Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05869006 |
| Other study ID # |
EGE-ATABEY-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 12, 2021 |
| Est. completion date |
March 17, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Ege University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this interventional study is to examine the effect of group practice based on
interpersonal relations supported by the designed SIA instrument on psychological well-being
and creativity.The main questions it aims to answer are:
- Is group practice based on interpersonal relations supported by the designed SIA
instrument effective in increasing the psychological well-being levels of individuals?
- Is group practice based on interpersonal relations supported by the designed SIA
instrument effective in increasing the creativity levels of individuals? Group study
consisting of 6 sessions was applied to the participants. Sessions were administered
once a week. It took six weeks. The effect of group practice based on interpersonal
relations, supported by the designed SIA instrument, on individuals' psychological
well-being and creativity levels was investigated.
Description:
This research was carried out to examine the effect of group practice based on interpersonal
relations supported by the designed SIA instrument on psychological well-being and
creativity.
In a single-blind randomized controlled trial, a 3x4 split-plot design was used. The sample
group was determined in two stages. The target group consisted of those who had scores lower
than the mean scores of the Psychological Well-Being Scale (PWS) total score obtained from
the nursing students who accepted to participate in the study. A stratified randomization was
carried out according to gender with 30 students who met the criteria for inclusion in the
sample from the determined target group. The study was conducted with a total of 30 students,
10 of whom were in the intervention group, 10 in the placebo control group, and 10 in the
control group. Research data were collected with Descriptive Information Form, Psychological
Well-Being Scale (PWS) and Creativity Scale (CS). A group application based on Peplau's
Interpersonal Relations Theory, supported by the SIA instrument, was applied to the
individuals in the intervention group. It is a rhythm instrument with a water effect sound,
designed by SIA researchers and has a national utility model registration certificate. Music
therapy techniques were also used in practice. The application was completed in a total of
six weeks, one session per week. The placebo control group application was carried out
simultaneously with the intervention group application, and the group application without
active curative content was applied. No intervention was applied to the control group. In
order to evaluate the data, PWS and SR were applied at time series points (pretest, posttest,
1st month follow-up and 3rd month follow-up).
In the analysis of the data, Descriptive statistics, Normal distribution of the data related
to continuous variables were evaluated with the Shapiro Wilk test of normality. One-way
analysis of variance (ANOVA) or Kruskal-Wallis H test was used to compare the variances of
more than two independent groups when the assumption of normality of continuous variables was
met. Repeated measures ANOVA (repeated measure ANOVA) was used when the assumption of
normality was provided in the in-group and between-group comparisons for repeated measures.
In the absence of normality, the nonparametric test (Nonparametric Tests for the F1-LD-F1
Design) was used for repeated measurements. In cases where the group*time interaction was
significant, evaluations independent of the time effect were made and repeated measures ANOVA
and Friedman tests were used. A value of p<0.05 was considered statistically significant.
