The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity

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

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.

Study Overview

• Status: Completed
• Conditions: Psychological Stress; Psychology, Positive; Psychological Well-Being
• Intervention / Treatment: Behavioral: Placebo group practice; Behavioral: Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No attempt was made. Measurement tools were applied simultaneously with the placebo control group and intervention group before, after and during the follow-up.; pretest; final test; Evaluated by follow-up measurements.
Placebo Comparator: Placebo Control Group; A symbolic intervention consisting of six sessions, which was different from the content of the sessions applied to the intervention group, did not have any curative and active content, and was carried out simultaneously with the intervention group as the application time, was applied. Sessions lasted approximately one hour. It was carried out once a week. It was completed in six weeks. In the sessions, the problems faced by nursing students due to distance education during the Covid-19 pandemic, professional difficulties, experiences, and issues related to their professional goals were discussed. The effectiveness of the semi-structured sessions; pretest; symbolic group work; final test; evaluated by follow-up measurements.	Behavioral: Placebo group practice; The placebo control group application was carried out simultaneously with the intervention group application, and the group application without active curative content was applied.
Experimental: Intervention Group; A semi-structured group study consisting of six sessions based on interpersonal relations supported by the designed SIA instrument was applied. Sessions lasted approximately one hour. One session per week was administered. It was completed in six weeks. The initiatives applied in the sessions were implemented based on Peplau's theory of Interpersonal Relations. Group work was supported by the SIA instrument and music therapy techniques were used. In addition, positive psychology and psychological well-being literature were examined in the creation of initiatives. The effectiveness of semi-structured sessions; pretest; group interaction study consisting of six sessions; final test; evaluated by follow-up measurements.	Behavioral: Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice; Group Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Psychological Well-Being Scale" scores	Decreased "Psychological Well-Being Scale" scores of intervention group in post test and follow-up measurements after SİA instrument supported interpersonal relations-based group practice	A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group
"Creative Scale" scores	Decreased "Creative Scale" scores of intervention group in post test and follow-up measurements after SİA instrument supported interpersonal relations-based group practice	A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Director: Ayşegül DÖNMEZ, Prof. Dr., Ege University Faculty of Nursing; Principal Investigator: Derya KÜLİĞ ATABEY, PhD, Ege University Hospital (Application and Research Center)

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): December 17, 2022
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: psychological well-being; creativity; psychiatric nursing; interpersonal relations theory
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: EGE-ATABEY-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No