- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07202182
- Original Trial
Creative Drama-Based Stress Management Program on Stress, Coping, and Emotional Intelligence
The Effect of a Creative Drama-Based Stress Management Program on Stress, Coping, and Emotional Intelligence Levels in Nursing Students
The study was designed with a parallel-group randomized controlled experimental design to determine the effects of a creative drama-based stress management program on the stress, coping, and emotional intelligence levels of nursing students. Nursing students in the experimental group will receive a creative drama-based stress management program for a total of six sessions over three weeks. Students in the active control group will receive three weeks of theoretical training. Students will receive a posttest at the end of the intervention program and a follow-up one month after the intervention.
H0-1: There is no difference between the creative drama and control groups regarding perceived stress level.
H0-2: There is no difference between the creative drama and control groups regarding biopsychosocial response level.
H0-3: There is no difference between the creative drama and control groups regarding stress-coping behaviors.
H0-4: There is no difference between the creative drama and control groups regarding emotional intelligence level.
Study Overview
Status
Intervention / Treatment
Detailed Description
Nursing students will be assigned to the experimental and control groups using a stratified, simple randomization method within the strata. Gender was taken into account to ensure homogeneity between groups. Students will be divided into two strata based on gender (male and female).
To prevent selection bias, data will be collected by an independent expert, and students will be assigned to the experimental and control groups using a randomization method. Participant numbers will be assigned to students when the preliminary assessment data is transferred to the computer. Student group assignment will be conducted by a biostatistician independent of the study.
To prevent reporting bias, the study data will be analyzed by a biostatistician. Because the interventions will be administered by the researcher, there will be no blinding of the investigator. Participant blinding will be achieved by administering the educational experimental to the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey (Türkiye), 06490
- Gazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a nursing student,
- Volunteering to participate in the study,
Exclusion Criteria:
- Having creative drama courses,
- Receiving professional psychological support,
- Having a disease that would prevent participation in the study.
- Participants were also excluded if they did not attend at least two consecutive sessions, or if they were incomplete or did not complete the data collection tools.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Creative Drama Group
A creative drama-based stress management program consisting of a total of 6 sessions, 3 weeks, will be applied to the experimental group.
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A creative drama-based stress management program is an intervention that aims to reduce nursing students' stress levels and increase their coping and emotional intelligence skills.
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Active Comparator: Active Comparator Grup
The active control group will be given 3 weeks of theoretical training.
|
In the study, the control group will receive health education training for three weeks.
This method aims to prevent any loss of motivation that might result from the control group not receiving any training.
It also helps determine whether the effects observed in the experimental group are due solely to the creative drama-based stress management program or to the overall training process.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale for Nursing Students
Time Frame: Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
|
Developed in Chinese by Sheu et al. (2002), the Turkish adaptation was made by Karaca et al. (2015).
The scale consists of 29 items, and a five-point Likert-type scale was used to evaluate the items: "4 - Very stressful for me, 3, 2, 1, 0 - Not stressful for me."
The scale has six subscales.
The total score ranges from 0 to 116.
A higher score indicates a higher degree of stress.
|
Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
|
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Bio-Psycho-Social Response Scale for Nursing Students
Time Frame: Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
|
Developed in Chinese by Sheu et al. (2002), the Turkish adaptation was made by Karaca et al. (2015).
The scale consists of 21 items, and a five-point Likert-type rating scale was used for the assessment of items: 4 - I always experience, 3, 2, 1, and 0 - I never experience.
The scale has three subscales.
A higher score indicates more symptoms and a poorer bio-psycho-social status.
|
Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
|
|
Stress Coping Behaviors Scale for Nursing Students
Time Frame: Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
|
Developed in Chinese by Sheu et al. (2002) and adapted into Turkish by Karaca et al. (2015).
The scale consists of 19 items and was evaluated using a five-point Likert-type scale (4 - Agree, 3, 2, 1, 0 - Strongly Disagree).
The scale has four subscales.
A higher score on each subscale indicates that the student used that coping strategy more frequently.
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Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
|
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Emotional Intelligence Trait Scale - Short Form
Time Frame: Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
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Developed by Petrides and Furnham (2000) to assess an individual's self-perception of their emotional abilities.
Adapted to Turkish by Deniz et al. (2013), the scale consists of a total of 20 items and four subscales: well-being, self-control, emotionality, and sociability.
A high score indicates a high level of emotional intelligence; a low score indicates a low level of emotional intelligence.
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Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (follow-up)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025-1375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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