Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT05334160
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2022-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Abdominal Breathing Exercises
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2022-04-10', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'During postoperative up to 24 hours'}, {'measure': 'NRS', 'timeFrame': 'During postoperative up to 24 hour'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Breathing']}, 'descriptionModule': {'briefSummary': 'Postoperative evaluation of patients who did and did not do preoperative abdominal breathing exercises.', 'detailedDescription': 'The respiratory type and pattern of all patients will be recorded before gallbladder surgery.\n\nIn Group P, abdominal breathing training will be given to the patients in this group. They will perform abdominal breathing for at least 5 minutes 6 times a day until surgery.\n\nIn Group C,patients who are not given abdominal breathing.\n\nIn the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, NRS scores of the patients will be evaluated (in the recovery room, 1,2,6,12 and 24 hours.\n\nPreoperative anxiety, postoperative discharge time and analgesic consumption of all patients will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Gallbladder surgerysurgery patients who will be operated under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned to gall bladder surgery\n* An American Society of Anesthesiologists score of 1,2 or 3\n\nExclusion Criteria:\n\n* Severe cardiovascular disease\n* Respiratory disease\n* Psychiatric disease\n* Those who have chronic pain'}, 'identificationModule': {'nctId': 'NCT05334160', 'briefTitle': 'Pain and Abdominal Breathing Exercises', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'Evaluation of the Postoperative Effects of Preoperative Abdominal Breathing Exercises in Laparoscopic Cholecystectomy Operations', 'orgStudyIdInfo': {'id': '21-KAEK-230'}}, 'contactsLocationsModule': {'locations': [{'zip': '60200', 'city': 'Tokat Province', 'country': 'Turkey (Türkiye)', 'facility': 'Hakan Tapar', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Hakan Tapar', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}