Development and Refinement of HYlaMI, a Self-Hypnosis Training Program for Migraine Management: An ORBIT Phase Ia-Ib...

Background/Objectives: Migraine is a prevalent and disabling neurological condition for which complementary non-pharmacological interventions remain underexplored. Hypnosis and self-hypnosis show promising potential for pain management; yet, structured, migraine-specific training programs remain limited. Following the ORBIT model, this Phase Ia-Ib study aimed to (1) define the HYlaMI program; (2) refine it through interviews with patients who received a detailed presentation of the program and experienced a single introductory hypnosis exercise drawn from it, without receiving the intervention itself, assessing perceived acceptability, benefits, limitations, and potential improvements; and (3) examine the within-session effects of that exercise on self-reported relaxation, anxiety, and pain, as well as on physiological activity. Methods: In this exploratory mixed-methods study, 17 adults living with migraines participated in a single-session study between September and December 2025. Participants were not exposed to the HYlaMI intervention at any point; they attended a single research session in which they received detailed information about the program and completed one hypnosis exercise drawn from it. Qualitative data were collected through semi-structured interviews, while quantitative measures included self-reported relaxation, anxiety and pain (rated verbally with the interviewer, who also delivered the exercise), and physiological activity (e.g., respiration and heart rate), assessed before, during and following the hypnosis exercise. Results: Four themes emerged: (1) Knowledge and impressions regarding hypnosis; (2) Relevance and acceptability of the program; (3) Expected and perceived effects of the program; and (4) Unanticipated elements. The fourth theme covers elements raised spontaneously by participants, notably migraine-related stigma and the ambivalence of relaxation. Participants showed strong enthusiasm for both hypnosis and the HYlaMI program. The hypnosis exercise was followed by significant improvements on numeric rating scales (0 to 10) for relaxation (M = 5.66 to 8.80), anxiety (3.28 to 0.88) and pain (2.81 to 1.31), all p ≤ 0.004 with large effect sizes (r = 0.67-0.88), alongside significant non-linear changes in heart rate, breathing rate and nociception. Conclusions: Findings support the acceptability of structured training programs based on hypnosis for migraine management and provide preliminary evidence of within-session benefits. They justify progression to ORBIT Phase II proof-of-concept and pilot studies testing the feasibility and preliminary efficacy of HYlaMI, and yield recommendations transferable to other non-pharmacological interventions for migraine.