About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Self-hypnosis
Other interventionThe 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 interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
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.
Time 1 : Hospital anxiety and depression scale (HADS)
Anxiety-depression will be assessed using the Hospital anxiety and depression scale (HADS).
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.
Secondary outcomes
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).
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.
Time 2 : Hospital anxiety and depression scale (HADS)
Anxiety-depression will be assessed using the Hospital anxiety and depression scale (HADS).
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.
Other outcomes
Time 3 : 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).
Time 3 : Questionnaire Brief Pain Inventory (BPI)
The functional impact of pain will be measured using the Brief Pain Inventory (BPI) with 9-item scale assesses.
Time 3 : Hospital anxiety and depression scale (HADS)
Anxiety-depression will be assessed using the Hospital anxiety and depression scale (HADS). Quality of life will be assessed by the SF-36 (36-Item Short Form Survey), which comprises 36 questions covering eight health domains.
Time 3 : 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.
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