Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
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.
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:
NCT07116005
Study Brief:
Protocol Section:
NCT07116005