NCT07202182

Brief Summary

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 intervention 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 (3 weeks), a first follow-up one month after the intervention, and a second follow-up three months later. H0-1: There is no difference in perceived stress levels between the intervention group that underwent the creative drama intervention and the control group. H0-2: There is no difference in biopsychosocial response levels between the intervention group that underwent the creative drama intervention and the control group. H0-3: There is no difference in stress coping levels between the intervention group that underwent the creative drama initiative and the control group. H0-4: There is no difference in emotional intelligence levels between the intervention group that underwent the creative drama initiative and the control group.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

September 23, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 26, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

19 days

First QC Date

September 23, 2025

Last Update Submit

October 1, 2025

Conditions

Keywords

Perceived StressCoping with StressEmotional Intelligencenursing students

Outcome Measures

Primary Outcomes (4)

  • Perceived Stress Scale for Nursing Students

    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 (1st follow-up) 3 months after the intervention (2nd follow-up)

  • Bio-Psycho-Social Response Scale for Nursing Students

    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 (1st follow-up) 3 months after the intervention (2nd follow-up)

  • Stress Coping Behaviors Scale for Nursing Students

    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.

    Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (1st follow-up) 3 months after the intervention (2nd follow-up)

  • Emotional Intelligence Trait Scale - Short Form

    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.

    Pre-intervention (pre-test) Immediately after the intervention (post-test) 1 month after the intervention (1st follow-up) 3 months after the intervention (2nd follow-up)

Study Arms (2)

Creative Drama Group

EXPERIMENTAL

A creative drama-based stress management program consisting of a total of 6 sessions, 3 weeks, will be applied to the experimental group.

Behavioral: Creative Drama-Based Stress Management Program

Active Comparator Grup

ACTIVE COMPARATOR

The active control group will be given 3 weeks of theoretical training.

Behavioral: Training

Interventions

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.

Creative Drama Group
TrainingBEHAVIORAL

In the study, the control group will receive training on a topic different from the experimental intervention 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.

Active Comparator Grup

Eligibility Criteria

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

You may qualify if:

  • Being a nursing student,
  • Volunteering to participate in the study,
  • Scoring high on the Perceived Stress Scale for Nursing Students

You may not qualify if:

  • Taking a creative drama course,
  • Receiving professional psychological support,
  • Having an illness that would prevent participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Sultan AYAZ ALKAYA, Prof. Dr.

CONTACT

Neslihan KÖSE KABAKCIOĞLU, M.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized trial with experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr., Faculty of nursing

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

September 26, 2025

Primary Completion

October 15, 2025

Study Completion

January 15, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations