AnxietyNCT04889833
Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy
A study testing hypnosis therapy in people with Anxiety and Opioid Use, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Opioid Use
- What is being tested?
- hypnosis therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of primary shoulder osteoarthritis, massive cuff tear arthropathy, and rotator cuff arthropathy requiring a primary total or reverse shoulder replacement,
- the ability to read, speak, and understand English
- the ability and willingness to use a web-based application (OBERD) on a smartphone, pad, or computer, and
- 18 years of age or older.
Who cannot join
- shoulder replacement for the treatment of acute proximal humerus fractures
- hemiarthroplasty
- revision shoulder replacement
- patients with active cancer or receiving palliative care
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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
- Anxiety, Opioid Use
- Being tested
- hypnosis therapy
- Keywords
- hypnosis, shoulder arthroplasty
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosis therapyBehavioural
Also called hypnotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Therapy Group | Experimental | 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. Receives: Behavioral: hypnosis therapy |
| Usual Care Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perioperative Anxiety
Patient-reported anxiety in the perioperative period
Measured: 7 days before surgery, day of surgery, 7 days after surgery
Change in Perioperative Pain
Patient-reported pain in the perioperative period
Measured: 7 days before surgery, day of surgery, 7 days after surgery
Change in Opioid Consumption
Patient-reported opioid consumption in the perioperative period
Measured: 7 days after surgery, postoperative day 10, postoperative day 49
Secondary outcomes (1)
Change in Anxiolytic Consumption
Patient-reported opioid consumption in the perioperative period
Measured: 7 days after surgery, postoperative day 10, postoperative day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start19 Dec 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Frankle, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889833
- Sponsor's protocol ID
- 1.0 - 20203698
- Status last verified
- Mar 2024
- First submitted
- 7 May 2021
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy
- ClinicalTrials.gov ID
- NCT04889833
- Acronym / sponsor ID
- 1.0 - 20203698
- Conditions
- Anxiety, Opioid Use
- Keywords
- hypnosis, shoulder arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Study start
- 19 Dec 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Therapy Group | Experimental | Behavioral: hypnosis therapyPatients 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. |
| Usual Care Group | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of primary shoulder osteoarthritis, massive cuff tear arthropathy, and rotator cuff arthropathy requiring a primary total or reverse shoulder replacement,
- the ability to read, speak, and understand English
- the ability and willingness to use a web-based application (OBERD) on a smartphone, pad, or computer, and
- 18 years of age or older.
Key exclusion criteria (5 listed)
- shoulder replacement for the treatment of acute proximal humerus fractures
- hemiarthroplasty
- revision shoulder replacement
- patients with active cancer or receiving palliative care
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnosis therapyAlso: hypnotherapyPre-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. | Behavioural | Hypnosis Therapy Group |
Primary outcome
Change in Perioperative Anxiety
Time frame: 7 days before surgery, day of surgery, 7 days after surgery
Patient-reported anxiety in the perioperative period
Change in Perioperative Pain
Time frame: 7 days before surgery, day of surgery, 7 days after surgery
Patient-reported pain in the perioperative period
Change in Opioid Consumption
Time frame: 7 days after surgery, postoperative day 10, postoperative day 49
Patient-reported opioid consumption in the perioperative period
1 secondary outcome
Change in Anxiolytic Consumption
Time frame: 7 days after surgery, postoperative day 10, postoperative day 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Frankle, MD principal investigator
Florida Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis therapy in people with Anxiety and Opioid Use, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perioperative Anxiety (time frame: 7 days before surgery, day of surgery, 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.