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Hypnosis Therapy for Knee Surgery Recovery

N/A

Recruiting

Led By Brian T Palumbo, MD

Research Sponsored by Foundation for Orthopaedic Research and Education

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

Awards & highlights

Study Summary

This trial looks at how hypnosis therapy may reduce post-op pain & opioid use in major orthopaedic surgery. Patients are randomly assigned to usual care or hypnosis treatment.

Who is the study for?

This trial is for adults over 18 who need a knee replacement due to arthritis, can communicate in English, and are willing to use a web app for the study. It's not open to those needing revision surgery or with active cancer.Check my eligibility

What is being tested?

The study tests if hypnosis therapy during the perioperative period can reduce anxiety-related pain and lower opioid use after knee replacement surgery. Participants will either receive usual care or hypnotherapy treatment at random.See study design

What are the potential side effects?

Hypnosis therapy is generally considered safe but may cause temporary side effects like dizziness, headache, drowsiness, or anxiety in some individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days prior to surgery, 10 days postoperative day, 49 days postoperative day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)

Secondary outcome measures

Change in Anxiolytic Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client

Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client

Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypnosis Therapy GroupExperimental Treatment1 Intervention

Experimental: Hypnosis Therapy Group Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, & knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided hypnosis to be watched at least 1x/day, until surgery. Postoperative course will be otherwise completely standard of care, including a clinic visit at 10 days after surgery, where they will be given these same questionnaires. Patients will answer them again on postoperative day 49, constituting a study endpoint. Access to pain medication & study doctor will be the same as any total knee arthroplasty regardless of study participation.

Group II: Control Care GroupActive Control1 Intervention

No Intervention: Control Care Group Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, & knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided information to be watched at least 1x/day, until surgery. Postoperative course will be otherwise completely standard of care, including a clinic visit at 10 days after surgery, where they will be given these same questionnaires. Patients will answer them again on postoperative day 49, constituting a study endpoint. Access to pain medication & study doctor will be the same as any total knee arthroplasty regardless of study participation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypnosis Therapy

2014

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Foundation for Orthopaedic Research and EducationLead Sponsor

13 Previous Clinical Trials

938 Total Patients Enrolled

1 Trials studying Anxiety

144 Patients Enrolled for Anxiety

Brian T Palumbo, MDPrincipal InvestigatorFlorida Orthopaedic Institute

Media Library

Hypnosis Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05818969 — N/A

Anxiety Research Study Groups: Hypnosis Therapy Group, Control Care Group

Anxiety Clinical Trial 2023: Hypnosis Therapy Highlights & Side Effects. Trial Name: NCT05818969 — N/A

Hypnosis Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05818969 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant cap for this clinical research?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is presently recruiting patients who were initially invited to participate on February 1st 2022 and was most recently updated on April 5th 2023. The research team needs 144 individuals across one location for the study."

Answered by AI

Are there any opportunities for patients to take part in this clinical experiment?

"Indeed, according to clinicaltrials.gov the recruitment phase of this medical trial is ongoing. It was first posted on February 1st 2022 and has since been updated in April 5th 2023. A total of 144 patients must be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

2022. "Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05818969.

All > Knee Replacement