Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT02762435
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2016-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupressure in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}, {'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Recovery score', 'timeFrame': 'Time Frame: Day 0, Day 2', 'description': 'The validated QOR15 score will be assessed at baseline (Day 0) and after the 6 sessions have been completed (Day 2) and the change in QOR15 (Day 2 minus Day 0) will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acupressure']}, 'referencesModule': {'references': [{'pmid': '30985537', 'type': 'DERIVED', 'citation': 'Noll E, Shodhan S, Romeiser JL, Madariaga MC, Page C, Santangelo D, Guo X, Pryor AD, Gan TJ, Bennett-Guerrero E. Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):557-565. doi: 10.1097/EJA.0000000000001001.'}, {'pmid': '28270180', 'type': 'DERIVED', 'citation': 'Noll E, Shodhan S, Madariaga MC, Page CR, Santangelo D, Guo X, Al Bizri E, Pryor AD, Romeiser J, Bennett-Guerrero E. Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial. Trials. 2017 Mar 7;18(1):110. doi: 10.1186/s13063-017-1839-1.'}]}, 'descriptionModule': {'briefSummary': 'After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control, sham, accupressure (3 points on the hand and wrist three times per day). Quality of recovery and other measures of patient satisfaction will be recorded.', 'detailedDescription': 'After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control (no touch), sham (light touch), acupressure (2 minutes moderate pressure each at PC6, LI4, and HT7 three times per day). Quality of recovery using the validated Quality of Recovery (QOR) 15 score and other measures of patient satisfaction (nausea score, pain score) will be recorded at baseline and after their 6 study sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adults\n2. patients at Stony Brook hospital\n3. expected to be hospitalized for at least 3 days\n4. able to sign informed consent and participate in the study\n\nExclusion Criteria:\n\n1. Under 18 years of age\n2. Do not have access to the 3 points on the hand and wrist due to skin breakdown, ulcers, cellulitis, broken bone, indwelling catheter within 5 cm radius of the pressure points.\n3. Significant dementia or altered mental status that would prevent assessment of the QOR survey\n4. Allergic reaction to ink\n5. Stroke or other neurologic condition which precludes sensation in both upper extremities.\n6. Ongoing use of regional anesthetic technique\n7. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02762435', 'briefTitle': 'Acupressure in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Randomized Controlled Trial of Acupressure to Improve Patient Satisfaction and Quality of Recovery in Hospitalized Patients', 'orgStudyIdInfo': {'id': '867005-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'No pressure applied to the 3 points', 'interventionNames': ['Other: control']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham', 'description': 'Light touch applied to the 3 points (2 minutes each at PC6, LI4, and HT7, three times per day for 2 days)', 'interventionNames': ['Other: sham']}, {'type': 'EXPERIMENTAL', 'label': 'acupressure', 'description': 'Moderate pressure applied to the 3 points (2 minutes each at PC6, LI4, and HT7, three times per day for 2 days)', 'interventionNames': ['Other: acupressure']}], 'interventions': [{'name': 'sham', 'type': 'OTHER', 'description': 'light touch at established points on hand and wrist', 'armGroupLabels': ['sham']}, {'name': 'control', 'type': 'OTHER', 'description': 'no contact with the subject', 'armGroupLabels': ['control']}, {'name': 'acupressure', 'type': 'OTHER', 'description': 'moderate pressure at established points on hand and wrist', 'armGroupLabels': ['acupressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794-8480', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Medicine', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Elliott Bennett-Guerrero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}