NCT03308071

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

June 23, 2017

Last Update Submit

August 23, 2021

Conditions

HypnosisPerioperative CareKnee Arthroplasty, TotalPostoperative PainPostoperative Complications

Keywords

HypnosisHypnotherapyPerioperative Pain ManagementNarcotic reductionPerioperative OutcomesTotal knee replacementTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Narcotic prescriptions

    1 month before, and 3 months and 1 year after joint replacement

  • Narcotic-associated side effects

    Index hospitalization for total knee replacement, average 2-3 days

  • UCLA activity scores

    At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op

  • KOOS Jr Survey

    At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op

  • VR-12 Survey

    At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op

  • +3 more secondary outcomes

Study Arms (2)

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.

Behavioral: Hypnosis

Usual care

NO INTERVENTION

These patients will be enrolled in the study and usual care will be provided.

Interventions

HypnosisBEHAVIORAL

Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.

Hypnosis Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University/Stanford Healthcare

Palo Alto, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 35715013DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The treating team including surgeons, anesthesiologists, pain consultants, hospitalists who are in charge of administering pain medication and documenting outcomes will be blinded to the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor of Medicine

Study Record Dates

First Submitted

June 23, 2017

First Posted

October 12, 2017

Study Start

September 20, 2017

Primary Completion

August 30, 2019

Study Completion

August 30, 2020

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)