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

8. Juni 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Experimental: 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).
Verhalten: 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.
Andere Namen:
  • Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Migraine-related disability - Migraine Disability Assessment (MIDAS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anxiety and depressive symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

12. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CEMTL 2026 4353

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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