Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
Study NCT ID:
NCT04288492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2020-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Biofeedback on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total score of STAI(state-trait anxiety inventory)', 'timeFrame': '20 minutes before the anesthesia started.', 'description': 'Preoperative anxiety state is measured using STAI(state-trait anxiety inventory): Total score of 40 questions.\n\nEach question is consisted as follows\n\n1: not at all 2: a little 3: somewhat 4: very much so minimal: 40 maximum: 160'}], 'secondaryOutcomes': [{'measure': 'Total amount of cumulative analgesics', 'timeFrame': '24 hours after the anesthesia finished.', 'description': 'total amount of analgesics are measured for 24 hours after surgery.'}, {'measure': 'The rate of Pulmonary complication', 'timeFrame': '24 hours after the anesthesia finished.', 'description': 'medical record is checked after operation'}, {'measure': 'The score of pain', 'timeFrame': '24 hours after the anesthesia finished.', 'description': 'VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory biofeedback', 'Postpoerative Pain', 'Preoperative Anxiety'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, randomized, controlled, double-blinded, and parallel design study. A total of 106 patients were decided to be recruited considering a 10% dropout rate. Patients are randomizes to perform or not respiratory exercises using biofeedback device(ResCalm). The randomization numbers are generated using a computer-generated randomization code and are sealed in the opaque envelope until they are handed over to anesthesiologist in charge of patient management. Record patient preoperative t anxiety, postoperative pain, and pain medication use. Patient aged 19-64 yr, ASA class 1 or 2, and are scheduled for elective laparoscopic cholecystectomy are included. Patients who were unable to perform self breathing at regular intervals were excluded.', 'detailedDescription': "1. Assignment of experimental groups\n\n Group A: Respiratory exercise using respiratory biofeedback device(ResCalm) is applied 2-3 times / day for 3 minutes until discharge from hospital and once in the recovery room before surgery.\n\n Group B: General surgery schedule without control exercise.\n\n All patients measure STAI(state trait anxiety inventory) at the operating room entrance on the day of surgery.\n2. anesthesia methods Intravenous anesthesia is performed using the target injection concentration control method. As an anesthetic, propofol / remifentanil / rocuronium is used. The artificial ventilation method is a pressure-controlled ventilation method, which maintains an appropriate pressure and performs anesthesia.\n3. postoperative care After anesthesia, the patient wakes up and transfers to the recovery room to encourage self-breathing exercise. After entering the recovery room, the patient's vital signs (average blood pressure, heart rate, oxygen saturation) and analgesic use are checked immediately before leaving.\n\nThe investigators check for the presence of pulmonary complications, visual analog scale (VAS), analgesic use, and hospital patient satisfaction for 24 hours after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged between 19 and 64 years of age with ASA class I, II who underwent regular laparoscopic cholecystectomy under general anesthesia.\n\nExclusion Criteria:\n\n* Seniors 65 years of age or older or minors under 19 years of age\n* ASA (American Society of Anesthesiologists) class ≥ III\n* Difficulties in proper cooperation with diseases such as Alzheimer dementia, cognitive disorders, and psychopathy\n* Patients with respiratory diseases such as Asthma, Pnuemonia\n* Patients with incomplete airway due to pulmonary resection, airway surgery, mouth or nose surgery'}, 'identificationModule': {'nctId': 'NCT04288492', 'briefTitle': 'Effect of Biofeedback on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Effect of Respiratory Exercise Using Preoperative Biofeedback on Postoperative Pain', 'orgStudyIdInfo': {'id': 'biofeedback112233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'biofeedback', 'description': 'Respiratory exercise using biofeedback device(ResCalm) 2-3 times / day for 3 minutes until discharge from hospital, once in recovery room before surgery', 'interventionNames': ['Behavioral: Respiratory biofeedback']}, {'type': 'NO_INTERVENTION', 'label': 'general', 'description': 'General surgical schedule without control exercise'}], 'interventions': [{'name': 'Respiratory biofeedback', 'type': 'BEHAVIORAL', 'description': 'Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)', 'armGroupLabels': ['biofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13590', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Bon Wook Koo', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Bon Wook Koo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SNUBH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistnat professosr', 'investigatorFullName': 'BON WOOK KOO', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}