Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 8:59 PM
Study NCT ID:
NCT06215066
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2023-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality and Progressive Muscle Relaxation on Anxiety and Attention Among Cardiac Care Unit Patients
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'], 'maskingDescription': 'Blinding was limited to the statistician (outcome assessor). Participants, care providers, and investigators were not blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total sample of 158 patients was required. A computer randomizer (www.randomizer.org\n\n) was used to assign numbers to patients who were included. A 1:1 randomized allocation was applied to assign patients to each group. As an active comparator, Group A received the virtual reality (VR) intervention (83 patients), whereas Group B received the modified progressive muscle relaxation (MPMR) intervention (75 patients). Blinding in this study was limited to the statistician.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of attention / distraction levels between both groups at the end of the intervention.', 'timeFrame': 'Attention / distraction levels were assessed individually for each patient during the night shift on the third day after completing all nine intervention sessions.', 'description': 'Compares attention / distraction levels using the Attention / Distraction Scale for both groups.'}], 'primaryOutcomes': [{'measure': 'Comparison of changes in physiological parameters between baseline and post-intervention scores for both groups.', 'timeFrame': 'Baseline physiological parameter assessments were conducted individually for each patient on the first day of the intervention. Post-intervention assessments were conducted during the same three shifts across the three-day period.', 'description': 'Compares the degree of change between baseline physiological parameters (heart rate and rhythm, respiratory rate and rhythm, oxygen saturation, blood pressure, and pain level) and post-intervention scores for both groups.'}], 'secondaryOutcomes': [{'measure': 'Comparison of changes in anxiety levels between baseline and post-intervention scores for both groups.', 'timeFrame': 'Baseline anxiety level assessments were conducted individually for each patient on the first day of the intervention. Post-intervention assessments were conducted during the same three shifts across the three-day period.', 'description': 'Compares the degree of change between baseline anxiety level (Hamilton Anxiety Rating Scale, HAM-A) and post-intervention scores for both groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety, Attention, Distraction Techniques, MPMR, VR.'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial with two parallel groups was conducted, to determine the effect of virtual reality (VR) and modified progressive muscle relaxation (MPMR) distraction techniques on anxiety, attention and getting distracted from the external environment among cardiac care unit patients.\n\nThe study is based on the following hypotheses:\n\nH1: Patients who receive VR intervention have lower Hamilton Anxiety Rating (HAM-A) scores than those who receive MPMR intervention.\n\nH2: Patients who receive VR intervention exhibit improvement in their physiological parameters than those who receive MPMR intervention.\n\nH3: Patients who receive VR intervention have higher Attention/Distraction scores than those who receive MPMR intervention.', 'detailedDescription': 'This randomized controlled trial with two parallel groups was conducted in the cardiac care unit of Smouha Hospital, affiliated with Alexandria University, Egypt.\n\nA total of 158 patients were recruited using a simple random sampling method and assigned to one of two groups to determine the effects of virtual reality (VR) and modified progressive muscle relaxation (MPMR) distraction techniques on anxiety, attention, and distraction from the external environment among cardiac care unit patients.\n\nFour assessment tools were used:\n\n1. Sociodemographic and Clinical Assessment.\n2. Physiological Parameter Assessment.\n3. Hamilton Anxiety Rating Scale (HAM-A).\n4. Attention/Distraction Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to CCU for at least 3 days after stability.\n* Patients who are conscious and stable condition and all of whom exhibited varying levels of anxiety.\n\nExclusion Criteria:\n\n\\- Patients with a history of neurological impairments such as motor, visual, and auditory disabilities and psychological disorders.'}, 'identificationModule': {'nctId': 'NCT06215066', 'briefTitle': 'Effect of Virtual Reality and Progressive Muscle Relaxation on Anxiety and Attention Among Cardiac Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Virtual Reality and Modified Progressive Muscle Relaxation Distraction Techniques on Anxiety and Attention Among Cardiac Care Unit Patients; RCT.', 'orgStudyIdInfo': {'id': 'Distraction Techniques'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality Group (VR)', 'description': "The intervention was administered three times per day, 10 minutes each session, for three consecutive days.\n\nThe VR goggles and headset phone were placed on the patient's head, straps secured, and lens spacing adjusted for a clear visual field. Patients were instructed to use head movements to control the cursor and interact with the virtual content. The 3D video clips with natural sceneries and background music were played to create a relaxing experience.", 'interventionNames': ['Device: Virtual reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified Progressive Muscle Relaxation Group (MPMR)', 'description': 'The intervention was administered three times per day, 10 minutes each session, for three consecutive days.\n\nThe exercises applied to specific body parts while patients closed their eyes and practiced deep breathing, accompanied by background music.', 'interventionNames': ['Other: Modified Progressive Muscle Relaxation']}], 'interventions': [{'name': 'Virtual reality', 'type': 'DEVICE', 'otherNames': ['VR'], 'description': "The VR goggles and headset phone were placed on the patient's head, straps secured, and lens spacing adjusted for a clear visual field. Patients were instructed to use head movements to control the cursor and interact with the virtual content. The 3D video clips with natural sceneries and background music were played to create a relaxing experience.", 'armGroupLabels': ['Virtual Reality Group (VR)']}, {'name': 'Modified Progressive Muscle Relaxation', 'type': 'OTHER', 'otherNames': ['MPMR'], 'description': 'The exercises applied to specific body parts while patients closed their eyes and practiced deep breathing, accompanied by background music.', 'armGroupLabels': ['Modified Progressive Muscle Relaxation Group (MPMR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Cardiac care unit of Smouha Hospital, which is affiliated to Alexandria University, Egypt.', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Sajeda A Shdaifat, PhD-Cand', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Azza H El-Soussi, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Mohamed I Sanhoury, Asst. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Eman A Ali, Asst. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Middle East University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}