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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02765932
Other study ID # 16-00712
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date March 5, 2018

Study information

Verified date October 2018
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 5, 2018
Est. primary completion date March 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient undergoing joint replacement surgery (Hip and Knee Only)

- Patient is willing to participate in pre- and postoperative surveys

Exclusion Criteria:

- Patients who have undergone joint replacement surgeries

- History of Chronic Narcotic Use (more than 30mg morphine dose)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Dummy Movements
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.
Psychosensory Therapy
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.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain from baseline using Visual Analogue Score (VAS) Measures level of Pain pre and post treatment. Baseline and 7 Months
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