Development of a Novel Web-Based Intervention Targeting Pain-Related Outcomes in Individuals With 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 (eg, rely on talking, which is often painful for this population; require intensive resources, limiting scalability). Here, we describe the study protocol for developing Face-Forward-Web, a “talk-free” web-based mind-body intervention for patients with COP. 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 feasibility trial. Methods We will accomplish these aims in 2 phases, incorporating user-centered design principles. For phase 1, we conducted semistructured focus groups (n=4 groups, 22 participants) 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 a feasibility trial (up to n=20) with exit interviews to gather feedback. The primary outcomes are feasibility benchmarks such as recruitment (≥70% of the eligible participants will participate), acceptability (≥70% of the participants complete ≥4 or 5 sessions), credibility, expectancy (≥70% above the Credibility and Expectancy scale’s midpoint), and satisfaction (≥70% above the User Experience Questionnaire’s midpoint). Results Recruitment for phase 1 began in October 2024 and concluded in January 2025. Data analysis for phase 1 will conclude in fall 2025 and for phase 2 in 2026. Results will iteratively guide the development of the intervention. Conclusions Face-Forward-Web will be the first talk-free web-based intervention tailored to the needs of adults with COP. Results will inform a future efficacy trial. Trial Registration ClinicalTrials.gov NCT06754917; https://clinicaltrials.gov/study/NCT06754917 International Registered Report Identifier (IRRID) DERR1-10.2196/71839