Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
Study NCT ID:
NCT06824857
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2024-10-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2025-02-08', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time To Defecate', 'timeFrame': 'From the 6th hour after surgery until the end of the 3rd day after surgery', 'description': 'Time of first defecation'}, {'measure': 'Bowel Sounds', 'timeFrame': 'From the 6th hour after surgery until the end of the 3rd day after surgery', 'description': 'Frequency of bowel sounds heard per minute'}, {'measure': 'Abdominal Distension', 'timeFrame': 'From the 6th hour after surgery until the end of the 3rd day after surgery', 'description': 'To be assessed by measuring the abdominal circumference with a tape measure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subarachnoid hemorrhage', 'Abdominal massage', 'bowel movements', 'nursing'], 'conditions': ['Subarachnoid Haemorrhage (SAH)']}, 'descriptionModule': {'briefSummary': 'The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.', 'detailedDescription': 'The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit. The sample of the study will consist of a total of 64 patients, 32 in the experimental group and 32 in the control group, hospitalized in the tertiary neurosurgery intensive care unit. Data collection tools are the "Descriptive Characteristics Form" and the "Patient Follow-up Form".The statistician will determine whether the patients who meet the sampling criteria will be assigned to the experimental or control group through randomization. The stratified randomization method will be used in the study. In this context, patients who meet the inclusion criteria from the start date of the study in the Neurosurgery Intensive Care Unit will be randomized by assigning them to the control group and abdominal massage groups, respectively. Patients will be assigned to the control and abdominal massage groups in this order until the sample size is reached. The CONSORT diagram will be used in the randomization of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • 18 years of age or older\n\n * Underwent neurovascular surgery\n * Received general anesthesia\n * Have no wounds, surgical intervention, or radiotherapy in the abdominal region\n * Have no bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, abdominal herniation, or bowel cancer\n * Began oral feeding at the 6th hour post-surgery\n * Stayed in the intensive care unit for 3 or more days\n * Have a Glasgow Coma Scale (GCS) score of 9 or above\n * Have no signs of acute abdomen\n * Have no intra-abdominal infection\n * No mechanical ventilation\n * Mobilezed in the preoperative period\n * Unable to mobilize after surgery\n * Evaluated by the intensive care physician with no contraindications for abdominal massage\n * Have a first-degree relative who has given consent\n\nExclusion Criteria:\n\n* Patients with the following conditions will be excluded from the sample:\n\n * Those with chronic constipation, fecal incontinence, or diarrhea\n * Those fed with a fiber-enriched nutritional solution (e.g., Nutrison Protein Plus Multifibre®, Fresubin Original Fibre®, Isosource Fiber®, Jevity Plus®)\n * Those fed via nasogastric enteral tube\n * Those receiving parenteral nutrition\n * Patients with a BMI \\> 40 (morbid obesity)'}, 'identificationModule': {'nctId': 'NCT06824857', 'acronym': 'Massage', 'briefTitle': 'Effect of Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effect of Postoperative Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '2024 - 306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abdominal Massage Application Group', 'description': 'After explaining the purpose of the study to the relatives of patients in the abdominal massage group, the "Introductory Characteristics Form" will be filled out. Abdominal massage will be performed according to the Checklist at the 6th hour after surgery and at the same times in the morning and evening for the first 3 days post-surgery. Before and 15 minutes after the abdominal massage application, bowel sounds will be auscultated, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed and recorded in the patient follow-up form.', 'interventionNames': ['Other: Abdominal Massage Application']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'After explaining the purpose of the study to the relatives of patients in the control group, the "Introductory Characteristics Form" will be filled out. At the same times as the experimental group, bowel sounds will be auscultated in the control group without any intervention, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed'}], 'interventions': [{'name': 'Abdominal Massage Application', 'type': 'OTHER', 'description': 'As part of the abdominal massage application, patient follow-up forms and checklists were prepared. Before starting the study, the abdominal massage practitioner participated in a certification program on this topic and received a competency certificate. Patients will be followed up for the first 3 days postoperatively using the prepared patient follow-up forms. Abdominal massage will be applied to each patient for 15 minutes according to a certain standard as stated in the literature', 'armGroupLabels': ['Abdominal Massage Application Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Nursing, Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, PhD, Assistant Professor', 'investigatorFullName': 'Zühal Erdoğan', 'investigatorAffiliation': 'Gazi University'}}}}