跳至主要内容
临床试验/NCT05869006
NCT05869006已完成不适用

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

Ege University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2021年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
"Psychological Well-Being Scale" scores

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

"Psychological Well-Being Scale" scores

时间窗: A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group

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

时间窗: A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group

Decreased "Creative Scale" scores of intervention group in post test and follow-up measurements after SİA instrument supported interpersonal relations-based group practice

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derya Küliğ Atabey

PhD

Ege University

研究点 (2)

Loading locations...

相似试验