NCT05869006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

May 4, 2023

Last Update Submit

May 23, 2023

Conditions

Keywords

interpersonal relations theorypsychological well-beingpsychiatric nursingcreativity

Outcome Measures

Primary Outcomes (2)

  • "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

Study Arms (3)

Control Group

NO INTERVENTION

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 Control Group

PLACEBO COMPARATOR

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

Intervention Group

EXPERIMENTAL

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

Interventions

The placebo control group application was carried out simultaneously with the intervention group application, and the group application without active curative content was applied.

Placebo Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Ayşegül DÖNMEZ, Prof. Dr.

    Ege University Faculty of Nursing

    STUDY DIRECTOR
  • Derya KÜLİĞ ATABEY, PhD

    Ege University Hospital (Application and Research Center)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 22, 2023

Study Start

October 12, 2021

Primary Completion

December 17, 2022

Study Completion

March 17, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations