NCT07116005

Brief Summary

This randomized clinical trial aimed to evaluate the effectiveness of Mandala Art Therapy in reducing practical examination anxiety among undergraduate nursing students. The primary goal was to determine whether a brief Mandala coloring session prior to the Objective Structured Clinical Examination (OSCE) could significantly reduce students' state anxiety. The study focused on the therapeutic potential of this low-cost, non-invasive, and easily implemented intervention in academic settings. The main research questions guiding the study were: Does Mandala coloring reduce pre-examination anxiety among undergraduate nursing students? Can Mandala Art Therapy be considered a feasible and effective complementary strategy for managing academic stress in clinical evaluation contexts? To address these questions, participants were randomly assigned to either an experimental group, which engaged in a 20-minute Mandala coloring session before the OSCE, or a control group, which received no intervention beyond standard exam preparation. Pre- and post-intervention anxiety levels were measured using the Spielberger State-Trait Anxiety Inventory (STAI) to assess the impact of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

29 days

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

Art TherapyExam AnxietyComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Practical Exam Anxiety Levels

    The primary outcome measure assesses changes in anxiety levels related to the Objective Structured Clinical Examination (OSCE) among undergraduate nursing students. Anxiety is measured using the State-Trait Anxiety Inventory (STAI), a validated psychological instrument that evaluates both situational (state) and general (trait) anxiety. The STAI comprises two subscales with 20 items each, rated on a 4-point Likert scale. Higher total scores indicate greater levels of anxiety.

    Anxiety levels are measured at two time points-immediately before and immediately after the intervention session, conducted one hour prior to the OSCE

Study Arms (2)

Mandala Art Therapy

EXPERIMENTAL

Behavioral: Mandala Coloring Participants in this group receive the Mandala Art Therapy intervention, which involves a 20-minute session of free-form Mandala coloring conducted one hour prior to their Objective Structured Clinical Examination (OSCE). The intervention is designed to reduce exam-related anxiety by promoting mindfulness, visual focus, and emotional self-regulation through creative expression.

Behavioral: Mandala Coloring

Routine Academic Preparation

NO INTERVENTION

Participants in this group continue with their usual academic preparation and receive no additional interventions.

Interventions

Participants in this group receive the Mandala Art Therapy intervention, a creative, mindfulness-based activity rooted in complementary and alternative medicine. The intervention is designed to reduce exam-related anxiety by fostering visual focus, emotional calm, and self-expression. The Mandala protocol includes the following components: * Distribution of printed Mandala outlines on A4 paper * Provision of six colored pencils (red, orange, yellow, green, blue, and purple) * A 20-minute individual coloring session in a quiet and relaxed setting * No prescribed patterns-participants color freely to encourage self-directed engagement The Mandala coloring session is conducted exactly one hour before the Objective Structured Clinical Examination (OSCE). The activity is supervised by the researcher to ensure a supportive and distraction-free environment. Participants are encouraged to concentrate on the process of coloring to promote psychological grounding and reduce pre-exam stress.

Mandala Art Therapy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All students, both female and male, first semester of bachelor's degree, studying in nursing department of Near East University.
  • Not using other stress reduction methods including progressive muscle relaxation, drug therapy, etc. to control exam anxiety.
  • Those willing to participate in the project.

You may not qualify if:

  • Unwilling to continue cooperation in the project,
  • Using any psycho medicines (anti-depressants ...), mental health
  • Mourning, especially the death of loved ones or relatives in the 1st phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University

Nicosia, KKTC (Turkish Republic of Northern Cyprus, Cyprus

Location

Study Officials

  • Pouran Varvani Farahani, PhD

    Department of Nursing, Faculty of Health Science, Cyprus International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-Blind (Investigator, Outcomes Assessor): To minimize bias, a double-blind approach is employed. The data are collected by the researcher, who remains unaware of group assignments, and the statistician performing the analysis is also blinded to the allocation. The data are analyzed as anonymous variables (x# and x#) to preserve objectivity
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants in this clinical trial were randomly assigned to one of two groups: an experimental group that participated in Mandala Art Therapy (coloring a Mandala design for 20 minutes prior to the OSCE), and a control group that received standard academic preparation without any additional intervention. Both groups were observed in parallel throughout the study period to assess changes in exam anxiety levels.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Pediatric Nursing, Near East University , Faculty of Nursing, Nicosia, TRNC

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

May 1, 2024

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available to other researchers

Locations