Post-Surgical PainNCT03730350
Perioperative ACT-Based Clinical Hypnosis for Opioid Weaning
A study testing Clinical Hypnosis in people with Post-Surgical Pain, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-Surgical Pain
- What is being tested?
- Clinical Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80
- Scheduled for surgical oncology procedure (i.e., thoracic, gastrointestinal, gynecologic oncology, urologic, head and neck or breast cancer surgery)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized-Controlled Trial of a Novel Perioperative Acceptance and Commitment Therapy and Clinical Hypnosis Program for Postsurgical Pain and Opioid Weaning
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.
Read the 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.
- Conditions
- Post-Surgical Pain
- Being tested
- Clinical Hypnosis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical HypnosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Week
Secondary outcomes (6)
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).
Measured: One Week
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.
Measured: One Week
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
Measured: One Week
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.
Measured: One Week
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.
Measured: One Week
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.
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start15 Nov 2018
- Primary completion10 Dec 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-Surgical PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Carroll, University Health Network, Toronto
- Investigators
- Hance Clarke, MD, PhD, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730350
- Sponsor's protocol ID
- 17-5441
- Status last verified
- Dec 2020
- First submitted
- 30 Oct 2018
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19596518American 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.
PubMed 26752494Azam 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.
PubMed 38524266
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Controlled Trial of a Novel Perioperative Acceptance and Commitment Therapy and Clinical Hypnosis Program for Postsurgical Pain and Opioid Weaning
- ClinicalTrials.gov ID
- NCT03730350
- Acronym / sponsor ID
- 17-5441
- Conditions
- Post-Surgical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Behavioral: Clinical HypnosisPrior 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-80
- Scheduled for surgical oncology procedure (i.e., thoracic, gastrointestinal, gynecologic oncology, urologic, head and neck or breast cancer surgery)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical HypnosisHypnosis 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. | Behavioural | Hypnosis |
Primary outcome
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.
6 secondary outcomes
Post-Surgical Pain Intensity: Measured using the numeric rating scale (0 = no pain; 10 = most pain imaginable)
Time frame: One Week
Post-Surgical Pain Interference: Measured using the Brief Pain Inventory
Time frame: One Week
Sleep Impairment; Measured using the Patient Report Outcomes Measurement Information System (PROMIS) - Sleep Disturbance and Sleep-Related Impairment
Time frame: One Week
Mood: Measured using the Center for Epidemiological Studies Depression Scale Short-Form
Time frame: One Week
Anxiety: Measured using the Generalized Anxiety Disorder Assessment
Time frame: One Week
Parasympathetic Tone and Activation: Assessed by metrics of heart-rate variability (HRV)
Time frame: One Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Background: PubMed 19596518Jensen 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.
- BackgroundAmerican 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: PubMed 26752494Koenig 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.
- Derived from this study: PubMed 38524266Azam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hance Clarke, MD, PhD principal investigator
Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Hypnosis in people with Post-Surgical Pain, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730350, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.