← Back to all trials
Completed
NCT06754917
Feasibility Testing of the "Face-Forward-Web" Program for Chronic Orofacial Pain
Conditions: Orofacial Pain, Facial Pain
Sex: All
Ages: 18 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
The goal of this study is to conduct a feasibility open pilot study (N=Up to 20) with exit interviews to assess the feasibility, acceptability, and credibility of the study protocol and Face-Forward-Web; a web-based mind-body intervention for adult patients with COP.
Deliverables: \[1\] Adapt and refine open pilot protocol, patient recruitment, and other study materials. \[2\] Assess the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention methodology in preparation for a future efficacy study.
This research leverages mixed methods information to evaluate the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention and study methodology in preparation for the subsequent pilot study and again later, for a pilot feasibility randomized control trial (RCT).
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18
2. English fluency and literacy
3. Nonmalignant chronic (\>3 months) orofacial pain
4. Ability and willingness to participate in the Face-Forward web-platform intervention
5. Free of concurrent psychotropic medication 2 week prior to participation OR stable psychotropic medication dose and type for ≥ 6 weeks
6. Pain score ≥4/10 on the Numerical Rating Scale
7. Owns (or has easy access to) a device with internet access
Exclusion Criteria:
1. Practice of mindfulness \> 45 minutes/week in the past 3 months
2. Participation in mind-body or cognitive-behavioral therapy in the past 3 months
3. Severe untreated mental health disorder (e.g., psychosis)
4. Active suicidal ideation with plan or intent
5. Pregnancy
Source: ClinicalTrials.gov (NCT06754917). StuddyBuddy aggregates publicly available trial information.