The Effect of a Psychosensory Therapy

The Effect of a Psychosensory Therapy on Post-Op Pain in Hip and Knee Surgery: A Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Joint Replacement Surgery
• Intervention / Treatment: Procedure: Dummy Movements; Procedure: Psychosensory Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo Therapy; Dummy Movements	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.
Experimental: Psychosensory Therapy; Will involve touch technique, havening.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain from baseline using Visual Analogue Score (VAS)	Measures level of Pain pre and post treatment.	Baseline and 7 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ran Schwarzkopf, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): March 5, 2018

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (Estimate): May 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: surgery; Knee; Hip; replacement
• Other Study ID Numbers: 16-00712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No