Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:30 AM
Study NCT ID:
NCT07415460
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-01-06', 'size': 558413, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-12T12:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perceived stress scale', 'timeFrame': '8 weeks', 'description': 'measured by 10 items. score ranges from 0 to 40. Score of 0-13 would be considered low stress, score of 14-26 would be considered moderate stress, score of 27-40 would be considered high perceived stress.'}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder Scale', 'timeFrame': '8 weeks', 'description': 'a seven item scale with score ranging from 0 to 21. score of 0-4: Minimal anxiety, score of 5-9: Mild anxiety, 10-14: Moderate anxiety, and 15-21: Severe anxiety.'}, {'measure': 'International physical activity scale - short form', 'timeFrame': '8 weeks', 'description': 'a seven-item scale with open ended questions for recalling physical activity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SKY Breath Meditation', 'perceived stress scale', 'GAD-7', 'IPAQ-short form'], 'conditions': ['Stress', 'Anxiety', 'Physical Activity']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Scott, K., Andrabi, M., Patiballa, S. K., McCoy, T., Shrestha, S., & Mumba, M. (2026). Breath of Resilience: Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students - A Pilot Feasibility Randomized Controlled Trial'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will evaluate the feasibility and potential benefits of Sudarshan Kriya Yoga (SKY) for university students. Over an eight-week period, 56 students will be randomly assigned to either a SKY breathwork group or a control group engaging in general yoga without breathwork. The SKY group will participate in a three-day in-person retreat, weekly virtual sessions, and independent home practice. The study will assess recruitment, retention, and adherence, as well as changes in physical activity, perceived stress, anxiety, resilience, social connectedness, and cognitive focus. All participants will complete validated wellness questionnaires at baseline and post-intervention. The goal is to determine whether SKY is a feasible, low-risk intervention that may enhance student well-being and inform future research.', 'detailedDescription': "The investigators are conducting a small pilot study to explore whether a specific type of breath-based meditation-Sudarshan Kriya Yoga (SKY)-can support the well-being of university students. Over the course of eight weeks, 56 undergraduate and graduate students will be randomly assigned to one of two groups: one group will take part in the SKY program, while the other will follow a general online yoga routine that does not include breathwork.\n\nParticipants in the SKY group will begin with a three-day in-person retreat, followed by weekly virtual sessions and independent home practice. The control group will engage in self-paced online yoga and receive occasional check-ins.\n\nThe primary focus of this study is feasibility: whether investigators can successfully recruit participants, maintain engagement, and support adherence to the intervention. The study will also examine whether SKY contributes to improvements in participants' physical and mental well-being. In addition to monitoring physical activity, the study will assess changes in perceived stress, anxiety, resilience, social connectedness, and cognitive focus-key areas that commonly affect student populations.\n\nAll participants will complete validated mental health and wellness questionnaires before and after the program. Data will be analyzed using statistical methods that include all enrolled participants, regardless of program completion. The SKY practices are considered low-risk and have been used in diverse populations; all data will be handled confidentially and securely.\n\nThis research is intended to lay the foundation for a larger study and provide early insight into how SKY breathwork practices may help students navigate academic demands with increased calm, clarity, and resilience."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must:\n\n 1. be currently enrolled as undergraduate or graduate students at the university in Alabama;\n 2. be at least 18 years old;\n 3. speak and read English;\n 4. be available to attend a 3-day in-person retreat and twice-weekly online sessions for SKY breath program over 8 weeks;\n 5. be able to provide informed consent.\n\nExclusion Criteria:\n\n* Participants will be excluded if they:\n\n 1. have a serious psychiatric condition (e.g., schizophrenia, psychotic disorders) that could be exacerbated by group-based interventions;\n 2. are in acute psychiatric crisis; such as, active suicidal ideation\n 3. have acute medical conditions that contraindicate light physical activity or breathwork;\n 4. are unable to obtain physician clearance for participation due to chronic conditions (e.g., uncontrolled asthma, severe cardiovascular disease, active psychiatric illness requiring intensive treatment).'}, 'identificationModule': {'nctId': 'NCT07415460', 'acronym': 'SKY Breath', 'briefTitle': 'Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama, Tuscaloosa'}, 'officialTitle': 'Breath of Resilience: Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students - A Pilot Feasibility Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '25-11-9227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group will receive online Yoga Videos to practice at least three times a week', 'description': 'Yoga videos to practice three times per week will be distributed to control group', 'interventionNames': ['Other: Yoga Videos']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'SKY breath meditation retreat for 3-days, once weekly online meditation session, and home practice.', 'interventionNames': ['Other: SKY Breath Meditation']}], 'interventions': [{'name': 'SKY Breath Meditation', 'type': 'OTHER', 'description': 'Three day in person retreat, weekly virtual sessions, home practice', 'armGroupLabels': ['Intervention group']}, {'name': 'Yoga Videos', 'type': 'OTHER', 'description': 'Pre-recorded yoga videos will be sent to the participants to perform yoga three times per week', 'armGroupLabels': ['control group will receive online Yoga Videos to practice at least three times a week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35401', 'city': 'Tuscaloosa', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Facilities and Grounds Main University of Alabama Contant Number', 'role': 'CONTACT', 'email': 'property@ua.edu', 'phone': '205-348-6010'}], 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}], 'centralContacts': [{'name': 'Sree K Patiballa, PhD', 'role': 'CONTACT', 'email': 'spatiballa@ua.edu', 'phone': '205-348-6163'}, {'name': 'Kunwal M. Scott, DNP', 'role': 'CONTACT', 'email': 'kmscott10@ua.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Apart from research team, no one will have access to the raw data. The information regarding the results shared will be after the data is de-identified.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama, Tuscaloosa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kay Molwani Scott', 'investigatorAffiliation': 'University of Alabama, Tuscaloosa'}}}}