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Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

NCT04889833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-04-01

No results posted yet for this study

Summary

The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.

Conditions

Interventions

BEHAVIORAL

hypnosis therapy

Pre-recorded hypnosis therapy audio recording with accompanying visual of a calm ocean to be played at least once daily for 7 preoperative days, the day of surgery, and for 7 days postoperatively.

Sponsors & Collaborators

  • Foundation for Orthopaedic Research and Education

    lead OTHER

Principal Investigators

  • Mark A Frankle, MD · Florida Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-19
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889833 on ClinicalTrials.gov