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Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study (HYlaMI)

8 giugno 2026 aggiornato da: David Ogez, Ciusss de L'Est de l'Île de Montréal

Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study of the Intervention Program (ORBIT Phase IIa-IIb)

Migraine is one of the most common and disabling neurological conditions worldwide, affecting approximately 1 billion people. Available pharmacological treatments have significant limitations (side effects, contraindications, medication overuse), highlighting the need for effective non-pharmacological alternatives.

The HYlaMI program (Self-Hypnosis Training for Migraine Management) is an 8-session group-based telehealth intervention adapted from HYlaDO, a self-hypnosis program developed for chronic pain management at the Hôpital Maisonneuve-Rosemont Pain Clinic (Montréal, Canada). Building on a refinement study conducted in autumn 2025 (CER: 2026-4061), HYlaMI combines heterohypnosis (guided by a trained clinician) and self-hypnosis (practiced autonomously at home using audio recordings) through weekly one-hour video sessions (Zoom/CIUSSS EMTL platform).

This study combines ORBIT Phase IIa (proof of concept) and Phase IIb (pilot study) objectives. The primary aims are to evaluate the feasibility of the HYlaMI program (retention and adherence rates) and to assess whether it can generate a clinically significant change in migraine-related disability compared to a waitlist control group. Secondary aims include evaluating effects on anxiety and depressive symptoms, pain self-efficacy, situational pain/anxiety/relaxation, migraine frequency, intensity and duration, medication intake, work absenteeism, quality of life, and the economic burden of migraine.

A mixed-methods design will be used. Forty adults with a diagnosis of migraine for more than one year will be randomized to either the HYlaMI intervention group (n=20) or a waitlist control group (n=20). Participants will complete validated questionnaires at multiple time points (pre-intervention, mid-intervention, post-intervention, and 4-week follow-up), a weekly migraine diary, and self-hypnosis practice logs. Two semi-structured focus groups will be conducted with intervention group participants to inform program improvement.

If successful, this study will provide the evidence base required to proceed to a larger randomized controlled trial (ORBIT Phase III).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background.

Migraine affects approximately 1.04 billion individuals worldwide and is associated with substantial socioeconomic burdens, including reduced quality of life, mental health comorbidities (anxiety, depression), and productivity losses. Non-pharmacological interventions, including clinical hypnosis, represent a growing area of investigation.

Intervention.

The HYlaMI program consists of 8 weekly one-hour group sessions delivered via teleconference (Zoom, CIUSSS EMTL platform). Seven hypnotic exercises are introduced sequentially, each following a standard hypnotic structure (induction, deepening, hypnotic work, post-hypnotic suggestions, return to waking state):

  • Session 1: Psychoeducation on medical hypnosis and pain + "Pleasant place" exercise
  • Session 2: "Backpack" exercise (anxiety and emotion management)
  • Session 3: "Doing nothing" exercise (pain acceptance, catastrophizing)
  • Session 4: "Thermal object" exercise (pain perception modification)
  • Session 5: "Magic hand" exercise (analgesic suggestion)
  • Session 6: "Rossi method" (resource-based pain relief)
  • Session 7: "Reconnecting with a resource" (introspection and self-efficacy)
  • Session 8: Conclusion, self-hypnosis prescription and 30 minutes Focus group on Social Validity of the intervention

A 9th session (1h-Focus group on Self-hypnosis practice+ follow-up meeting) is held 4 weeks post-intervention.

All 7 hypnotic exercises are provided as high-quality audio recordings to enable home self-hypnosis practice between sessions.

Study Design

Mixed-methods pilot and proof-of-concept study with two parallel arms: HYlaMI intervention group and waitlist control group. Randomization is performed using an online random group generator. For ethical reasons, waitlist participants will receive the full intervention after study completion.

Outcome Assessment Schedule

14 measurement time points are planned: T-1 and T0 (pre-intervention baseline), T1-T8 (weekly during intervention), and T9-T12 (weekly post-intervention follow-up).

Hypnotizability

Baseline hypnotizability is assessed using the Harvard Group Scale of Hypnotic Susceptibility, Form A (HGSHS:A), French online version, and will be used as a covariate in all analyses.

Data Management

Electronic questionnaires are managed via REDCap (CIUSSS EMTL server). Paper journals are used for in-session measures. Focus groups are recorded via Zoom, transcribed using OneDrive Word, and analyzed with NVivo 12.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR)
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Formal diagnosis of migraine for more than one year (physician-issued; self-reported diagnosis accepted)
  • French-speaking
  • No consumption of alcohol or recreational drugs on the morning before group hypnosis sessions (migraine rescue medication is accepted but must be reported if taken before a session)
  • Reliable internet connection
  • Available to follow the 2.5-month self-hypnosis training program

Exclusion Criteria:

  • Sensory or cognitive impairments that would interfere with comprehension (e.g., deafness)
  • Severe, unstabilized neurological or psychiatric disorder that impairs communication
  • Previous psychological treatment using hypnosis techniques for pain management
  • Current participation in another psychological intervention (potential confounder for anxiety/depression outcomes)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Waitlist control group
Participants assigned to the waitlist control group do not receive the HYlaMI intervention during the study period. They complete the same electronic questionnaires and weekly migraine diaries as the intervention group. For ethical reasons, they will receive the full HYlaMI intervention after study completion.
Sperimentale: HYlaMI Intervention Group
Participants assigned to the HYlaMI group attend 8 weekly group telehealth sessions and practice self-hypnosis at home using provided audio recordings. They complete paper journals (in-session EVA ratings and qualitative feedback), weekly electronic migraine diaries, weekly self-hypnosis practice logs, and all standardized questionnaires at designated time points. They participate in two semi-structured focus groups (T8 and T12).
Comportamentale: HYlaMI (Self-Hypnosis Training for Migraine Management)
Eight weekly one-hour group telehealth sessions (Zoom/CIUSSS EMTL platform) delivering 7 complementary self-hypnosis exercises targeting migraine-related pain, stress, anxiety, and psychological resources. Each session follows a standardized hypnotic structure. High-quality audio recordings of all exercises are provided to participants for home self-hypnosis practice. A clinician-researcher (doctoral candidate in neuropsychology, trained in hypnosis) leads all sessions using a standardized clinician manual. A concluding focus group and follow-up session is held 4 weeks post-intervention.
Altri nomi:
  • Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Migraine-related disability - Migraine Disability Assessment (MIDAS)
Lasso di tempo: One-week-pre-intervention (T0) and 4-week post-intervention follow-up (4-weeks-post-intervention: T12)
5-item scale quantifying the number of days affected by migraine in the past 3 months, generating a disability grade (I-IV). Clinically significant improvement defined as a reduction of ≥5 points (grade III, initial score 11-20) or ≥30% (grade IV, initial score >20), per American Headache Society (2019) criteria.
One-week-pre-intervention (T0) and 4-week post-intervention follow-up (4-weeks-post-intervention: T12)
Migraine-related disability - Headache Impact Test (HIT-6)
Lasso di tempo: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
6-item scale (score range 36-78) assessing headache impact on daily functioning. Clinically significant improvement defined as a reduction of ≥5 points, per American Headache Society (2019) criteria.
One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
Program feasibility - Retention and adherence rates
Lasso di tempo: Throughout intervention (first to 8th week of intervention: T1-T8)
Descriptive analysis of session attendance (target: ≥6/8 sessions) and attrition rate (target: ≤15%), based on the HYlaDO pilot study.
Throughout intervention (first to 8th week of intervention: T1-T8)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety and depressive symptoms
Lasso di tempo: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
Hospital Anxiety and Depression Scale (HADS)
One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
Pain self-efficacy
Lasso di tempo: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
Pain Self-Efficacy Questionnaire (PSEQ)
One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
Situational pain
Lasso di tempo: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Visual Analog Scale (VAS), 0-10
Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Situational anxiety
Lasso di tempo: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Visual Analog Scale (VAS), 0-10
Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Situational relaxation
Lasso di tempo: Before and after each hypnosis session (First to 7th week of intervention: T1-T7)
Visual Analog Scale (VAS), 0-10
Before and after each hypnosis session (First to 7th week of intervention: T1-T7)
Migraine frequency
Lasso di tempo: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12 )
Weekly migraine diary (number of migraine days per week)
Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12 )
Measure: Migraine intensity
Lasso di tempo: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (average intensity, 0-10)
Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Migraine duration
Lasso di tempo: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (duration in minutes)
Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Medication intake
Lasso di tempo: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (type, dose, number of tablets)
Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Work/school absenteeism
Lasso di tempo: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (number of absent days)
Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Quality of life economics
Lasso di tempo: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
EQ-5D (5 dimensions + VAS, score 0-1 and 0-100)
One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)
Economic burden of migraine
Lasso di tempo: 6th week of intervention and 4-weeks-post-intervention follow-up (T6, T12)
Cost in health questionnaire (direct and indirect costs)
6th week of intervention and 4-weeks-post-intervention follow-up (T6, T12)
Program improvement
Lasso di tempo: T8 (end of intervention) and T12 (4-week follow-up)
Qualitative thematic analysis of two semi-structured focus groups
T8 (end of intervention) and T12 (4-week follow-up)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 settembre 2027

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

12 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CEMTL 2026 4353

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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