Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-01 @ 9:42 PM
Study NCT ID:
NCT06457932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up', 'description': 'Measured using the Percieved Stress Scale (PSS).'}, {'measure': 'Anxiety State', 'timeFrame': 'T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up', 'description': 'Measured using the State-Trait Anxiety Inventory (STAI).'}], 'secondaryOutcomes': [{'measure': 'Heart Rate Variability (HRV)', 'timeFrame': 'T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up', 'description': 'Measured using the Polar H10 band and Elite HRV app.'}, {'measure': 'Academic Performance', 'timeFrame': 'T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up', 'description': 'Semester grade averages compared between groups.'}, {'measure': 'Adherence', 'timeFrame': 'Daily during the 8 week intervention', 'description': 'Tracked using an online calendar.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Anxiety State']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and a control group, in reducing stress and anxiety levels among university undergraduate students.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Second- and third-year students of the Physiotherapy Degree at various universities in the province of Seville.\n2. Enrolled in all courses for the academic year.\n3. Enrolled in the courses for the first or second time.\n\nExclusion Criteria:\n\n1. Having a job in addition to academic responsibilities.\n2. Having a dependent family member under their care.\n3. Diagnosed with any mental health issues.\n4. Diagnosed with severe metabolic, cardiovascular, or respiratory conditions, or cancer.\n5. Simultaneously pursuing another degree or a dual degree program.'}, 'identificationModule': {'nctId': 'NCT06457932', 'briefTitle': 'Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students.', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress and Anxiety Levels in University Undergraduate Students.', 'orgStudyIdInfo': {'id': '77859612N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biofeedback training', 'description': 'An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.', 'interventionNames': ['Behavioral: Heart rate variability biofeedback training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meditation', 'description': 'An 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation.', 'interventionNames': ['Behavioral: Guided meditation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Passive, waitlist control group.'}], 'interventions': [{'name': 'Heart rate variability biofeedback training', 'type': 'BEHAVIORAL', 'description': 'An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.', 'armGroupLabels': ['Biofeedback training']}, {'name': 'Guided meditation', 'type': 'BEHAVIORAL', 'description': 'An 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation.', 'armGroupLabels': ['Meditation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hermann Fricke-Comellas, PhD Student', 'role': 'CONTACT', 'email': 'hfricke@us.es', 'phone': '672279589', 'phoneExt': '+34'}], 'overallOfficials': [{'name': 'Hermann Fricke-Comellas, PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Seville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Hermann Fricke Comellas', 'investigatorAffiliation': 'University of Seville'}}}}