The Effect of a Psychosensory Therapy
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 9, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2018
CompletedOctober 22, 2018
October 1, 2018
1.8 years
May 4, 2016
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain from baseline using Visual Analogue Score (VAS)
Measures level of Pain pre and post treatment.
Baseline and 7 Months
Study Arms (2)
Placebo Therapy
ACTIVE COMPARATORDummy Movements
Psychosensory Therapy
EXPERIMENTALWill involve touch technique, havening.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient undergoing joint replacement surgery (Hip and Knee Only)
- Patient is willing to participate in pre- and postoperative surveys
You may not qualify if:
- Patients who have undergone joint replacement surgeries
- History of Chronic Narcotic Use (more than 30mg morphine dose)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ran Schwarzkopf, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 9, 2016
Study Start
June 1, 2016
Primary Completion
March 5, 2018
Study Completion
March 5, 2018
Last Updated
October 22, 2018
Record last verified: 2018-10