Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-03-12 @ 8:00 PM
Study NCT ID:
NCT02765932
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2016-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Psychosensory Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2016-05-06', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain from baseline using Visual Analogue Score (VAS)', 'timeFrame': 'Baseline and 7 Months', 'description': 'Measures level of Pain pre and post treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip', 'Knee', 'replacement', 'surgery'], 'conditions': ['Joint Replacement Surgery']}, 'descriptionModule': {'briefSummary': 'This is a prospective study looking at the impact of psychosensory therapy and how it can diminish pain and consumption of pain medications. The primary study objective is to evaluate the change in Visual Analogue Score (VAS) score assessing for pain from Baseline, every day of inpatient stay, 7 days after leaving hospital (via phone), and 3 months post-op(via phone) and to correlate the psychosensory therapy and overall use of pain medications/narcotics.', 'detailedDescription': 'The study will aim to enroll 50 subjects. 25 subjects will receive placebo therapy which will be dummy movements while the other 25 will receive psychosensory therapy. The treatment group will involve a touch technique called havening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing joint replacement surgery (Hip and Knee Only)\n* Patient is willing to participate in pre- and postoperative surveys\n\nExclusion Criteria:\n\n* Patients who have undergone joint replacement surgeries\n* History of Chronic Narcotic Use (more than 30mg morphine dose)'}, 'identificationModule': {'nctId': 'NCT02765932', 'briefTitle': 'The Effect of a Psychosensory Therapy', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'The Effect of a Psychosensory Therapy on Post-Op Pain in Hip and Knee Surgery: A Randomized Study', 'orgStudyIdInfo': {'id': '16-00712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo Therapy', 'description': 'Dummy Movements', 'interventionNames': ['Procedure: Dummy Movements']}, {'type': 'EXPERIMENTAL', 'label': 'Psychosensory Therapy', 'description': 'Will involve touch technique, havening.', 'interventionNames': ['Procedure: Psychosensory Therapy']}], 'interventions': [{'name': 'Dummy Movements', 'type': 'PROCEDURE', 'description': 'The placebo group will be asked to perform the same touch technique and count backwards from 50 while removing petals from a flower. Patients will also perform these techniques before rehab and sleep.', 'armGroupLabels': ['Placebo Therapy']}, {'name': 'Psychosensory Therapy', 'type': 'PROCEDURE', 'description': 'The research assistant will administer one of the several psychosensory touch techniques prior to surgery. This will involve the touching of upper arms, palms, and a visualization process. This will last no longer than 10 minutes. These techniques will also be performed by the patients prior to any rehab sessions and before going to sleep. The patients will be asked to perform these touch techniques with the eyes closed and imaging having no pain. The patients will also be asked to keep a record of all medications.', 'armGroupLabels': ['Psychosensory Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ran Schwarzkopf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}