Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 10:40 AM
Study NCT ID:
NCT05288634
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tampa Kinesiophobia Scale', 'timeFrame': 'the day before the surgery', 'description': ': It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'the day before the surgery', 'description': 'It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.'}], 'secondaryOutcomes': [{'measure': 'Tampa Kinesiophobia Scale', 'timeFrame': 'third day after surgery', 'description': 'It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'third day after surgery', 'description': 'It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'We aimed to assess the influence of progressive muscle relaxation exercise on kinesiophobia and pain during after lumbar disc surgery using the Visual Analog Scale (VAS) and the Tampa Kinesiophobia Scale in a prospective, randomized fashion.', 'detailedDescription': "Lumbar disc herniation (LDH) is a common disease that is common in the society and limits the activities of individuals in daily life. Pain, which is an undesirable but expected result of surgical interventions, which are used in the treatment of diseases and play an important role in increasing the health level of people, is one of the most common postoperative complaints. The pain is sometimes severe enough to impede movement and causes paravertebral muscle spasm. Pain can also cause kinesiophobia, which is a factor that limits the person's physical activities. This study was conducted to determine the effect of progressive muscle relaxation exercises on kinesiophobia, which can be seen in parallel with pain in the postoperative period, on the pain level of patients after LDH surgery and on the kinesiophobia experienced in parallel.\n\nThe following hypotheses (H) were tested in this study:\n\nH1. Progressive muscle relaxation exercise has an effect on reducing pain after LDH surgery.\n\nH2. Progressive muscle relaxation exercise has an effect on reducing kinesiophobia after LDH surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • The patients included in the study had lumbar microdiscectomy surgery,\n\n * Patients aged 18 and over\n * Patients should not have any problems that would prevent them from expressing their pain level correctly and from understanding the information given,\n * The patients do not have any psychological disorders,\n * The patients do not have any other acute disease that will cause pain.\n\nExclusion Criteria:\n\n* • Being diagnosed with a psychiatric disorder,\n\n * A complication (bleeding, hospital infection, etc.) developed in the patients before, during and after the operation within three days,\n * Not knowing Turkish.'}, 'identificationModule': {'nctId': 'NCT05288634', 'briefTitle': 'The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aksaray University'}, 'officialTitle': 'The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery', 'orgStudyIdInfo': {'id': '2020/01-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Routine maintenance and Progressive relaxation exercise practice', 'interventionNames': ['Other: Progressive relaxation exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine maintenance'}], 'interventions': [{'name': 'Progressive relaxation exercise', 'type': 'OTHER', 'description': 'Progressive relaxation exercise is a type of exercise that involves voluntary stretching and relaxation of major muscle groups in the human body, from the hands to the feet.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Aksaray', 'state': 'None Selected', 'country': 'Turkey (Türkiye)', 'facility': 'Aksaray University', 'geoPoint': {'lat': 38.37255, 'lon': 34.02537}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aksaray University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Funda Cetinkaya', 'investigatorAffiliation': 'Aksaray University'}}}}