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Perioperative ACT-Based Clinical Hypnosis for Opioid Weaning

NCT ID: NCT03730350

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2020-05-30

Brief Summary

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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.

Detailed Description

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Hypnosis is one of the oldest strategies for the management of pain; however, interest in hypnosis as a pain management strategy has ebbed and flowed over time. Given the current concern over opioid use for pain management, non-pharmacological pain management options, such as clinical hypnosis, are being revisited. In addition, over the past twenty years, there has been a new wave of scientific investigation into the efficacy of hypnosis for acute and chronic pain. As a result of this body of evidence for the efficacy of clinical hypnosis for pain management, the American Psychological Association has recommended that clinical hypnosis be included as part of standard care for pain relief, unless an individual indicates a strong aversion to it.

Previous research has investigated the utility of clinical hypnosis for pain management in the perioperative context. Surgical patients who received adjunct hypnosis treatment had better outcomes (e.g., less pain, better mood, and less medication use) than 89% of patients who received treatment as usual, as evidenced by large effect sizes across 1624 patients from randomized and non-randomized controlled trials. A more recent meta-analysis demonstrated small to medium effects in favor of hypnosis on various post-surgical outcomes (e.g., pain, emotional distress, medication consumption, and post-surgical recovery), across 2597 patients in randomized controlled trials. Although these meta-analyses have demonstrated an association between the implementation of hypnosis interventions and an overall reduction in medication consumption, previous investigations have rarely focused specifically on reduced use of opioid medication, which is important in the context of current concerns about opioid overuse.

Furthermore, meta-analyses have indicated that dysregulation of the parasympathetic nervous system is associated with the development of chronic pain, leaving sufferers unable to regulate stress, recovery, and relaxation processes. The investigators hypothesize that the relaxation associated with the clinical hypnosis intervention will lead to activation of the parasympathetic nervous system and, accordingly, greater heart rate variability. Therefore, the investigators hypothesize that patients who are randomized to the clinical hypnosis treatment will not only use less opioid medication in the week after surgery, but will also demonstrate greater heart rate variability at one month post-surgery, which is thought to protect against the development of long-term pain.

The study's goal is to provide patients with a range of strategies that will be most helpful and efficacious in reducing suffering during the pre- and post-operative periods. A secondary goal is to deliver as much therapeutic content as possible through audio recordings in order to create a psychological intervention that requires less face-to-face contact between clinician and patient, but provides more support (e.g., patients can listen to the recordings at bedtime when the clinician would not be available on a daily basis). The use of audio recordings will conserve staffing resources, while at the same time allowing for the dissemination of pain psychology tools to more patients. Therefore, in the current study, the study aims to test the feasibility and efficacy of this approach, termed ACT-Informed Clinical Hypnosis.

Conditions

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Post-Surgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Hypnosis

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.

Group Type EXPERIMENTAL

Clinical Hypnosis

Intervention Type 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.

Standard Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clinical Hypnosis

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Jo Carroll

Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hance Clarke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 19596518 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 26752494 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38524266 (View on PubMed)

Other Identifiers

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17-5441

Identifier Type: -

Identifier Source: org_study_id