Clinical trial NCT05859893: Therapeutic Melodies: How Classical Turkish Music Soothes Stress and Eases Loneliness
Official title: Therapeutic Melodies: How Classical Turkish Music Soothes Stress and Eases Loneliness - A Randomized Controlled Trial With Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Loneliness
COVID-19 Pandemic
Elderly
Keywords: livestream
music
tele-medicine
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The current 4-week randomized, single-blind factorial trial was conducted with a control group and one intervention group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

i. 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.

i. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Perceived Stress Scale (first evaluation with posttest)
timeFrame: Through intervention completion, an average of 1 months
measure: The UCLA Loneliness Scale III (first evaluation with posttest)
timeFrame: Through intervention completion, an average of 1 months
measure: The Perceived Stress Scale (second evaluation with follow up)
timeFrame: Through intervention completion, an average of 3 months
measure: The UCLA Loneliness Scale III (second evaluation with follow up)
timeFrame: Through intervention completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Izmır
country: Turkey
facility: Ege University Faculty of Nursing
Study officials:
References: