Description Module

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.

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Description Module


Ignite Creation Date: 2026-03-26 @ 3:16 PM
Ignite Modification Date: 2026-03-26 @ 3:16 PM
NCT ID: NCT07470632
Brief Summary: This randomized clinical trial aimed to compare the effectiveness of Mandala coloring and Twin Hearts Meditation in reducing exam anxiety among undergraduate nursing students. Participants were randomly assigned to either the Mandala coloring group or the Twin Hearts Meditation group. Both interventions were administered before a practical examination. Anxiety levels were measured before and after the intervention using the State-Trait Anxiety Inventory (STAI). The study evaluated which complementary and non-pharmacological intervention was more effective in reducing exam-related anxiety among nursing students.
Detailed Description: Study Purpose The purpose of this study was to compare the effectiveness of Mandala coloring and Twin Hearts Meditation as complementary and non-pharmacological interventions for reducing exam anxiety among undergraduate nursing students. Study Design This study was designed as a randomized clinical trial conducted among undergraduate nursing students. Participants were randomly assigned to two intervention groups: Mandala coloring and Twin Hearts Meditation. Sample Size Out of 110 eligible nursing students, 100 who met the inclusion criteria were recruited. Based on previous research and a mean comparison formula with a significance level of 0.05 and a statistical power of 80%, the required sample size was calculated as 48 participants per group. Considering possible dropout, 50 participants were included in each group. Data Collection Tools Data were collected using: * A demographic questionnaire (age, gender, marital status, academic information) * The State-Trait Anxiety Inventory (STAI), a validated 40-item self-report instrument measuring state and trait anxiety. Intervention Participants were randomly assigned to one of two groups: Twin Hearts Meditation Group: Participants received a guided Twin Hearts Meditation session lasting 30 minutes under the supervision of the researcher. Mandala Coloring Group: Participants engaged in mandala coloring for 30 minutes using printed mandala designs and colored pencils under the supervision of the researcher. Both interventions were conducted before a practical examination. Outcome Assessment Anxiety levels were measured before and after the intervention using the State-Trait Anxiety Inventory (STAI). Ethical Considerations The research received approval from the Cyprus International University Ethics Review Board (Approval No: EKK23-24/012/07). The study followed the ethical standards of the Council of Ethics and adhered to the principles of the Declaration of Helsinki (1964). Statistical Analysis Data were analyzed using SPSS software. Descriptive statistics, paired t-tests, independent t-tests, and chi-square tests were used. A P value \< 0.05 was considered statistically significant.
Study: NCT07470632
Study Brief:
Protocol Section: NCT07470632