20 Participants Needed

Face-Forward-Web for Orofacial Pain

JG
NL
Overseen ByNadine Levey, BA
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

You may need to stop taking certain medications. If you are on psychotropic medication, you must either stop taking it 2 weeks before joining the study or have been on a stable dose for at least 6 weeks.

What data supports the effectiveness of the treatment Face-Forward-Web for orofacial pain?

The 'About Face' program, which uses psychology and physiotherapy to help people with persistent facial pain, aims to improve their quality of life, suggesting that similar approaches like Face-Forward-Web could be effective.12345

How is the Face-Forward-Web treatment different from other treatments for orofacial pain?

Face-Forward-Web is unique because it combines psychological and physiotherapy techniques to manage persistent facial pain, focusing on skill development to improve quality of life, unlike traditional treatments that may focus solely on medication or physical therapy.15678

Eligibility Criteria

This trial is for adults with chronic orofacial pain, which includes persistent facial pain. The study aims to include up to 20 participants who are interested in trying a web-based mind-body intervention program called Face-Forward-Web.

Inclusion Criteria

Owns (or has easy access to) a device with internet access
English fluency and literacy
Ability and willingness to participate in the Face-Forward web-platform intervention
See 3 more

Exclusion Criteria

Pregnancy
I have practiced mindfulness for over 45 minutes weekly in the last 3 months.
Severe untreated mental health disorder (e.g., psychosis)
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Face-Forward-Web program, consisting of 5 on-demand sessions over a web platform, each approximately 30 minutes long, teaching relaxation, mindfulness, and cognitive-behavioral skills.

5 weeks
5 sessions (web-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a one-time exit interview to gather feedback on the program.

12 weeks
1 exit interview (15-30 minutes)

Treatment Details

Interventions

  • Face-Forward-Web
Trial Overview The Face-Forward-Web program, a web-based mind-body intervention designed for individuals suffering from chronic orofacial pain, is being tested for its feasibility, acceptability, and credibility through an open pilot study followed by exit interviews.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Face-Forward-WebExperimental Treatment1 Intervention
A 5-session web-based mind-body pain management intervention focused on decreasing pain and disability (physical and emotional) among adult patients with chronic orofacial pain.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials
312
Recruited
853,000+

References

Evaluation of About Face: A Psychology and Physiotherapy Pain Management Program for Adults with Persistent Facial Pain. [2023]
Developing Effective and Efficient care pathways in chronic Pain: DEEP study protocol. [2022]
DEEP Study: Utility of the multidimensional pain inventory in persistent oro-facial pain. [2021]
Development of an interdisciplinary specialist facial pain management programme. [2023]
Sleep disorders. Overview and relationship to orofacial pain. [2015]
Orofacial pain: a primer. [2022]
Pain Assessment in Oral Medicine through Its Different Dimensions: A Comprehensive Review. [2023]
Reviewing the evidence: can cognitive behavioral therapy improve outcomes for patients with chronic orofacial pain? [2021]
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