Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 27, 2025
Date Accepted: Jul 18, 2025
Development of a novel web-based intervention targeting pain-related outcomes in chronic orofacial pain: Protocol for a mixed methods study
ABSTRACT
Background:
Chronic orofacial pain (COP) is common, costly, and associated with substantial pain interference and emotional distress. Psychosocial treatments for COP are scarce and limited (e.g., relying on talking, which is often painful for this population; requiring intensive resources limiting scalability). Here, we describe the study protocol for developing Face-Forward-Web, a web-based, “talk-free” mind-body intervention for patients with COP. We aim to: 1) develop Face-Forward-Web with the aid of live-video focus groups with adults with COP; and 2) optimize Face-Forward-Web and our study protocol through beta testing followed by an open pilot feasibility trial.
Objective:
We aim to: 1) develop Face-Forward-Web with the aid of live-video focus groups with adults with COP; and 2) optimize Face-Forward-Web and our study protocol through beta testing followed by an open pilot feasibility trial.
Methods:
We will accomplish these aims with two phases, incorporating user-centered design principles. For Phase 1, we are conducting semi-structured focus groups (N=4-5 groups, 20 patients or until thematic saturation) with individuals with COP. We are using Rapid Data Analysis followed by thematic analysis to gauge treatment needs, preferences, and perceptions of the proposed platform and skills. This information will inform session structure and content, as well as development of a wireframe followed by a prototype. For Phase 2, we will conduct beta testing (up to n=10) followed by an open pilot (up to n=20) with exit interviews to gather feedback. Primary outcomes are feasibility such as recruitment (≥70% of eligible participants will participate), acceptability (≥70% of participants complete ≥ 4/5 sessions), credibility, expectancy (≥70% above the Credibility and Expectancy scale’s mid-point), and satisfaction (≥70% above the User Experience Questionnaire’s mid-point). We will also explore preliminary improvements in outcomes (pain interference, emotional distress) and mechanistic targets (pain catastrophizing, fear of pain, mindfulness).
Results:
The trial is ongoing.
Conclusions:
Face-forward-Web will be the first “talk-free” web-based intervention tailored for the needs of adults with COP. Results will inform a future efficacy trial.
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