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Hypnosis, Chronic Pain ManagementNCT06279650

Self-hypnosis Training for Chronic Pain Management

A study testing Self-hypnosis and Psycho-education and cognitive Bahavioral therapy (CBT) in people with Hypnosis, Chronic Pain Management, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypnosis, Chronic Pain Management
What is being tested?
Self-hypnosis and Psycho-education and cognitive Bahavioral therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
1 Feb 2024to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria were to have participated in the past year in the self-hypnosis training program and to agree to take part in these research interviews.
  • be 18 years of age or older;
  • have received one of the above diagnoses, confirmed by medical record review or physician confirmation;
  • report pain that has been present for at least 3 months;
  • have a pain intensity over the last 24 hours (24h pain) of at least 4 on a Numerical Rating Scale (NRS) from 0 to 10 at baseline;
  • be able to read, speak and understand French;
  • have Internet access and be able to participate in a telepractice intervention group and complete online questionnaires.

Who cannot join

  • have deafness and/or severe cognitive impairment that may impair communication;
  • have current or recent psychiatric instability (e.g., active suicidal ideation, active delusional or psychotic thoughts) that could interfere with participation, as assessed by a clinical psychologist.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • 5415 Bd de l'Assomption

    Montreal, Quebec, H1T 2M4

    David Ogez, david.ogez@umontreal.ca

    Recruiting

Other trials in Canada

About this study

Official title: Self-hypnosis Training in Chronic Pain Management: A Qualitative Exploratory Study of Patients Practicing Self-hypnosis

Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.

The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.

Adverse events: none expected.

Read the detailed description

A self-hypnosis training program has been developed based on the experience of the program developed in medical oncology (phase I). The aim of this project is to analyze the self-hypnosis practice of chronic pain patients, and to evaluate the training program provided in pain management clinics, by means of qualitative research interviews. It is therefore situated at level Ib of the ORBIT model: Program refinement. Through this study, the investigators also wish to evaluate the effects of the intervention on users. In this context, the investigators hypothesize that patients who practice self-hypnosis show an improvement in their quality of life and a reduction in anxiety and pain levels. At this level, there are two objectives :

  1. To assess the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T3 (3-month follow-up).
  2. To assess the effects of hypnosis intervention on (i) change in 24h pain between T0 and T4 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.

Methods

Intervention : Self-hypnosis training Based on the exercises from the oncology pilot project, the investigators redefined a program applicable to the pain clinic (phase I ORBIT). To do so, the investigators maintained the stress and pain management exercises and removed the exercises relating to the management of secondary symptoms of cancer treatment. This new self-hypnosis training program is based on four complementary exercises: two on stress management and two on pain perception. Each exercise is organized according to the same hypnotic framework: induction, deepening, hypnotic work, post-hypnotic suggestions and return to the waking state. Each exercise is derived from the oncology study and has been enhanced by protocols drawn from the experience of other hypnotherapists.

The first exercise involves letting go of the emotions and stress associated with the painful condition, using the rucksack technique: a metaphor enabling the patient to empty an imaginary bag that is heavy and preventing him or her from moving forward. The weight of the bag represents the negative emotions, losses and pain that weigh down the patient's daily life. The second exercise focuses on the notion of acceptance, in the same way as cognitive-behavioral acceptance therapies. Suggestions and metaphors used in the work include the ideas of doing nothing, letting oneself be carried away and meditating in a pleasant place. The third exercise uses visualization techniques to modify pain. The modification concerns the form and intensity of the pain. Finally, the fourth exercise is derived from Rossi's protocol, which proposes mobilizing the patient's resources through levitation and catalepsy techniques. This technique focuses on the body and aims to restore confidence in the body in people with pain.

Participants: Sixty participants from pain clinic of our institution will be included in these research. They will be randomized in the two group of our study : hypnosis Vs Psychoeducation/CBT.

Procedures: Five measurement times will be used: T1-Start of research project; T2 - Mi-intervention, T3 - End of intervention, T4 - 3 months follow up, T5 - 6 months follow up. At each of these times, participants will complete self-administered questionnaires (pain, anxiety-depression and quality of life). The investigators will also collect a self-hypnosis practice diary, which the patient will complete during the course of the study: each week, the patient will note each practice in his or her diary, indicating the time and duration of the practice.

Measures: 24 h pain will be measured using the NRS from 0 to 10 (0 = no pain, 10 = the most horrible pain participants can imagine). The functional impact of pain will be measured using the Brief Pain Inventory (BPI). This 9-item scale assesses (1) the presence of pain, (2) the location of the pain, (3) the most intense pain, (4) the least intense pain, (5) the pain felt in general, (6) the pain felt at the moment on a NRS of 0 to 10. It also documents (7) the treatments used and (8) the relief provided over the last 24 hours. Item (9) concerns a subscale that documents the extent to which pain has interfered with 7 different activity and response domains (e.g., general activity, mood, relationships with others) over the last 24 hours, using an NRS from 0 to 10 (0 = pain does not interfere with this activity, 10 = pain interferes completely).

Anxiety-depression will be assessed using the Hospital anxiety and depression scale (HADS). This scale was developed for general practice patients and comprises 2 subscales of 7 items each, measuring anxiety and depression respectively. Each item is scored between 0 and 3. The score of each subscale is obtained by summing the scores of the 7 items, with a total score thus ranging from 0 to 21. The scale has been translated and validated in French.

Quality of life will be assessed by the SF-36 (36-Item Short Form Survey), which comprises 36 questions covering eight health domains: (1) Limitations in physical activities due to health problems; (2) Limitations in social activities due to physical or emotional problems; (3) Limitations in usual activities due to physical health problems; (4) Body pain; (5) General mental health (psychological distress and well-being); (6) Limitations in usual activities due to emotional problems; (7) Vitality (energy and fatigue); (8) General perception of health. The scores for the various domains are converted and pooled using a scoring key, to obtain a total score indicating a range of quality of life from low to high. Two component scores can also be tallied: a summary of the physical component and a summary of the mental component. Secondary measures concern hypnosis practice. The level of practice will be collected from the logbook. Participants will also be asked to self-assess their perceived levels of relaxation using a VAS-10 scale (0 = "not at all relaxed"; 10 = "very relaxed") before and after practice.

Analyses: Primary and secondary outcome measures will be compared across the three time points using repeated measures ANOVAs, and effect sizes will be calculated to document changes associated with the intervention. The investigators will also conduct correlations between self-hypnosis practice and scores on the measures taken. The investigators expect to see relationships between significant levels of practice and improvements in quality of life, and reductions in anxiety and pain levels.

Being tested
Self-hypnosis, Psycho-education and cognitive Bahavioral therapy (CBT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-hypnosisOther

    The HYlaDo intervention comprises 8 90-minute sessions. Session 1 offers psycho-education on pain and medical hypnosis. Sessions 2 to 7 offer brief introductions followed by hypnosis induction, during which the CBT elements (exposure and cognitive restructuring) to be worked on during the session are introduced. The sessions are aimed at managing: 2- anxiety and mood; 3- pain dramatization; 4- and 5- pain perception; 6- kinesiophobia; 7- future projection and resource mobilization. Session 8 provides feedback and recommendations for independent practice. Each hypnosis follows the same pattern: induction, deepening, CBT-based hypnotic work, post-hypnotic suggestions and return to wakefulness, explanations of the exercise and recommendations for independent practice.

  • Psycho-education and cognitive Bahavioral therapy (CBT)Other

    The psychoeducation-CBT intervention for pain and anxiety/depression consists of 8 90-minute sessions. It has already been implemented in HMR's pain clinic, and controls both the effects of time and repetition of measures, as well as non-specific factors including expectations associated with receiving active treatment, therapeutic relationship, frequency of encounters, and participation in a manualized intervention. It is designed to inform participants about pain, its costs, neurophysiology, nature and impact. It includes general information on pain, as well as information tailored to the participants' particular type of pain. The sessions are interactive, with the therapist stimulating discussion of the educational content and its relevance to the participants' lives.

Study groups in NCT06279650
Study groupRoleWhat they receive
Self-hypnosisExperimentalNot described
Receives: Other: Self-hypnosis
Psyco-education and cognitive behavioral therapyActive comparatorNot described
Receives: Other: Psycho-education and cognitive Bahavioral therapy (CBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time 1 : Numerical Rating Scale (NRS) from 0 to 10

    24 h pain will be measured using the NRS from 0 to 10 (0 = no pain, 10 = the most horrible pain participants can imagine)

    Measured: First day

  2. Time 1 : Questionnaire Brief Pain Inventory (BPI)

    The functional impact of pain will be measured using the Brief Pain Inventory (BPI) with 9-item scale assesses.

    Measured: First day

  3. Time 1 : Hospital anxiety and depression scale (HADS)

    Anxiety-depression will be assessed using the Hospital anxiety and depression scale (HADS).

    Measured: First day

  4. Time 1 : SF-36 (36-Item Short Form Survey)

    Quality of life will be assessed by the SF-36 (36-Item Short Form Survey), which comprises 36 questions covering eight health domains.

    Measured: First day

  5. Time 1 : Questionnaire socio-demographic and clinical

    A socio-demographic and clinical questionnaire will also be requested.

    Measured: First day

Secondary outcomes (4)
  1. Time 2 : Numerical Rating Scale (NRS) from 0 to 10

    24 h pain will be measured using the NRS from 0 to 10 (0 = no pain, 10 = the most horrible pain participants can imagine).

    Measured: 1 month

  2. Time 2 : Questionnaire Brief Pain Inventory (BPI)

    The functional impact of pain will be measured using the Brief Pain Inventory (BPI) with 9-item scale assesses.

    Measured: 1 month

  3. Time 2 : Hospital anxiety and depression scale (HADS)

    Anxiety-depression will be assessed using the Hospital anxiety and depression scale (HADS).

    Measured: 1 month

  4. Time 2 : SF-36 (36-Item Short Form Survey)

    Quality of life will be assessed by the SF-36 (36-Item Short Form Survey), which comprises 36 questions covering eight health domains.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279650
Sponsor's protocol ID
2022-2741
Status last verified
Jan 2025
First submitted
1 Feb 2024
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Self-hypnosis and Psycho-education and cognitive Bahavioral therapy (CBT) in people with Hypnosis, Chronic Pain Management, run by Ciusss de L'Est de l'Île de Montréal 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Ogez (514 609-4391, david.ogez@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time 1 : Numerical Rating Scale (NRS) from 0 to 10 (time frame: First day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Jan 2025.

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