Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-01 @ 12:26 AM
Study NCT ID:
NCT06871332
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain level', 'timeFrame': 'One minute after femoral sheath removal', 'description': "Patients' pain is evaluated with the Visual Analog Scale (VAS) .The VAS is a 10 cm long ruler drawn horizontally or vertically. Patients were told that 0 on the scale means no pain and 10 means unbearable pain at the highest level. The patient was asked to mark the point on this scale indicating the level of pain they felt."}, {'measure': 'Anxiety level', 'timeFrame': 'One minute after femoral sheath removal', 'description': "Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. patients were told that 0 on the scale means no anxiety and 10 means unbearable anxiety at the highest level. The patient was asked to mark the point on this scale indicating the level of anxiety they felt."}, {'measure': 'Patient satisfaction', 'timeFrame': 'One minute after sheath removal', 'description': "Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. It was explained to the patient that the number 0 indicated no satisfaction with the application and the number 10 indicated the highest level of satisfaction and the patient was asked to mark on the ruler."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Femoral Sheath', 'Pain', 'Progressive Relaxation Exercise', 'Satisfaction'], 'conditions': ['Effect of Progressive Relaxation Exercise']}, 'descriptionModule': {'briefSummary': 'This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.', 'detailedDescription': 'This study aimed to determine the effect of progressive relaxation exercise (PRE) applied to patients undergoing percutaneous coronary intervention (PCI) on pain, anxiety and patient satisfaction related to femoral sheath removal. This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed PRE for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to speak and understand Turkish,\n* over 18 years of age,\n* intervened in the femoral region,\n* with only one catheter in the femoral region,\n* without vision and hearing problems,\n* undergoing angiography procedure for the first time,\n* with normal vital signs,\n* who have not been administered analgesics for any reason prior to sheath removal after the procedure,\n* patients who volunteered to participate in the study were included in the study.\n\nExclusion Criteria:\n\n* patients with chronic pain using transdermal patches,\n* patients with impaired time and place orientation,\n* patients with psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT06871332', 'briefTitle': 'Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effect of Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction Related to Femoral Sheath Removal: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2022/543'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progressive relaxation exercises group', 'description': 'Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal.', 'interventionNames': ['Other: Progressive relaxation exercise group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The patients in the control group received the standard practice of the clinic.'}], 'interventions': [{'name': 'Progressive relaxation exercise group', 'type': 'OTHER', 'description': 'Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal.', 'armGroupLabels': ['Progressive relaxation exercises group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Talas', 'state': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.6908, 'lon': 35.5538}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof.Dr.', 'investigatorFullName': 'Sevda Korkut', 'investigatorAffiliation': 'TC Erciyes University'}}}}