Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:26 AM
Study NCT ID:
NCT07470632
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Twin Hearts Meditation and Mandala Coloring on Exam Anxiety in Nursing Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'To reduce bias, the investigator responsible for data collection and the statistician analyzing the data were blinded to group assignments. The intervention groups were coded as anonymous variables during data analysis.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to two intervention groups: Mandala Coloring and Twin Hearts Meditation. Both interventions were administered before the practical examination. Anxiety levels were measured before and after the intervention using the State-Trait Anxiety Inventory (STAI) to evaluate the effectiveness of each intervention in reducing exam anxiety among nursing students.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exam Anxiety Levels', 'timeFrame': 'Anxiety levels are assessed at two time points: before the intervention (two hours prior to the OSCE) and immediately after the intervention prior to the examination.', 'description': 'The primary outcome measure evaluates changes in exam-related anxiety levels among nursing students following the Mandala coloring and Twin Hearts Meditation interventions. Anxiety is measured using the State-Trait Anxiety Inventory (STAI), a validated psychological instrument that assesses both state and trait anxiety. The STAI consists of two subscales with 20 items each, scored on a 4-point Likert scale. Higher scores indicate greater levels of anxiety.\n\nBoth groups completed the State-Trait Anxiety Inventory (STAI) two hours before the Objective Structured Clinical Examination (OSCE), immediately prior to the intervention, and again immediately after the intervention.'}, {'measure': 'Test Anxiety Levels', 'timeFrame': 'Anxiety levels are assessed at two time points: before the intervention (two hours prior to the OSCE) and immediately after the intervention prior to the examination.', 'description': 'The primary outcome measure evaluates changes in exam-related anxiety levels among nursing students following the Mandala coloring and Twin Hearts Meditation interventions. Anxiety is measured using the State-Trait Anxiety Inventory (STAI), a validated psychological instrument that assesses both state and trait anxiety. The STAI consists of two subscales with 20 items each, scored on a 4-point Likert scale. Higher scores indicate greater levels of anxiety.\n\nBoth groups completed the State-Trait Anxiety Inventory (STAI) two hours before the Objective Structured Clinical Examination (OSCE), immediately prior to the intervention, and again immediately after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complementary Therapies', 'Meditation', 'Art Therapy', 'Students, Nursing'], 'conditions': ['Exam Anxiety']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Study Purpose\n\nThe 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.\n\nStudy Design\n\nThis 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.\n\nSample Size\n\nOut 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.\n\nData Collection Tools\n\nData were collected using:\n\n* A demographic questionnaire (age, gender, marital status, academic information)\n* The State-Trait Anxiety Inventory (STAI), a validated 40-item self-report instrument measuring state and trait anxiety.\n\nIntervention\n\nParticipants were randomly assigned to one of two groups:\n\nTwin Hearts Meditation Group:\n\nParticipants received a guided Twin Hearts Meditation session lasting 30 minutes under the supervision of the researcher.\n\nMandala Coloring Group:\n\nParticipants engaged in mandala coloring for 30 minutes using printed mandala designs and colored pencils under the supervision of the researcher.\n\nBoth interventions were conducted before a practical examination.\n\nOutcome Assessment\n\nAnxiety levels were measured before and after the intervention using the State-Trait Anxiety Inventory (STAI).\n\nEthical Considerations\n\nThe 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).\n\nStatistical Analysis\n\nData 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All undergraduate nursing students in their first semester, male or female, enrolled in the English-language nursing program.\n2. Students not using other stress-reduction methods (e.g., progressive muscle relaxation, pharmacological therapy).\n3. Students who voluntarily agreed to participate and provided informed consent.\n\nExclusion Criteria:\n\n1. Unwilling to continue cooperation in the project.\n2. Using any psycho medicines (anti-depressants ...), mental health.\n3. Mourning, especially the death of loved ones or relatives in the 1st phase.'}, 'identificationModule': {'nctId': 'NCT07470632', 'acronym': 'Mandala', 'briefTitle': 'Effect of Twin Hearts Meditation and Mandala Coloring on Exam Anxiety in Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'Near East University, Turkey'}, 'officialTitle': 'Comparison of Mandala Coloring and Twin Hearts Meditation on Practical Exam Anxiety: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PVF2026Mandalamed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Twin Hearts Meditation', 'description': 'Behavioral: Twin Heart Meditation Participants in this group receive the Twin Heart Meditation intervention, a guided meditative technique based on the principles of loving-kindness and spiritual energy. The intervention is designed to reduce exam-related anxiety by promoting inner peace and emotional regulation.', 'interventionNames': ['Behavioral: Twin Heart Meditation', 'Behavioral: Mandala Coloring']}, {'type': 'EXPERIMENTAL', 'label': 'Mandala Coloring', 'description': 'Participants in this group engage in mandala coloring, an art-based mindfulness activity designed to reduce exam anxiety and promote relaxation.', 'interventionNames': ['Behavioral: Twin Heart Meditation', 'Behavioral: Mandala Coloring']}], 'interventions': [{'name': 'Twin Heart Meditation', 'type': 'BEHAVIORAL', 'description': 'Participants in this group receive Twin Hearts Meditation, a guided meditation technique based on the principles of loving-kindness and spiritual energy. The intervention aims to reduce exam-related anxiety by promoting emotional balance and relaxation.\n\nIntervention:\n\nBehavioral: Twin Hearts Meditation\n\nParticipants practice guided meditation sessions lasting 30 minutes under the supervision of the researcher. The meditation protocol includes:\n\nPhysical warm-up exercises\n\nActivation of the heart chakra\n\nActivation of the crown chakra\n\nBlessing the Earth with loving-kindness\n\nSilent meditation using the phrase "Amen"\n\nExpression of gratitude\n\nClosing exercises\n\nSessions are conducted in a quiet room using audio guidance.', 'armGroupLabels': ['Mandala Coloring', 'Twin Hearts Meditation']}, {'name': 'Mandala Coloring', 'type': 'BEHAVIORAL', 'description': 'Participants were provided with a printed mandala outline on A4 paper and six colored pencils (red, orange, yellow, green, blue, purple). They engaged in free, unstructured mandala coloring for 30 minutes', 'armGroupLabels': ['Mandala Coloring', 'Twin Hearts Meditation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nicosia', 'state': 'North Cyprus', 'country': 'Cyprus', 'facility': 'KKTC (Turkish Republic Of Northern Cyprus)', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}], 'overallOfficials': [{'name': 'Pouran Varvani Farahani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Near East University, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University,', 'investigatorFullName': 'Pouran Varvani Farahani', 'investigatorAffiliation': 'Cyprus International University'}}}}