Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07070505
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hand Massage for Physical Restraint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Patients in this group will be subjected to routine monitoring as per the hospital procedure every 30 minutes. In addition, one of the patient's wrists that is under restraint will be opened for 5 minutes every 30 minutes and a hand massage will be applied. The open wrist will be restricted again after the 5 minutes are completed. This application will be repeated every 30 minutes until the total restriction period requested by the physician is completed. During the monitoring performed every 30 minutes, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature and pain will be evaluated and recorded in the Patient Information and Restriction Monitoring Form."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "During the 30. 60th. 90. 120. minutes follow-up, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature and pain will be evaluated.", 'timeFrame': 'for 2 hours', 'description': 'Peripheral capillary refill time\n\n( 0-2 sec : + ) ( \\>2 sec : ++ ) Skin integrity + yes\n\n\\- no\n\nIf yes, specify:\n\n* abrasion\n* irritation\n* laceration Specify skin color\n* Pale/white\n* red\n* bruised\n* pink Skin temperature\n\nCompared to unrestricted area\n\n* warmer\n* colder\n* no difference Pain (0-10 points) Ask the patient about the restricted area\n\n 0: I have no pain\n\n 10: Unbearable pain 30th min 60th min 90th min 120th min'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Restraints', 'Hand Massage']}, 'descriptionModule': {'briefSummary': "In this study, nurses will apply hand massage to patients who are physically restrained. It will be examined whether massage has a positive effect on patients' skin color, blood circulation, skin temperature and pain. Physical restraint will be applied to patients only in the presence of medical indications and with the decision of a physician.\n\nResearch question: Does hand massage applied to patients in physical restraint have an effect on preventing complications related to restraint?", 'detailedDescription': "There are 2 groups in the study: experimental and control. Patients in the control group will be subjected to the hospital's routine physical restraint practices and will not receive hand massage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both physical and chemical restraint must be applied, a written request for restraint must be given by the physician, both upper extremities must be restrained, and verbal permission must be obtained from the relatives.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07070505', 'acronym': 'Complications', 'briefTitle': 'Hand Massage for Physical Restraint', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Effect of Hand Massage on Physical Restraint Complications', 'orgStudyIdInfo': {'id': 'Adana City Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Patients in this group will be subjected to routine monitoring, which is included in the hospital procedure, every 30 minutes. Routine monitoring includes ensuring physical well-being, taking pulse, feeding, giving water, and meeting toilet needs. Records are kept by the nurse regarding these practices. During monitoring every 30 minutes, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature, and pain will be evaluated and recorded on the Patient Information and Restriction Monitoring Form."}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': "* Before applying hand massage, the individual/patient's hand or arm will be evaluated for thrombus, phlebitis, ecchymosis, hematoma, deterioration in skin integrity and change in skin color in order to determine whether there is a risk.\n* Hand massage application is a massage performed with western technique that includes five basic classical massage manipulations including efflorescence, petrissage, friction, tapotment and vibration.\n* Massage should be performed in a way that creates light pressure on the individual, then the applied pressure should be gradually increased.", 'interventionNames': ['Other: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': "* Before applying hand massage, the individual/patient's hand or arm will be evaluated for thrombus, phlebitis, ecchymosis, hematoma, deterioration in skin integrity and change in skin color in order to determine whether there is a risk.\n* Hand massage application is a massage performed with western technique that includes five basic classical massage manipulations including efflorescence, petrissage, friction, tapotment and vibration.\n* Massage should be performed in a way that creates light pressure on the individual, then the applied pressure should be gradually increased.", 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali Taşdemir', 'role': 'CONTACT', 'email': 'drmustafakurt61@gmail.com', 'phone': '05065943061'}], 'facility': 'Dr. Ekrem Tok Mental Health Hospital', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'centralContacts': [{'name': 'Ece Kurt', 'role': 'CONTACT', 'email': 'ece_ece3543@hotmail.com', 'phone': '90 0541 272 13 06'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer PhD', 'investigatorFullName': 'ECE KURT', 'investigatorAffiliation': 'Cukurova University'}}}}