Perioperative ACT-Based Clinical Hypnosis for Opioid Weaning
Condition: Post-Surgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

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.
    

Intervention name(s): Clinical Hypnosis
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: None (Open Label)
Primary purpose: Treatment