- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03730350
Perioperative ACT-Based Clinical Hypnosis for Opioid Weaning
A Randomized-Controlled Trial of a Novel Perioperative Acceptance and Commitment Therapy and Clinical Hypnosis Program for Postsurgical Pain and Opioid Weaning
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Use: Measured as the morphine equivalent dosage (MED) and based on conversion methods used by doctors and nurses at the University Health Network
Time Frame: One Week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Surgical Pain Intensity: Measured using the numeric rating scale (0 = no pain; 10 = most pain imaginable)
Time Frame: One Week
|
Post-surgical pain intensity will be tested with a linear mixed effects model (group x time).
|
One Week
|
Post-Surgical Pain Interference: Measured using the Brief Pain Inventory
Time Frame: One Week
|
Pain interference will be tested with a linear mixed effects model (group x time). Pain interference has seven subscales of general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each subscale has five likert-type response options (not at all; extremely). Pain interference will be measured as the mean ratings of the seven subscales. |
One Week
|
Sleep Impairment; Measured using the Patient Report Outcomes Measurement Information System (PROMIS) - Sleep Disturbance and Sleep-Related Impairment
Time Frame: One Week
|
Sleep impairment will be tested with a linear mixed effects model (group x time). The majority of the PROMIS items employ response scales with five options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, 5 = Very much.Scores are calculated from the total of item responses, with higher scores reflecting greater sleep disturbance/impairment |
One Week
|
Mood: Measured using the Center for Epidemiological Studies Depression Scale Short-Form
Time Frame: One Week
|
Mood symptoms will be tested with a linear mixed effect models (group x time). The total score is calculated by the sum of the items with higher scores reflecting greater depressive symptomatology. |
One Week
|
Anxiety: Measured using the Generalized Anxiety Disorder Assessment
Time Frame: One Week
|
Anxiety symptoms will be tested with a linear mixed effect models (group x time). This 7-item scale assesses signs of GAD (e.g. "Feeling afraid as if something awful might happen") with response options of: (1) Not at all, (2) Several days, (3) More than half the days, (4) Nearly every day. Scores are calculated from the total of item responses, with higher scores reflecting greater anxiety. |
One Week
|
Parasympathetic Tone and Activation: Assessed by metrics of heart-rate variability (HRV)
Time Frame: One Month
|
Parasympathetic tone and activation will be measured during conditions of resting (5 minutes) and audio-guided relaxation (10 minutes).
Higher HRV values reflect greater parasympathetic tone and activation.
The effects of the intervention on parasympathetic tone and activation will be tested with a linear mixed effects model with group (hypnosis, standard care) and time (pre-surgery, one month post-surgery) as between-group factors, condition (rest, relaxation) as the within-subject factor, and heart-rate variability as the dependent variable.
|
One Month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hance Clarke, MD, PhD, Toronto General Hospital
Publications and helpful links
General Publications
- 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.
- 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
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-5441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Surgical Pain
-
McMaster UniversitySt. Joseph's Healthcare HamiltonCompleted
-
PfizerTerminated
-
Stanford UniversityCompletedPost Surgical PainUnited States
-
University of Alabama at BirminghamTerminatedPost Surgical PainUnited States
-
University of Colorado, DenverNational Cancer Institute (NCI)RecruitingCancer | Cannabis Use | Post-Surgical Pain | Post-Surgical ComplicationUnited States
-
University of PennsylvaniaCompletedPost Surgical PainUnited States
-
East and North Hertfordshire NHS TrustNational Institute for Health Research, United Kingdom; Manuka Doctor UK LtdRecruitingAnalgesia | Post Surgical PainUnited Kingdom
-
Children's Hospital Medical Center, CincinnatiThe Society for Pediatric AnesthesiaActive, not recruiting
-
Defense and Veterans Center for Integrative Pain...Active, not recruiting
-
Laboratorios del Dr. Esteve, S.A.Premier Research Group plcCompletedAcute Post-surgical PainUnited States
Clinical Trials on Clinical Hypnosis
-
Vanderbilt University Medical CenterCompleted
-
Vanderbilt University Medical CenterCompleted
-
The University of QueenslandCompletedMindfulness Meditation | Clinical HypnosisAustralia
-
Johann Wolfgang Goethe University HospitalUnknown
-
University of LiegeOncomfort; BiowinNot yet recruiting
-
Instituto Docusse de Osteopatia e Terapia ManualUniversidade Estadual do Norte do ParanáCompleted
-
Johann Wolfgang Goethe University HospitalUnknown
-
University of Colorado, DenverCompletedAnxiety | Magnetic Resonance Imaging | ClaustrophobiaUnited States
-
University Hospital, BordeauxActive, not recruitingPain | Peripheral NeuropathyFrance
-
The University of QueenslandUniversity of Alabama, TuscaloosaNot yet recruiting