Hypnosis for Symptom Management in Elective Orthopedic Surgery

Postoperative Pain Clinical Trial

Official title:

A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308071
• Other study ID #: IRB-41122
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: August 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of admission.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypnosis
• Knee Arthroplasty, Total
• Perioperative Care
• Postoperative Complications
• Postoperative Pain

Intervention

Behavioral:
• Hypnosis
Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.

Locations

Country	Name	City	State
United States	Stanford University/Stanford Healthcare	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic use	Total narcotic use during the hospital stay will be calculated in "morphine equivalents"	Index hospitalization for total knee replacement, average 2-3 days
Secondary	Narcotic prescriptions	Total narcotics prescribed in the outpatient setting	1 month before, and 3 months and 1 year after joint replacement
Secondary	Narcotic-associated side effects	Incidence of delirium, constipation, urinary retention, respiratory depression	Index hospitalization for total knee replacement, average 2-3 days
Secondary	UCLA activity scores	Classifies the activity level of joint replacement patients	At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Secondary	KOOS Jr Survey	Knee injury and osteoarthritis outcome score	At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Secondary	VR-12 Survey	Measures health-related quality of life	At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
Secondary	Knee Society Score	Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)	At the pre-op visit with the surgeon and 12 weeks post-op
Secondary	Number of days hospitalized	Total number of days hospitalized for total knee replacement surgery	Reported once , after patient is discharged (1 day)
Secondary	Satisfaction with hypnosis survey	Attitudes and expectations regarding hypnosis	Pre-op and 2 weeks post-op