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

2026年6月8日 更新者：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).

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • カナダ
    • Quebec
      • Montreal、Quebec、カナダ、H1T 2M4
        • Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：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.
実験的：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).
行動：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.
他の名前：
  • Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Migraine-related disability - Migraine Disability Assessment (MIDAS)
時間枠：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)
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Anxiety and depressive symptoms
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ciusss de L'Est de l'Île de Montréal

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年9月30日

試験登録日

最初に提出

2026年5月12日

QC基準を満たした最初の提出物

2026年6月8日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月12日

QC基準を満たした最後の更新が送信されました

2026年6月8日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CEMTL 2026 4353

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いいえ

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