Perioperative ACT-Based Clinical Hypnosis for Opioid Weaning

NCT03730350 | Completed

• 1 other identifier: 17-5441
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized-controlled trial (RCT) will evaluate the effectiveness of a pain psychology intervention -- consisting of a hybrid of acceptance and commitment therapy (ACT) and clinical hypnosis intervention -- in reducing opioid consumption after major surgery. Consenting patients undergoing oncology surgeries at Toronto General Hospital (TGH) will be randomly assigned to one of two groups: (1) standard care or (2) standard care plus an ACT/clinical hypnosis intervention for pain management. The hypnosis intervention will be delivered via one session with a psychotherapist prior to surgery, one session with a psychotherapist after surgery, and the provision of audio recordings to guide patients in practicing self-hypnosis. The pain psychology intervention is targeted at reducing pain, as well as pain-related anxiety, distress, sleep disturbance, and functional impairment. The primary goal of the pain psychology intervention is to help patients to feel more comfortable while using less opioid medication in the week after surgery.

Conditions

Post-Surgical Pain

Outcome Measures

Primary Outcomes (1)

• Opioid Use: Measured as the morphine equivalent dosage (MED) and based on conversion methods used by doctors and nurses at the University Health Network

  The effectiveness of the intervention on opioid use will be tested using a 2 factor mixed effects linear model with group (hypnosis vs. standard care) and time (pre-surgery, one week post-surgery) as factors. The investigators predict significantly lower mean daily morphine-equivalent opioid use in the hypnosis group compared to standard care at one week post surgery. MED values typically range between 0-200 milligrams/day and higher values mean greater opioid use.

  One Week

Secondary Outcomes (6)

• Post-Surgical Pain Intensity: Measured using the numeric rating scale (0 = no pain; 10 = most pain imaginable)

  One Week

• Post-Surgical Pain Interference: Measured using the Brief Pain Inventory

  One Week

• Sleep Impairment; Measured using the Patient Report Outcomes Measurement Information System (PROMIS) - Sleep Disturbance and Sleep-Related Impairment

  One Week

• Mood: Measured using the Center for Epidemiological Studies Depression Scale Short-Form

  One Week

• Anxiety: Measured using the Generalized Anxiety Disorder Assessment

  One Week

Study Arms (2)

Hypnosis

EXPERIMENTAL

Prior to surgery, a member of the pain psychology team will guide patients through a clinical hypnosis session aimed at preparing for surgery by reducing anxiety and introducing relaxation and self-soothing strategies that can be used after surgery for adaptive coping. They will also be provided with a recording of this hypnosis script to use at home, and it will be recommended that they listen to the recording on the two days prior to surgery. Following surgery, a clinician from the pain psychology team will visit the patient in hospital on post-operative day one or whenever they are able to be seen prior to hospital discharge, in order to guide them through a clinical hypnosis session targeted at increasing comfort and pain relief.

Behavioral: Clinical Hypnosis

Standard Care

NO INTERVENTION

This control group will receive standard care pre- and post-surgery. After the completion of their one-month trial, control participants will be offered access to the hypnosis recordings, as well as an in-person hypnosis session.

Interventions

Clinical Hypnosis BEHAVIORAL

Hypnosis guidance and audio tracks aimed at promoting pain relief, reducing distress and anxiety, and facilitating sleep will be provided for independent use, with daily practice recommended. Each hypnosis session will be 20-25 minutes long. The scripts for these sessions have been developed based on the clinical literature (e.g., Elkins, 2014) and are already in use with patients of the pain service.

Hypnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-80
• Scheduled for surgical oncology procedure (i.e., thoracic, gastrointestinal, gynecologic oncology, urologic, head and neck or breast cancer surgery)

You may not qualify if:

• Patients with limited comprehension of English who would not be able to understand the verbal instructions for clinical hypnosis
• Patients with a known history of serious mental illness (e.g., schizophrenia and/or current PTSD)
• Patients with cognitive deficits due to dementia whose comprehension may limit benefit

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (4)

• Jensen MP. Hypnosis for chronic pain management: a new hope. Pain. 2009 Dec;146(3):235-237. doi: 10.1016/j.pain.2009.06.027. Epub 2009 Jul 10. No abstract available.

  PMID: 19596518 BACKGROUND

• American Psychological Association, D., Society of Psychological Hypnosis. (2004). Hypnosis for the Relief and Control of Pain. Retrieved from http://www.apa.org/research/action/hypnosis.aspx

  BACKGROUND

• Koenig J, Falvay D, Clamor A, Wagner J, Jarczok MN, Ellis RJ, Weber C, Thayer JF. Pneumogastric (Vagus) Nerve Activity Indexed by Heart Rate Variability in Chronic Pain Patients Compared to Healthy Controls: A Systematic Review and Meta-Analysis. Pain Physician. 2016 Jan;19(1):E55-78.

  PMID: 26752494 BACKGROUND

• Azam MA, Weinrib AZ, Slepian PM, Rosenbloom BN, Waisman A, Clarke H, Katz J. Effects of perioperative clinical hypnosis on heart rate variability in patients undergoing oncologic surgery: secondary outcomes of a randomized controlled trial. Front Pain Res (Lausanne). 2024 Mar 8;5:1354015. doi: 10.3389/fpain.2024.1354015. eCollection 2024.

  PMID: 38524266 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hance Clarke, MD, PhD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Random assignment to group will take place after baseline assessment. Patients who are randomly assigned to the clinical hypnosis group will immediately undergo their first in-person hypnosis session focused on preparing for surgery. Masking is not employed as patients will know if they are randomized to the intervention arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Model Details: This study will conduct a 2-arm (intervention vs. treatment-as-usual) pilot RCT with patients currently undergoing oncology surgery at Toronto General Hospital. This study will recruit N = 92 patients (n = 46 psychology intervention, n = 46 control). The psychology intervention will be delivered by the TPS pain psychology team, under the supervision of Transitional Pain Service lead pain psychologist Dr. Aliza Weinrib. In addition, audio recordings developed by Dr. Weinrib will be provided to patients

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 5, 2018
• Study Start: November 15, 2018
• Primary Completion: December 10, 2019
• Study Completion: May 30, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)