Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05859893 |
Other study ID # |
EgeTrial3 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 3, 2020 |
Est. completion date |
September 15, 2021 |
Study information
Verified date |
May 2023 |
Source |
Ege University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study investigated the impact of traditional classical Turkish music as a telehealth
intervention on reducing stress and loneliness among elderly individuals.
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.