Recruiting

Self-Hypnosis

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT06279650

Conditions

Hypnosis, Chronic Pain Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Self-hypnosis

Psycho-education and cognitive Bahavioral therapy (CBT)

Study Details

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

Study ID

NCT06279650

Start date

Feb 1, 2024

Status verified date

Jan, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Self-hypnosis

active comparator: Psyco-education and cognitive behavioral therapy

Interventions

Self-hypnosis

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)

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.

Primary outcome measure

  • Time 1 : Numerical Rating Scale (NRS) from 0 to 10 [ Time Frame: First day ]
  • Time 1 : Questionnaire Brief Pain Inventory (BPI) [ Time Frame: First day ]
  • Time 1 : Hospital anxiety and depression scale (HADS) [ Time Frame: First day ]
  • Time 1 : SF-36 (36-Item Short Form Survey) [ Time Frame: First day ]
  • Time 1 : Questionnaire socio-demographic and clinical [ Time Frame: First day ]

Central Contacts and Locations

Central contacts

David Ogez

514 609-4391david.ogez@umontreal.ca

Locations

5415 Bd de l'Assomption

Recruiting

Montréal, Quebec, Canada, H1T 2M4

Contacts

David Ogez

david.ogez@umontreal.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Jan 28, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2025-01-28.