Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

NCT ID: NCT04765007

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2021-10-07

Brief Summary

Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help patients to accept their problem and to cope it. In consequence, the present study is aimed to evaluate the efficacy of a mindfulness therapy program in management of chronic orofacial pain.

Conditions

Mindfulness; Chronic Pain; Orofacial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness group

This arm will be treated with a mindfulness-based stress reduction therapy.

Group Type: EXPERIMENTAL

mindfulness-based stress reduction

Intervention Type: OTHER

Eight sessions of two hours and a half, one day per week during eight weeks. In addition, patients will perform a day of intensive silent practice of 6-8 hours of duration.

The content of each session balances three activities: the presentation of a topic, moments of dialogue and group exploration (using appreciative inquiry) and a Mindfulness practice.

The sessions will take place in online format, through the google meet application

Control group

This arm will be treated with a minimal intervention.

Group Type: OTHER

Minimal intervention

Intervention Type: OTHER

A guided meditation program of eight weeks of duration will be provided to the patients and they will be informed about the procedure and the beneficial effects of the therapy.

Interventions

mindfulness-based stress reduction

Eight sessions of two hours and a half, one day per week during eight weeks. In addition, patients will perform a day of intensive silent practice of 6-8 hours of duration.

The content of each session balances three activities: the presentation of a topic, moments of dialogue and group exploration (using appreciative inquiry) and a Mindfulness practice.

The sessions will take place in online format, through the google meet application

Intervention Type: OTHER

Minimal intervention

A guided meditation program of eight weeks of duration will be provided to the patients and they will be informed about the procedure and the beneficial effects of the therapy.

Intervention Type: OTHER

Other Intervention Names

MBSR

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria

• Pain with oncologic origin
• Severe mental disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Daniel Rodríguez Almagro

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yolanda Castellote

Role: CONTACT

mycastel@ujaen.es

+34953213519

Other Identifiers

mindfulness Ujaen

Identifier Type: -

Identifier Source: org_study_id