Psychological StressNCT05869006
The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity
A study testing Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice in people with Psychological Stress and Psychology, Positive, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Psychology, Positive, Psychological Well-Being
- What is being tested?
- Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2021to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice, Placebo group practice
- Keywords
- interpersonal relations theory, psychological well-being, psychiatric nursing, creativity
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Designed SIA Instrument Supported Interpersonal Relations-Based Group PracticeBehavioural
Group Practice
Placebo group practiceBehavioural
The placebo control group application was carried out simultaneously with the intervention group application, and the group application without active curative content was applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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
Measured: 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
Measured: A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start12 Oct 2021
- Primary completion17 Dec 2022
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Küliğ Atabey, Ege University
- Investigators
- Ayşegül DÖNMEZ, Prof. Dr., Study director, Ege University Faculty of NursingDerya KÜLİĞ ATABEY, PhD, Principal investigator, Ege University Hospital (Application and Research Center)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869006
- Sponsor's protocol ID
- EGE-ATABEY-001
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05869006
- Acronym / sponsor ID
- EGE-ATABEY-001
- Keywords
- interpersonal relations theory, psychological well-being, psychiatric nursing, creativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Placebo group practiceA 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. |
| Intervention Group | Experimental | Behavioral: Designed SIA Instrument Supported Interpersonal Relations-Based Group PracticeA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of obstruction in the sense organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Designed SIA Instrument Supported Interpersonal Relations-Based Group PracticeGroup Practice | Behavioural | Intervention Group |
| Placebo group practiceThe placebo control group application was carried out simultaneously with the intervention group application, and the group application without active curative content was applied. | Behavioural | Placebo Control Group |
Primary outcome
"Psychological Well-Being Scale" scores
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşegül DÖNMEZ, Prof. Dr. study director
Ege University Faculty of Nursing
Derya KÜLİĞ ATABEY, PhD principal investigator
Ege University Hospital (Application and Research Center)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice in people with Psychological Stress and Psychology, Positive, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Psychological Well-Being Scale" scores (time frame: A total of five months of designed SIA instrument supported interpersonal relations-based group practice for intervention group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.