Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-27 @ 8:23 AM
Study NCT ID:
NCT06591832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'Min 0 Max 10 (As the score increases, the pain increases.)', 'description': 'Visual Analog Scale'}, {'measure': 'Tampa kinesiophobia scale', 'timeFrame': 'min 17 max 68 (As the score increases, the fear of movement increases.)', 'description': 'assesses fear of movement'}], 'secondaryOutcomes': [{'measure': 'After application Visual Analog Scale', 'timeFrame': 'Min 0 Max 10 (As the score increases, the pain increases.)', 'description': 'Visual Analog Scale'}, {'measure': 'After application Tampa kinesiophobia scale', 'timeFrame': 'min 17 max 68 (As the score increases, the fear of movement increases.)', 'description': 'assesses fear of movement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'kinesiophobia', 'virtual reality glasses'], 'conditions': ['Randomized Controlled Trial']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of virtual reality-based relaxation exercise on pain and kinesiophobia in patients after total knee arthroplasty.', 'detailedDescription': "Virtual reality application, which is a non-pharmacological application; It is a three-dimensional simulation model that gives individuals the feeling of reality and allows mutual communication with a dynamic environment created by computers, and studies determining the effects of the application are increasing day by day. Virtual reality-based rehabilitation is a promising approach to achieve recovery in many cases, optimize functional outcomes, and increase the clinical and social benefits of surgery . As a result, pain and fear of movement may negatively affect early functional results in patients undergoing total knee arthroplasty. Explaining how to change patients' fears, encouraging them to adopt positive attitudes and increasing their physical strength has an important place in determining the effectiveness of virtual reality application."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The research included people between the ages of 40-75,\n* Volunteering to participate in the research,\n* Being able to understand and speak Turkish,\n* Being able to understand the verbal, written and video explanations given,\n* Having no problems communicating cognitively, affectively and verbally,\n* Not having any obstacle to using virtual reality glasses,\n* Patients who underwent unilateral TKA surgery,\n* Using the SPH device at the same degree for three postoperative days after the FFP operation.\n* Having the surgeon's permission\n\nExclusion Criteria:\n\n* Patients who will undergo revision TDP surgery,\n* Those who have a neurological disease that causes functional disability,\n* Those with a diagnosed psychiatric disorder,\n* Refusing to take the SPH device after the operation or taking it to a different degree,\n* Those who have a condition that prevents them from wearing virtual glasses for any reason,\n* These are patients after the FFP operation and outside the third postoperative day."}, 'identificationModule': {'nctId': 'NCT06591832', 'briefTitle': 'Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Aksaray University'}, 'officialTitle': 'Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement: Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2023/23-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Gorup', 'description': 'Routine nursing practice will be performed and Virtual reality based progressive relaxation exercise will be applied', 'interventionNames': ['Other: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Routine nursing practice will be performed'}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Virtual reality based progressive relaxation exercise', 'armGroupLabels': ['Experimental Gorup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Aksaray', 'country': 'Turkey (Türkiye)', 'facility': 'Aksaray University', 'geoPoint': {'lat': 38.37255, 'lon': 34.02537}}, {'city': 'Aksaray', 'country': 'Turkey (Türkiye)', 'facility': 'Aksaray Universitesi', 'geoPoint': {'lat': 38.37255, 'lon': 34.02537}}], 'overallOfficials': [{'name': 'Zeynep Koçak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aksaray University'}, {'name': 'Funda Çetinkaya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aksaray University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aksaray University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zeynep Kocak', 'investigatorAffiliation': 'Aksaray University'}}}}