Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 11:03 AM
Study NCT ID:
NCT07456527
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Mindfulness Based Physical Therapy on Burnout Syndrome Among University Students.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessor Blinded RCT'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study uses a parallel-group randomized controlled design. Participants are randomly assigned to either a Mindfulness-Based Physical Therapy (MBPT) intervention group or a control group receiving standard physical therapy. The intervention is delivered over six weeks, three sessions per week, and outcomes are assessed at baseline and post-intervention. The study is assessor-blinded to reduce measurement bias.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Burnout Score', 'timeFrame': 'Baseline and Week 6 (post-intervention)', 'description': 'The primary outcome is the change in student burnout, measured with the School Burnout Inventory (SBI), which evaluates three domains: exhaustion related to study demands, cynicism toward academic work, and sense of inadequacy as a student. Higher scores indicate greater burnout. The study will assess the mean subscale scores at baseline and Week 6. A decrease in scores indicates a reduction in burnout symptoms following the intervention.'}], 'secondaryOutcomes': [{'measure': 'Reduction in Musculoskeletal Pain', 'timeFrame': 'Baseline and Week 6 (post-intervention)', 'description': 'Musculoskeletal pain will be evaluated using the Nordic Musculoskeletal Questionnaire (NMQ), which assesses the presence and location of musculoskeletal pain or discomfort over the past 12 months. Pain levels will be recorded at baseline and Week 6. A reduction in reported symptoms will indicate improvement due to the intervention.'}, {'measure': 'Improvement in Quality of Life', 'timeFrame': 'Baseline and Week 6 (post-intervention)', 'description': 'Quality of life will be assessed using the World Health Organization Quality of Life Instrument (WHOQOL-BREF), which measures physical, psychological, social, and environmental domains. Higher scores indicate better quality of life. Scores will be collected at baseline and Week 6. An increase in domain scores will indicate improvement following the intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness Based Physical Therapy, MBPT, Mindfulness, Physical Therapy, Burnout, Musculoskeletal pain, Quality of life, University students, RCT'], 'conditions': ['Burnout Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether a mindfulness-based physical therapy intervention can reduce burnout syndrome and improve musculoskeletal pain and quality of life among undergraduate Allied Health Sciences students aged 18-30 years who are experiencing burnout symptoms, musculoskeletal pain, and reduced quality of life.\n\nThe main questions it aims to answer are:\n\n* Does a structured Mindfulness-Based Physical Therapy (MBPT) program reduce burnout symptoms compared to standard physical therapy alone?\n* Does MBPT improve musculoskeletal pain and quality of life compared to standard physical therapy alone?\n\nResearchers will compare a Mindfulness-Based Physical Therapy intervention group to a control group receiving a standardized physical therapy program to determine whether the addition of mindfulness techniques results in greater improvements in burnout, pain, and quality of life.\n\nParticipants will:\n\n* Be randomly assigned to either the intervention or control group.\n* Attend supervised 60-minute sessions three times per week for six weeks (total of 18 sessions).\n* Receive a standardized baseline physical therapy program consisting of full-body active range of motion and general mobility exercises within pain-free limits.\n* If assigned to the intervention group, receive structured mindfulness meditation, breathing exercises, posture correction, stretching, progressive muscle relaxation, and group reflection during each session.\n* Complete 10-15 minutes of daily home mindfulness practice (intervention group only).\n* Complete validated questionnaires at baseline and immediately after the 6-week intervention.', 'detailedDescription': 'Burnout and musculoskeletal pain are common issues affecting university students, often resulting from prolonged stress, poor posture, and high academic demands. Mindfulness-based interventions have been shown to reduce stress, enhance resilience, and improve mental well-being. Physical therapy interventions, including exercise and rehabilitative techniques, target musculoskeletal pain and functional limitations. Combining mindfulness with physical therapy may provide a holistic, non-invasive approach to improving both mental and physical health in students.\n\nThis study evaluates the impact of a structured Mindfulness-Based Physical Therapy (MBPT) program on burnout syndrome, musculoskeletal pain, and quality of life among undergraduate Allied Health Sciences students aged 18-30 years. Participants will engage in a six-week program supervised by trained professionals, incorporating mindfulness exercises, stretching, posture correction, progressive muscle relaxation, and home practice. The control group will receive standard physical therapy, allowing the study to assess the additional benefits of the mindfulness component.\n\nThe findings of this trial may provide evidence for a low-cost, integrative intervention that universities can implement to support student health and wellness. If effective, MBPT could serve as a model for combined mind-body programs, helping to reduce burnout, improve functional capacity, and enhance quality of life, potentially contributing to better academic performance and long-term health outcomes. This research addresses a gap in the literature on combined mindfulness and physical therapy interventions for university populations and may inform the development of future student wellness initiatives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* University Students aged 18-30 years enrolled in an undergraduate Allied Health Sciences program.\n* Reporting burnout symptoms as assessed by the School Burnout Inventory (SBI).\n* Having musculoskeletal pain in at least one body region during the past 7 days or past 12 months (Assessed by the Nordic Musculoskeletal Questionnaire).\n* Having decline in the quality of life in at least one domain (physical, psychological, social, or environmental) (Assessed by the WHOQOL-BREF questionnaire).\n\nExclusion Criteria:\n\n* Current diagnosis of any psychiatric disorder or taking any medicine.\n* Current participation in another mindfulness, yoga or meditation intervention.\n* Musculoskeletal injury requiring surgical or medical care.\n* Student who has had major life upheavals recently, such as a family member loss.'}, 'identificationModule': {'nctId': 'NCT07456527', 'briefTitle': 'Evaluating the Impact of Mindfulness Based Physical Therapy on Burnout Syndrome Among University Students.', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Evaluating the Impact of Mindfulness Based Physical Therapy on Burnout Syndrome Among University Students.', 'orgStudyIdInfo': {'id': 'UHS/USERC-26/SEC/98'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Physical Therapy (Control Group)', 'description': 'The control group will receive a standardized baseline physical therapy program consisting of supervised full-body active range of motion exercises and general mobility exercises (shoulder rolls, arm swings, and pelvic tilts) throughout the study duration. All exercises will be performed within pain-free limit', 'interventionNames': ['Behavioral: Standard Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness-Based Physical Therapy (MBPT)', 'description': 'The intervention group will undergo a standardized baseline physical therapy program followed by a structured Mindfulness-Based Physical Therapy (MBPT) program delivered over six consecutive weeks, three supervised 60-minute sessions per week, under the guidance of a registered physical therapist. Participants will also be instructed to perform daily home practice for 10-15 minutes.', 'interventionNames': ['Behavioral: Mindfulness Based Physical Therapy']}], 'interventions': [{'name': 'Standard Physical Therapy', 'type': 'BEHAVIORAL', 'description': 'A supervised physical therapy program consisting of full-body active range of motion and general mobility exercises, including shoulder rolls, arm swings, and pelvic tilts, performed within pain-free limits.', 'armGroupLabels': ['Standard Physical Therapy (Control Group)']}, {'name': 'Mindfulness Based Physical Therapy', 'type': 'BEHAVIORAL', 'description': 'Mindfulness Based Physical Therapy is a structured program combining supervised physical therapy exercises with mindfulness practices. The intervention includes guided mindfulness meditation (body scan and breath awareness), diaphragmatic and paced breathing exercises, posture correction and ergonomic education, gentle stretching of the neck, shoulders, and back, and progressive muscle relaxation. Sessions are delivered three times per week for six weeks under the supervision of a registered physiotherapist. Participants are also instructed to complete daily home practice incorporating mindfulness and stretching techniques.', 'armGroupLabels': ['Mindfulness-Based Physical Therapy (MBPT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'University of Health Sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Fansub Choudhary', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Health Sciences, Lahore, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Fansub Choudhary', 'investigatorFullName': 'Fansub Choudhary', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}