Perioperative ACT-Based Clinical Hypnosis for Opioid Weaning

Post-Surgical Pain Clinical Trial

Official title:

A Randomized-Controlled Trial of a Novel Perioperative Acceptance and Commitment Therapy and Clinical Hypnosis Program for Postsurgical Pain and Opioid Weaning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730350
• Other study ID #: 17-5441
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: December 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 30, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Surgical Pain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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

Jensen MP. Hypnosis for chronic pain management: a new hope. Pain. 2009 Dec;146(3):235-7. doi: 10.1016/j.pain.2009.06.027. Epub 2009 Jul 10. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-Surgical Pain Intensity: Measured using the numeric rating scale (0 = no pain; 10 = most pain imaginable)	Post-surgical pain intensity will be tested with a linear mixed effects model (group x time).	One Week
Secondary	Post-Surgical Pain Interference: Measured using the Brief Pain Inventory	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
Secondary	Sleep Impairment; Measured using the Patient Report Outcomes Measurement Information System (PROMIS) - Sleep Disturbance and Sleep-Related Impairment	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
Secondary	Mood: Measured using the Center for Epidemiological Studies Depression Scale Short-Form	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
Secondary	Anxiety: Measured using the Generalized Anxiety Disorder Assessment	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
Secondary	Parasympathetic Tone and Activation: Assessed by metrics of heart-rate variability (HRV)	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