Self-hypnosis Training for Chronic Pain Management

NCT06279650 | Recruiting

• 1 other identifier: 2022-2741
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hypnosis, Chronic Pain Management

Outcome Measures

Primary Outcomes (5)

• 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)

  First day

• 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.

  First day

• Time 1 : Hospital anxiety and depression scale (HADS)

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

  First day

• 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.

  First day

• Time 1 : Questionnaire socio-demographic and clinical

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

  First day

Secondary Outcomes (4)

• Time 2 : Numerical Rating Scale (NRS) from 0 to 10

  1 month

• Time 2 : Questionnaire Brief Pain Inventory (BPI)

  1 month

• Time 2 : Hospital anxiety and depression scale (HADS)

  1 month

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

  1 month

Other Outcomes (12)

• Time 3 : Numerical Rating Scale (NRS) from 0 to 10

  2 months

• Time 3 : Questionnaire Brief Pain Inventory (BPI)

  2 months

• Time 3 : Hospital anxiety and depression scale (HADS)

  2 months

Study Arms (2)

Self-hypnosis

EXPERIMENTAL

Other: Self-hypnosis

Psyco-education and cognitive behavioral therapy

ACTIVE COMPARATOR

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

Interventions

Self-hypnosis OTHER

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.

Self-hypnosis

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.

Psyco-education and cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

5415 Bd de l'Assomption

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

David Ogez

CONTACT

514 609-4391; david.ogez@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Anesthesiology and Pain Medicine, Université de Montréal

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 28, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CA (1)