HypnosisNCT03308071
Hypnosis for Symptom Management in Elective Orthopedic Surgery
A study testing Hypnosis in people with Hypnosis and Perioperative Care, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to determine if teaching self-hypnosis techniques to patients prior to knee replacement surgery will decrease their pain medication requirements, pain medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety, physical function, satisfaction scores, and cost… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypnosis, Perioperative Care, Knee Arthroplasty, Total
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 30 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- scheduled for a primary, unilateral, total knee replacement surgery within the study period
- able to commit to a single study clinic visit at least one week prior to their scheduled surgery and use of phone recordings
- able to read and understand English
- Score at least 25 on mini-mental state exam
Who cannot join
- severe psychiatric or structural brain disease (ie. psychosis, stroke with functional impairment, dementia)
- current use of hypnosis/self-hypnosis
- enrolled in other clinical trials related to pain management or length of stay
- hearing impairment that would impede ability to listen to a phone recording
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University/Stanford Healthcare
Palo Alto, California, 94305
About this study
Official title: A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery
The purpose of the study is to determine if teaching self-hypnosis techniques to patients prior to knee replacement surgery will decrease their pain medication requirements, pain medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety, physical function, satisfaction scores, and cost of admission.
Read the detailed description
Patients will be recruited by through orthopedic surgery clinics or contacted by after pre-screening via chart review and given an information brochure. If they are interested in the trial will be emailed or given a paper copy of the consent form and scheduled for a single additional visit in the Integrative Medicine Center at Hoover Pavilion approximately 1 week before surgery. At the single study visit, participants would be consented, then a mini-mental state test would be performed to determine if participants are eligible by a score of 25 or above. If eligible, participants would be asked to fill out surveys relating to demographics, attitudes and experience with hypnosis, and detailed pain medication usage. Then, participants would be randomized to hypnosis vs. no hypnosis. The hypnosis group will undergo a Hypnotic Induction Profile to score hypnotizability, then be lead through a hypnosis induction and read a perioperative symptom management script, then re-alerted from hypnosis. Patients in this group would then be asked to listen to the same hypnosis script on a telephone recording twice per day until after the surgery when participants feel they don't need it anymore.
The control group will fill out the surveys and the study visit will end. Participants will be asked not to use any hypnosis until the trial period is over. Data regarding pain, activity, and satisfaction is already collected by email survey or by Ipad in orthopedic clinic at or before the pre-op visit, and 3 months post-op.
Patients in the knee study will be asked to fill out the same surveys around the two week and six week post-op orthopedic clinic visits as well. One additional survey will be added at the 2 week post-op visit to reassess attitudes and experience with hypnosis, and detailed pain medication usage. Those participants who do not fill out the survey will be called and/or emailed to remind them to fill it out.
- Conditions
- Hypnosis, Perioperative Care, Knee Arthroplasty, Total, Postoperative Pain, Postoperative Complications
- Being tested
- Hypnosis
- Keywords
- Hypnosis, Hypnotherapy, Perioperative Pain Management, Narcotic reduction, Perioperative Outcomes, Total knee replacement, Total knee arthroplasty
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Group | Experimental | Participants will undergo a brief hypnotic assessment, a single hypnosis session with an MD trained in hypnosis, and be given a phone number to listen to a guided self-hypnosis recording for 1 week pre-op until 2 weeks post-op. Receives: Behavioral: Hypnosis |
| Usual care | No intervention | These patients will be enrolled in the study and usual care will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic use
Total narcotic use during the hospital stay will be calculated in "morphine equivalents"
Measured: Index hospitalization for total knee replacement, average 2-3 days
Secondary outcomes (8)
Narcotic prescriptions
Total narcotics prescribed in the outpatient setting
Measured: 1 month before, and 3 months and 1 year after joint replacement
Narcotic-associated side effects
Incidence of delirium, constipation, urinary retention, respiratory depression
Measured: Index hospitalization for total knee replacement, average 2-3 days
UCLA activity scores
Classifies the activity level of joint replacement patients
Measured: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
KOOS Jr Survey
Knee injury and osteoarthritis outcome score
Measured: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
VR-12 Survey
Measures health-related quality of life
Measured: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Knee Society Score
Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)
Measured: At the pre-op visit with the surgeon and 12 weeks post-op
Number of days hospitalized
Total number of days hospitalized for total knee replacement surgery
Measured: Reported once , after patient is discharged (1 day)
Satisfaction with hypnosis survey
Attitudes and expectations regarding hypnosis
Measured: Pre-op and 2 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start20 Sep 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypnosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie Kittle, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308071
- Sponsor's protocol ID
- IRB-41122
- Status last verified
- Aug 2021
- First submitted
- 23 Jun 2017
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Markovits J, Blaha O, Zhao E, Spiegel D. Effects of hypnosis versus enhanced standard of care on postoperative opioid use after total knee arthroplasty: the HYPNO-TKA randomized clinical trial. Reg Anesth Pain Med. 2022 Jun 17:rapm-2022-103493. doi: 10.1136/rapm-2022-103493. Online ahead of print.
PubMed 35715013
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03308071
- Acronym / sponsor ID
- IRB-41122
- Conditions
- Hypnosis, Perioperative Care, Knee Arthroplasty, Total, Postoperative Pain, Postoperative Complications
- Keywords
- Hypnosis, Hypnotherapy, Perioperative Pain Management, Narcotic reduction, Perioperative Outcomes, Total knee replacement, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 12 Oct 2017 (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 the study is to determine if teaching self-hypnosis techniques to patients prior to knee replacement surgery will decrease their pain medication requirements, pain medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety, physical function, satisfaction scores, and cost of admission.
Detailed description
Patients will be recruited by through orthopedic surgery clinics or contacted by after pre-screening via chart review and given an information brochure. If they are interested in the trial will be emailed or given a paper copy of the consent form and scheduled for a single additional visit in the Integrative Medicine Center at Hoover Pavilion approximately 1 week before surgery. At the single study visit, participants would be consented, then a mini-mental state test would be performed to determine if participants are eligible by a score of 25 or above. If eligible, participants would be asked to fill out surveys relating to demographics, attitudes and experience with hypnosis, and detailed pain medication usage. Then, participants would be randomized to hypnosis vs. no hypnosis. The hypnosis group will undergo a Hypnotic Induction Profile to score hypnotizability, then be lead through a hypnosis induction and read a perioperative symptom management script, then re-alerted from hypnosis. Patients in this group would then be asked to listen to the same hypnosis script on a telephone recording twice per day until after the surgery when participants feel they don't need it anymore.
The control group will fill out the surveys and the study visit will end. Participants will be asked not to use any hypnosis until the trial period is over. Data regarding pain, activity, and satisfaction is already collected by email survey or by Ipad in orthopedic clinic at or before the pre-op visit, and 3 months post-op.
Patients in the knee study will be asked to fill out the same surveys around the two week and six week post-op orthopedic clinic visits as well. One additional survey will be added at the 2 week post-op visit to reassess attitudes and experience with hypnosis, and detailed pain medication usage. Those participants who do not fill out the survey will be called and/or emailed to remind them to fill it out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Group | Experimental | Behavioral: HypnosisParticipants will undergo a brief hypnotic assessment, a single hypnosis session with an MD trained in hypnosis, and be given a phone number to listen to a guided self-hypnosis recording for 1 week pre-op until 2 weeks post-op. |
| Usual care | No intervention | –These patients will be enrolled in the study and usual care will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old.
- scheduled for a primary, unilateral, total knee replacement surgery within the study period
- able to commit to a single study clinic visit at least one week prior to their scheduled surgery and use of phone recordings
- able to read and understand English
- Score at least 25 on mini-mental state exam
Key exclusion criteria (4 listed)
- severe psychiatric or structural brain disease (ie. psychosis, stroke with functional impairment, dementia)
- current use of hypnosis/self-hypnosis
- enrolled in other clinical trials related to pain management or length of stay
- hearing impairment that would impede ability to listen to a phone recording
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 |
|---|---|---|
| HypnosisHypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered. | Behavioural | Hypnosis Group |
Primary outcome
Narcotic use
Time frame: Index hospitalization for total knee replacement, average 2-3 days
Total narcotic use during the hospital stay will be calculated in "morphine equivalents"
8 secondary outcomes
Narcotic prescriptions
Time frame: 1 month before, and 3 months and 1 year after joint replacement
Narcotic-associated side effects
Time frame: Index hospitalization for total knee replacement, average 2-3 days
UCLA activity scores
Time frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
KOOS Jr Survey
Time frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
VR-12 Survey
Time frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Knee Society Score
Time frame: At the pre-op visit with the surgeon and 12 weeks post-op
Number of days hospitalized
Time frame: Reported once , after patient is discharged (1 day)
Satisfaction with hypnosis survey
Time frame: Pre-op and 2 weeks post-op
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 25 Aug 2021.
- Derived from this study: PubMed 35715013Markovits J, Blaha O, Zhao E, Spiegel D. Effects of hypnosis versus enhanced standard of care on postoperative opioid use after total knee arthroplasty: the HYPNO-TKA randomized clinical trial. Reg Anesth Pain Med. 2022 Jun 17:rapm-2022-103493. doi: 10.1136/rapm-2022-103493. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Hypnosis and Perioperative Care, run by Stanford University 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 5 inclusion and 4 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 25 Aug 2021. 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?
Narcotic use (time frame: Index hospitalization for total knee replacement, average 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308071, which also lists 1 linked publication.
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 25 Aug 2021.