- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07116005
- Original Trial
Mandala Art Therapy on Practical Examination Anxiety (Mandala)
The Influence of Mandala Art Therapy on Practical Examination Anxiety Among Undergraduate Nursing Students
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.
Study Overview
Detailed Description
Study Title:
The Influence of Mandala Art Therapy on Practical Examination Anxiety Among Undergraduate Nursing Students
Study Purpose:
The aim of this study was to evaluate the effectiveness of Mandala Art Therapy-a creative, mind-body intervention rooted in complementary and alternative medicine-in reducing practical examination (OSCE) anxiety among undergraduate nursing students. The intervention was implemented as part of a holistic approach to psychological well-being in a randomized, double-blind clinical trial.
Sample Size Determination:
The statistical population included undergraduate nursing students at Near East University. Out of 120 eligible students, 100 participants who met inclusion criteria were enrolled in the study after providing informed consent.
Participants were randomly assigned to either the experimental or control group using a simple randomization technique: 100 numbered cards were placed in a glass container and drawn alternately to assign participants to the two groups.
Based on parameters from a previous similar study (α = 0.05, power = 80%, S1 = 9.61, S2 = 10.4, μ1 = 42.03.5, μ2 = 47.7), the minimum required sample size was 48 per group. To allow for a 5% dropout rate, 50 students were ultimately placed in each group.
A double-blind design was used to reduce bias. The data collector was blinded to group allocations, and the statistician analyzing the data received anonymized variables coded as x1 and x2.
Tools of Data Collection:
A) Demographic Questionnaire:
Collected data on age, gender, marital status, and educational level.
B) Spielberger State-Trait Anxiety Inventory (STAI):
A validated 40-item tool assessing state and trait anxiety using a 4-point Likert scale. Higher scores indicated greater anxiety. The STAI has demonstrated strong psychometric properties, with a Cronbach's alpha of 0.96.
Intervention:
Experimental Group:Students participated in a 20-minute unstructured Mandala coloring session in a quiet room, one hour before the OSCE. Each student was provided with a Mandala outline and six colored pencils. The session aimed to foster mindfulness and reduce pre-exam anxiety.
Control Group:Students followed the standard university OSCE preparation routine without any additional intervention.
Implementation Phase:
The trial was conducted within the Nursing Department of Near East University. All students were briefed about the procedures and gave written informed consent. Mandala sessions were conducted in a distraction-free environment, and all participants completed STAI questionnaires before and after the intervention period.
Ethical Considerations: The study was approved by the Near East University Ethics Review Board (Approval No. NUE/2024/124-1854) and registered on ClinicalTrials.gov (NCT06571357). Ethical standards followed the Declaration of Helsinki (1964). All participants were informed of their right to withdraw at any time. Confidentiality and data protection were strictly maintained.
Statistical Analysis: All statistical analyses were conducted using SPSS version 25. The Kolmogorov-Smirnov test was used to assess normality. Data were analyzed using: Descriptive statistics (mean, SD, frequencies) Paired t-test (within-group pre-post comparison) Independent t-test (between-group comparison) Chi-square test (for categorical variables) A P-value < 0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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KKTC (Turkish Republic Of Northern Cyprus
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Nicosia, KKTC (Turkish Republic Of Northern Cyprus, Cyprus
- Near East University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine Academic Preparation
Participants in this group continue with their usual academic preparation and receive no additional interventions.
|
|
|
Experimental: Mandala Art Therapy
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Practical Exam Anxiety Levels
Time Frame: Anxiety levels are measured at two time points-immediately before and immediately after the intervention session, conducted one hour prior to the OSCE
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pouran Varvani Farahani, PhD, Department of Nursing, Faculty of Health Science, Cyprus International University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PVF2025CAM003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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