Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-02 @ 6:39 PM
Study NCT ID:
NCT06978335
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-28
First Post:
2025-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupoint Stimulation Improves Postoperative Wound Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-11', 'studyFirstSubmitQcDate': '2025-05-11', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total Analgesic Consumption Within 72 Hours After Surgery', 'timeFrame': 'Within 72 hours after surgery', 'description': 'This outcome evaluates whether acupoint stimulation reduces the need for postoperative analgesics.'}, {'measure': 'Time to First Ambulation After Surgery', 'timeFrame': 'Within 72 hours after surgery', 'description': 'Time from completion of surgery to the first successful ambulation will be recorded. Recorded as an indicator of overall postoperative mobility and functional recovery.'}], 'primaryOutcomes': [{'measure': 'Pain Intensity Measured by Visual Analog Scale (VAS)', 'timeFrame': 'At 1, 4, 12, 24, 48, and 72 hours post-surgery', 'description': 'Pain intensity will be assessed using the Visual Analog Scale (VAS). The primary analysis will focus on changes in pain intensity over time between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Pain Impact Assessed by Brief Pain Inventory - Taiwan Version (BPI-Taiwan)', 'timeFrame': 'On postoperative Day 3', 'description': 'The Brief Pain Inventory - Taiwan version (BPI-Taiwan) will be used to assess the impact of pain on various aspects of daily functioning. Total and subscale scores will be analyzed to evaluate differences in pain interference between the two groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupoint stimulation', 'postoperative pain'], 'conditions': ['Abdominal Surgeries', 'Pain', 'Acupuncture Points']}, 'descriptionModule': {'briefSummary': 'Postoperative pain remains one of the most common and distressing symptoms experienced by surgical patients. Poorly managed postoperative pain can impede recovery, reduce patient willingness to mobilize, increase the risk of complications, and negatively affect overall quality of life. Currently, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are the primary pharmacological strategies for managing postoperative pain. However, these medications often carry the risk of adverse effects and may not adequately address all aspects of patient comfort and recovery.\n\nIn response to this challenge, this study aims to evaluate the effects of a non-pharmacological, non-invasive intervention-acupoint stimulation-on postoperative wound pain and mobilization in patients undergoing abdominal surgery. Ultimately, this study seeks to contribute to the development of more diversified and patient-centered pain management strategies, with the expectation that the integration of Chinese and Western medicine will lead to improved patient care and enhanced postoperative recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Surgical wound length ≥ 10 cm\n* American Society of Anesthesiologists (ASA) physical status classification I to III\n* Receiving intravenous patient-controlled analgesia (IV PCA)\n* Clear consciousness and ability to communicate\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Presence of arrhythmia\n* Implanted artificial cardiac pacemaker\n* Cutaneous lesions at the acupoint or auricular application sites\n* History of chronic pain or abdominal surgery within the past 6 months\n* Non-ambulatory status prior to surgery'}, 'identificationModule': {'nctId': 'NCT06978335', 'briefTitle': 'Acupoint Stimulation Improves Postoperative Wound Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cheng-Hsin General Hospital'}, 'officialTitle': 'Acupoint Stimulation Intervention Improves Postoperative Wound Pain and Mobility in Patients With Abdominal Surgery', 'orgStudyIdInfo': {'id': '(1090)113A-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Acupoint Stimulation', 'description': 'Acupoint stimulation was administered on six points and auricular points on three points on the left ear, additional auricular points were selected according to the abdominal organ involved in surgery and its corresponding meridian representation on the auricle.', 'interventionNames': ['Other: Acupoint Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control: Sham Acupoint Stimulation', 'interventionNames': ['Other: Sham Acupoint Stimulation']}], 'interventions': [{'name': 'Acupoint Stimulation', 'type': 'OTHER', 'description': 'This intervention involves acupoint stimulation and auricular acupressure. Stimulation of selected body acupoints is administered by trained personnel following a standardized protocol. The intervention is provided once daily for three consecutive days, beginning post-surgery. For auricular acupressure, additional auricular points are chosen based on the involved abdominal organ and its corresponding viscera-meridian locations on the auricle. Vaccaria seeds are applied to the selected points with adhesive patches, and patients are instructed to apply pressure to the points regularly throughout the day.', 'armGroupLabels': ['Experimental: Acupoint Stimulation']}, {'name': 'Sham Acupoint Stimulation', 'type': 'OTHER', 'description': 'Participants in this group will receive a sham acupoint stimulation procedure. Acupoint stimulation will be using identical procedures to the experimental group, without applying pressure. No stimulation or manipulation was performed. The frequency and timing of the sham intervention matched that of the experimental group.', 'armGroupLabels': ['Control: Sham Acupoint Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'state': 'Peitou Dist', 'country': 'Taiwan', 'facility': 'Cheng Hsin General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cheng-Hsin General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}