Clinical trial NCT05869006: The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity
Official title: The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity: A Randomized, Single-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Psychology, Positive
Psychological Well-Being
Keywords: interpersonal relations theory
psychological well-being
psychiatric nursing
creativity
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: In a single-blind randomized controlled study, 3X4 split-plot design was used. 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 research 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. In order to evaluate the data, Psychological Well-Being Scale (PWS) and Creativity Scale (CS) were applied at time series points (pretest, posttest, 1st month follow-up and 3rd month follow-up).
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old,
* Agreeing to participate in the research and volunteering to go to the rhythm guitar featured group practice.
* Being in the second or third grade.
* To have a lower score than the PWS total score limits (X=356.52) obtained from all students in the sample pool.

Exclusion Criteria:

* Presence of obstruction in the sense organs

  * Having a self-reported mental illness diagnosis
  * Individuals included in the initiative group do not attend two or more sessions

Primary outcomes:
measure: "Psychological Well-Being Scale" scores
timeFrame: A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group
measure: "Creative Scale" scores
timeFrame: A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University Faculty of Nursing
name: Ayşegül DÖNMEZ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Ege University Hospital (Application and Research Center)
name: Derya KÜLİĞ ATABEY, PhD
role: PRINCIPAL_INVESTIGATOR
References: