Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 12:12 PM
Study NCT ID:
NCT06534294
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol Levels', 'timeFrame': 'At subject enrollment "single session"', 'description': '2 tubes of blood samples (5 mL) will take from the patients in all groups on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level'}, {'measure': 'Distress Thermometer', 'timeFrame': 'At subject enrollment "single session"', 'description': 'It is a visual analog scale consisting of only 1 question that patients can apply on their own. On the scale, there is a thermometer with numbers from 0 to 10. A score of 0 indicates that the individual has no distress, and a score of 10 indicates distress at the highest limit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Transluminal Coronary Angioplasty']}, 'descriptionModule': {'briefSummary': 'Effect of non-pharmacological anti-anxiety exercises on Perceived Stress and cortisol level before elective percutaneous transluminal coronary angioplasty', 'detailedDescription': 'patients will be selected from national heart institute their age from 30 -50 years old. Patients will be assigned randomly into 4 groups 15 in each group, reflexology group, deep breathing group, combined group (reflexology and deep breathing) and control group. Before procedure two tools will used to collect data (demographic characteristics format the beginning once and Distress Thermometer scale before and 30 minutes after application in all groups ) in addition blood samples (5 mL) will take from all the patients on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level in all groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fully conscious patients, aged from 30 to 50 years.\n* will do percutaneous transluminal coronary angioplasty for the first time without any problem of communication.\n* accepting to give Blood samples available between 08:30 and 10:00 in the morning (to avoid differences in cortisol levels), and agreeing to participate in the study\n\nExclusion Criteria:\n\n* having myocardial infarction symptoms,\n* unconscious, having a surgery in the last 6 weeks,\n* previously diagnosed with a psychiatric disorder or still having a psychiatric disease, using anxiety medication (psychotropic), corticosteroid, using estrogen or amphetamine derivative drugs,\n* infection of the lower extremities, having varicose veins, having peripheral neuropathy and deep vein thrombosis or risk of development, high fever,'}, 'identificationModule': {'nctId': 'NCT06534294', 'briefTitle': 'Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty', 'orgStudyIdInfo': {'id': 'IHC00070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP1', 'description': 'Reflexology procedure will applied to patients in calm, quiet patient room with adequate light and in the supine position. For the relaxation of patients 10 minutes of relaxation techniques and stimulation of the reflexology points before reflexology, Reflex therapy was done for each patient for 30 minutes, first for the right foot and then for the left foot (15 minutes each)', 'interventionNames': ['Other: reflexology']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP2', 'description': 'patients carried out breathing exercises AS 3 stages(13), stage one Beginning stage for 5 minutes will ask the patients to Sit , Flatten the shoulders, open the legs, and place your arms at your sides naturally , Close eyes and focus on present feelings , stage two deep breathing stage for 10 minutes Exercises were deep breathing exercises; deep inspiration for 5 seconds and slow prolonged expiration for next 5 seconds, at a rate of 6 breaths/min, rest for one minute after each cycle , then apply the exercises again , end stage ; Close eyes and focus your present feelings, Then Relax the whole body for 5 minutes.', 'interventionNames': ['Other: breathing exercise']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP3', 'description': 'procedure that will done in reflexology and deep breathing will applied', 'interventionNames': ['Other: reflexology', 'Other: breathing exercise']}, {'type': 'OTHER', 'label': 'GROUP4', 'description': 'In this group: will received only standard care', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'reflexology', 'type': 'OTHER', 'description': 'Reflex therapy was done for each patient for 30 minutes, first for the right foot and then for the left foot (15 minutes each) and breathing exercises in 3 stages', 'armGroupLabels': ['GROUP1', 'GROUP3']}, {'name': 'breathing exercise', 'type': 'OTHER', 'description': 'breathing exercise done as 3 stages,stage one for 5 minutes, stage two for 10 minutes end stage ; Close eyes and focus your present feelings, Then Relax the whole body for 5 minutes.', 'armGroupLabels': ['GROUP2', 'GROUP3']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'standard medical care no other treatment', 'armGroupLabels': ['GROUP4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32897', 'city': 'Sadat', 'state': 'Menofia', 'country': 'Egypt', 'facility': 'Al Ryada University for Science and Technology', 'geoPoint': {'lat': 31.22371, 'lon': 34.20837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Amira Mohamed Afify', 'investigatorAffiliation': 'October 6 University'}}}}