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Hypnosis Therapy for Shoulder Replacement Therapy

N/A
Waitlist Available
Led By Mark A Frankle, 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 before surgery, day of surgery, 7 days after surgery
Awards & highlights

Study Summary

This trial is studying whether hypnosis can help relieve pain and anxiety during and after major surgery.

Eligible Conditions
  • Anxiety
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days before surgery, day of surgery, 7 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days before surgery, day of surgery, 7 days after surgery 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 Opioid Consumption
Change in Perioperative Anxiety
Change in Perioperative Pain
Secondary outcome measures
Change in Anxiolytic Consumption

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hypnosis Therapy GroupExperimental Treatment1 Intervention
Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, & shoulder function. 7 days before surgery, they will receive a pre-recorded video (~19 min) of guided hypnosis to be watched at least 1x/day, until surgery. Before & after the video, they will rate pain/anxiety levels. On the day of surgery, they will watch the video again & answer questions about their average anxiety and pain level. After surgery, they will watch the video each day and report on pain/anxiety, medication use, satisfaction, and sleep disturbance until postoperative day 7. 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 shoulder arthroplasty patient regardless of study participation.
Group II: Usual Care GroupActive Control1 Intervention
Patients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, & shoulder function. 7 days before surgery, they will receive a daily questionnaire about their pain & anxiety over the last 24 hours. On the day of surgery, before they are given any anesthesia, they will answer questions about their average anxiety & pain levels. Starting the next morning on the day following surgery and every day for the subsequent week, they will be given questionnaires about their pain & anxiety levels, medication use, satisfaction, and sleep disturbance due to pain. Their postoperative course will be otherwise completely standard of care, including a first postoperative clinic visit at 10 days after surgery, where the patients will be given these same questionnaires. Finally, patients will answer them one more time on postoperative day 49 and this will constitute a study endpoint. The whole process each day should take approximately 10 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hypnosis therapy
2020
N/A
~150

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
Mark A Frankle, MDPrincipal InvestigatorFlorida Orthopaedic Institute

Media Library

hypnosis therapy Clinical Trial Eligibility Overview. Trial Name: NCT04889833 — N/A
Anxiety Research Study Groups: Usual Care Group, Hypnosis Therapy Group
Anxiety Clinical Trial 2023: hypnosis therapy Highlights & Side Effects. Trial Name: NCT04889833 — N/A
hypnosis therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04889833 — N/A
~33 spots leftby Jun 2025
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