NCT07560241

Brief Summary

Nursing students face stress during their education, especially when transitioning to clinical practice; poorly managed stress reduces academic achievement and increases levels of depression and anxiety. Therefore, developing students' emotional awareness and coping skills is important. Art therapy is an effective method that supports individuals in self-expression and the development of emotion regulation skills. Although the literature shows positive effects of art-based interventions on psychological well-being, there are limited randomized controlled studies that address depression, anxiety, stress, and emotion regulation skills together in nursing students. Accordingly, this study aims to determine the effect of an intermodal art therapy program on these variables in nursing students. The research was planned as a two-group, single-blind, observational, randomized controlled interventional study. The population of the study will consist of 1st and 2nd-year nursing students studying at Istanbul Atlas University, and 44 students meeting the inclusion-exclusion criteria will constitute the sample of the study. The intermodal art therapy program will be applied to the intervention group. Data; Data will be collected using an Individual Demographic Form, the Depression, Anxiety, Stress Scale, and the Emotion Regulation Skills Scale. Interventions will be administered in approximately grouped sessions, once a week, for a total of 8 sessions, each lasting 90 minutes, in a structured format. Data analysis will be performed using the SPSS 23.0 software package. Descriptive statistics such as frequency distribution, mean, and standard deviation will be used to define the sample size; pairwise pairs or the Wilcoxon pairwise test will be used for intragroup comparisons according to parametric test assumptions; and the Chi-square test will be used for the analysis of categorical data. A 95% significance level will be used to determine differences in the analyses. This study aims to contribute to strengthening the psychosocial care of nursing students by providing evidence on the effectiveness of an intermodal art therapy program applied to nursing students.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress11%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 24, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 29, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Intermodal Art TherapyDepressionAnxietyStressEmotion Regulation SkillNursing Students

Outcome Measures

Primary Outcomes (2)

  • Depression, anxiety, stress

    Depression, Anxiety, Stress Scale (DASS-21) Lovibond and Lovibond (1995) created DASS-21 by shortening DASS-42. Sarıçam (2018) performed psychometric tests on the Turkish version of the "Depression Anxiety Stress-21 Scale (DASS-21)" in normal and clinical samples. In the normal sample, test-retest correlation coefficients were found to be r=0.68 for the depression subscale, r=0.66 for the anxiety subscale, and r=0.61 for the stress subscale. The scale, which is a four-point Likert type, consists of 7 questions each measuring the "depression, stress, and anxiety dimensions". In the depression subscale scores, 0-4 points indicate normal, 5-6 points mild, 7-10 points moderate, 11-13 points advanced, and 14 points and above indicate very advanced depression. In the anxiety subscale, scores between 0-3 indicate normal, 4-5 indicates mild, 6-7 indicates moderate, 8-9 indicates advanced, and 10 and above indicates very advanced anxiety levels. In the stress subscale, scores between 0-7 indic

    Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)

  • Emotion Regulation Skills

    Emotion Regulation Skills Scale (EDS) This is a scale developed by Berking and Znoj (2008) to determine individuals' emotion regulation skills. The adaptation of the scale into Turkish, and its validity and reliability study, were carried out by Vatan and Kâhya (2018). The scale is a self-report instrument consisting of 27 items with a five-point Likert scale (0=almost never, 4=almost always). The Emotional Behavior Test (EBT) encompasses nine sub-dimensions: awareness/attention (e.g., 'I paid attention to my feelings.'), bodily sensations (e.g., 'My physical sensations were a good indicator of how I felt.'), clarity (e.g., 'I was sure of which emotions I was experiencing.'), understanding (e.g., 'I was aware of why I felt that way.'), acceptance (e.g., 'I accepted my emotions.'), tolerance (e.g., 'I felt I could tolerate my negative emotions.'), preparedness for confrontation (e.g., 'Even though it made me feel uncomfortable or anxious, I did what I planned.'), self-support (e.g., 'I

    Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)

Study Arms (2)

Art Therapy Group

EXPERIMENTAL

In the study, it was planned to apply art therapy program the independent variable to the intervention group in 8 sessions of 90-120 minutes, one days a week, and no intervention was planned for the control group.

Behavioral: Art Therapy

Comparison group

NO INTERVENTION

No intervention was planned for the control group.

Interventions

Art TherapyBEHAVIORAL

Intermodal art therapy program

Also known as: Intermodal art therapy
Art Therapy Group

Eligibility Criteria

Age17 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being enrolled in the 1st or 2nd year of the Nursing Department at Istanbul Atlas University in the Spring Semester of 2025-2026,
  • Voluntarily participating in the research

You may not qualify if:

  • Having any comprehension or speech impairment,
  • Having any psychiatric diagnosis,
  • Being on any psychotropic medication,
  • Being enrolled in another program using a similar method that could affect the study's outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Atlas University

Istanbul, Istanbul, 34408, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

April 29, 2026

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

July 18, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

We can share if necessary

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
6 months
Access Criteria
Contacting authors

Locations