An interventional study of hypnosis therapy in Anxiety and Opioid Use, sponsored by Foundation for Orthopaedic Research and Education. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Foundation for Orthopaedic Research and Education · Not applicable, Interventional, and Supportive care
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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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 144 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Foundation for Orthopaedic Research and Education is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: hypnosis therapy
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.
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.
Also known as: hypnotherapy
Change in Perioperative Anxiety
Patient-reported anxiety in the perioperative period
Time frame: 7 days before surgery, day of surgery, 7 days after surgery
Change in Perioperative Pain
Patient-reported pain in the perioperative period
Time frame: 7 days before surgery, day of surgery, 7 days after surgery
Change in Opioid Consumption
Patient-reported opioid consumption in the perioperative period
Time frame: 7 days after surgery, postoperative day 10, postoperative day 49
Change in Anxiolytic Consumption
Patient-reported opioid consumption in the perioperative period
Time frame: 7 days after surgery, postoperative day 10, postoperative day 49
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Dec 2023, 35 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 35 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Foundation for Orthopaedic Research and Education