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

Primary Purpose

Psychological Stress, Psychology, Positive, Psychological Well-Being

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice
Placebo group practice
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Stress focused on measuring interpersonal relations theory, psychological well-being, psychiatric nursing, creativity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

Control Group

Placebo Control Group

Intervention Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

"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
"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

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
May 23, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05869006
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
December 17, 2022 (Actual)
Study Completion Date
March 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Psychology, Positive, Psychological Well-Being
Keywords
interpersonal relations theory, psychological well-being, psychiatric nursing, creativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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).
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Placebo Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice
Intervention Description
Group Practice
Intervention Type
Behavioral
Intervention Name(s)
Placebo group practice
Intervention Description
The placebo control group application was carried out simultaneously with the intervention group application, and the group application without active curative content was applied.
Primary Outcome Measure Information:
Title
"Psychological Well-Being Scale" scores
Description
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
Time Frame
A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group
Title
"Creative Scale" scores
Description
Decreased "Creative Scale" scores of intervention group in post test and follow-up measurements after SİA instrument supported interpersonal relations-based group practice
Time Frame
A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşegül DÖNMEZ, Prof. Dr.
Organizational Affiliation
Ege University Faculty of Nursing
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Derya KÜLİĞ ATABEY, PhD
Organizational Affiliation
Ege University Hospital (Application and Research Center)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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