Music Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Perceived Stress Scale (first evaluation with posttest)
Scale was developed by Cohen, Kamarck, and Mermelstein (1983), and adapted to Turkish culture by Eskin et al. (2013) to determine the potential effects of sample stress and loneliness perception on sociodemographic and musical tendencies. According to the psychometric adaptation study, criterion validity was ensured, with an internal consistency value of .84 and a test-retest reliability of .87. The scale, which consists of 14 items, is interpreted based on the total score and two sub-dimensions (Inadequate self-efficacy perception-ISPE and stress-discomfort perception-SDP). A high total score indicates a high perception of stress, inadequate coping strategies, and ineffective stress management. In this study, the Cronbach's alpha coefficient of the scale was 0.82.
Measured: Through intervention completion, an average of 1 months
The UCLA Loneliness Scale III (first evaluation with posttest)
Scale is a widely used tool for assessing loneliness, which was developed by Russell et al. (1978). The psychometric properties of the UCLA Loneliness Scale III (UCLA-III) in Turkish culture were first investigated by Demir (1989). In this study, the 3rd revision of the scale developed by Durak and Senol Durak (2010) for Turkish culture was used. The scale consists of 20 items and is rated on a four-point Likert scale (1: Never - 4: Always). The total score ranges from 20 to 80, with higher scores indicating greater loneliness. In similar sample groups, the Cronbach's alpha coefficient of the scale was found to be 0.91, indicating high psychometric suitability (Kurt 2014). In the context of this study, the Chronbach's alpha coefficient of the scale is 0.93.
Measured: Through intervention completion, an average of 1 months
The Perceived Stress Scale (second evaluation with follow up)
Scale was developed by Cohen, Kamarck, and Mermelstein (1983), and adapted to Turkish culture by Eskin et al. (2013) to determine the potential effects of sample stress and loneliness perception on sociodemographic and musical tendencies. According to the psychometric adaptation study, criterion validity was ensured, with an internal consistency value of .84 and a test-retest reliability of .87. The scale, which consists of 14 items, is interpreted based on the total score and two sub-dimensions (Inadequate self-efficacy perception-ISPE and stress-discomfort perception-SDP). A high total score indicates a high perception of stress, inadequate coping strategies, and ineffective stress management. In this study, the Cronbach's alpha coefficient of the scale was 0.82.
Measured: Through intervention completion, an average of 3 months
The UCLA Loneliness Scale III (second evaluation with follow up)
Scale is a widely used tool for assessing loneliness, which was developed by Russell et al. (1978). The psychometric properties of the UCLA Loneliness Scale III (UCLA-III) in Turkish culture were first investigated by Demir (1989). In this study, the 3rd revision of the scale developed by Durak and Senol Durak (2010) for Turkish culture was used. The scale consists of 20 items and is rated on a four-point Likert scale (1: Never - 4: Always). The total score ranges from 20 to 80, with higher scores indicating greater loneliness. In similar sample groups, the Cronbach's alpha coefficient of the scale was found to be 0.91, indicating high psychometric suitability (Kurt 2014). In the context of this study, the Chronbach's alpha coefficient of the scale is 0.93.
Measured: Through intervention completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start3 Jun 2020
- Primary completion24 Jul 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The current 4-week randomized, single-blind factorial trial was conducted with a control group and one intervention group.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Beycan Ekitli, PhD., Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859893
- Sponsor's protocol ID
- EgeTrial3
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public data sharing is applicable to this article. It is planned to publish the research results in a high-impact journal in the field.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Melodies: How Classical Turkish Music Soothes Stress and Eases Loneliness - A Randomized Controlled Trial With Elders
- ClinicalTrials.gov ID
- NCT05859893
- Acronym / sponsor ID
- EgeTrial3
- Conditions
- Stress, Loneliness, COVID-19 Pandemic, Elderly
- Keywords
- livestream, music, tele-medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 16 May 2023 (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.
This study investigated the impact of traditional classical Turkish music as a telehealth intervention on reducing stress and loneliness among elderly individuals.
Detailed description
The study was conducted at one of the Third Age University as a single-blind randomized and control-group experimental study. Elders were randomized into two main groups according to whether they lived alone or with someone. Interactive livestream musical interventions were performed for four weeks, in total eight sessions. The data of the study were collected three times with the Perceived Stress Scale and UCLA Loneliness Scale III in a pretest-posttest-follow-up test design (12th week after the posttest). Significance of difference tests, repeated variance analyses, and strength of influence tests were performed in dependent and independent groups with and without normal distribution.
The online-tool randomization method was utilized to apply simple randomization. Upon identifying the sample, it was initially segregated into two categories: individuals who resided alone and those who did not. The grouping of participants was carried out using an assignment method through a computer program, ensuring equivalence among research groups in terms of gender, stress, and loneliness. Following randomization, conformity of the groups' homogeneity and scales scores to normal distribution were examined with the Shapiro-Wilk test, skewness and kurtosis coefficients, histograms, and Levene's test of homogeneity of variance (p<0,05)
The study aimed to investigate the short and long-term effects of eight sessions of interactive livestreamed classic Turkish music performances on stress and loneliness during Covid-19 pandemic in elderly aged 65 and over who experiencing home isolation. The research hypotheses are as follows:
Perceived stress:
Hypothesis I, H1: Interactive livestream classical Turkish music sessions have a reducing effect on the mean scores of the Perceived Stress Scale.
- There is a significant difference in the mean scores of the Perceived Stress Scale among intervention groups over time (pre-test, post-test, follow-up). ii. There is a significant difference in the mean scores of the Perceived Stress Scale between intervention and control groups after the intervention in favor of the intervention group.
Loneliness:
Hypothesis II, H1: Interactive livestream classical Turkish music sessions have a reducing effect on the mean scores of the UCLA Loneliness Scale - III.
- There is a significant difference in the mean scores of the UCLA Loneliness Scale - III among intervention groups over time (pre-test, post-test, follow-up). ii. There is a significant difference in the mean scores of the UCLA Loneliness Scale - III between intervention and control groups after the intervention in favor of the intervention group.
For repeated measurements of score averages at different times within the same group, the homogeneity of variances was tested using the Levene Variance Homogeneity Assumption and Mauchly's Sphericity Assumption within the scope of Repeated Measures Analysis of Variance. When homogeneity could not be demonstrated, the Greenhouse-Geisser F value was used. For the control group with two-time measurements, the parametric repeated t-Test (Paired Samples t-Test) was used, assuming normal distribution.
To examine the significance of the difference in independent groups (intervention - control / intergroup) for repeated measurements at different times in assessing the effect size of the intervention, two-way repeated measures ANOVA (factorial ANOVA) was used. Since Mauchly's Sphericity Assumption was not met, the Greenhouse-Geisser F value was used, although the distribution was normal.
In the study, where the statistical significance level was accepted as p<0.05, effect size evaluations were made to test the statistical significance and confirm the practical applicability (in real conditions) of the findings. The effect size of the intervention was examined using partial eta squared (ηp2).
The data collection process was conducted thrice as pretest, posttest, and follow-up. The posttest was performed immediately after the completion of the 4-week intervention, whereas the follow-up measurements were obtained 12 weeks later. To apprise the volunteers about their respective groups and elucidate the application procedure, mobile appointments and virtual meetings were arranged.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The current 4-week randomized, single-blind factorial trial was conducted with a control group and one intervention group.
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control | No intervention | – |
| Intervention | Experimental | Behavioral: Classical Turkish Music SessionsBehavioral: Interactive livestreamed classical Turkish music sessions with a professional music band. The sessions, which lasted approximately one and a half hours, twice a week, have been completed within one month. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Registered for and attending their first years of lectures
- Aged higher than 65 year
- Able to use an interactive social media application via a computer, mobile phone or other electronic devices
- Participate willingly and voluntarily in the research.
Key exclusion criteria (2 listed)
- Have a physical or sensory impairment that would affect the ability to listen to music (e.g., history of temporal brain damage, limb loss, hearing loss, etc.),
- Have a psychiatric diagnosis that would affect decision-making and orientation assessment abilities
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 |
|---|---|---|
| Classical Turkish Music SessionsThe participants attended an interactive livestreamed music performance. In selecting the mode, tempo, and songs to be performed, recommendations were obtained from the Applied Music Therapies Association, and the pieces with copyrighted recordings presented by the Edirne State Turkish Music Ensemble, under the leadership of the General Directorate of Fine Arts of the Ministry of Culture and Tourism. As part of the project, examples of traditional Turkish songs were presented to the elderly. The recommended genres and songs consist of vocal and instrumental works belonging to major and minor scales from the Classical Period, which spans from the 14th to the 20th century. In this respect an assembly of eight-musican consisting of five artists playing kanun, tanbur, ney, classical kemençe, and bendir, as well as two vocal soloists performed. | Behavioural | Intervention |
Primary outcome
The Perceived Stress Scale (first evaluation with posttest)
Time frame: Through intervention completion, an average of 1 months
Scale was developed by Cohen, Kamarck, and Mermelstein (1983), and adapted to Turkish culture by Eskin et al. (2013) to determine the potential effects of sample stress and loneliness perception on sociodemographic and musical tendencies. According to the psychometric adaptation study, criterion validity was ensured, with an internal consistency value of .84 and a test-retest reliability of .87. The scale, which consists of 14 items, is interpreted based on the total score and two sub-dimensions (Inadequate self-efficacy perception-ISPE and stress-discomfort perception-SDP). A high total score indicates a high perception of stress, inadequate coping strategies, and ineffective stress management. In this study, the Cronbach's alpha coefficient of the scale was 0.82.
The UCLA Loneliness Scale III (first evaluation with posttest)
Time frame: Through intervention completion, an average of 1 months
Scale is a widely used tool for assessing loneliness, which was developed by Russell et al. (1978). The psychometric properties of the UCLA Loneliness Scale III (UCLA-III) in Turkish culture were first investigated by Demir (1989). In this study, the 3rd revision of the scale developed by Durak and Senol Durak (2010) for Turkish culture was used. The scale consists of 20 items and is rated on a four-point Likert scale (1: Never - 4: Always). The total score ranges from 20 to 80, with higher scores indicating greater loneliness. In similar sample groups, the Cronbach's alpha coefficient of the scale was found to be 0.91, indicating high psychometric suitability (Kurt 2014). In the context of this study, the Chronbach's alpha coefficient of the scale is 0.93.
The Perceived Stress Scale (second evaluation with follow up)
Time frame: Through intervention completion, an average of 3 months
Scale was developed by Cohen, Kamarck, and Mermelstein (1983), and adapted to Turkish culture by Eskin et al. (2013) to determine the potential effects of sample stress and loneliness perception on sociodemographic and musical tendencies. According to the psychometric adaptation study, criterion validity was ensured, with an internal consistency value of .84 and a test-retest reliability of .87. The scale, which consists of 14 items, is interpreted based on the total score and two sub-dimensions (Inadequate self-efficacy perception-ISPE and stress-discomfort perception-SDP). A high total score indicates a high perception of stress, inadequate coping strategies, and ineffective stress management. In this study, the Cronbach's alpha coefficient of the scale was 0.82.
The UCLA Loneliness Scale III (second evaluation with follow up)
Time frame: Through intervention completion, an average of 3 months
Scale is a widely used tool for assessing loneliness, which was developed by Russell et al. (1978). The psychometric properties of the UCLA Loneliness Scale III (UCLA-III) in Turkish culture were first investigated by Demir (1989). In this study, the 3rd revision of the scale developed by Durak and Senol Durak (2010) for Turkish culture was used. The scale consists of 20 items and is rated on a four-point Likert scale (1: Never - 4: Always). The total score ranges from 20 to 80, with higher scores indicating greater loneliness. In similar sample groups, the Cronbach's alpha coefficient of the scale was found to be 0.91, indicating high psychometric suitability (Kurt 2014). In the context of this study, the Chronbach's alpha coefficient of the scale is 0.93.
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 16 May 2023.
- Individual participant dataSharing planned: Yes. Public data sharing is applicable to this article. It is planned to publish the research results in a high-impact journal in the field.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Turkish Music Sessions in people with Stress and Loneliness, 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 4 inclusion and 2 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 16 May 2023. 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?
The Perceived Stress Scale (first evaluation with posttest) (time frame: Through intervention completion, an average of 1 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2023.