Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Not Applicable

• Conditions: Chronic Pain; Mindfulness; Orofacial Pain
• Interventions: Other: mindfulness-based stress reduction; Other: Minimal intervention

• Registration Number: NCT04765007
• Lead Sponsor: University of Jaén

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03
• Study Start: 2021-05-04
• Primary Completion: 2021-05-04
• Study Completion: 2021-10-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria

• Pain with oncologic origin
• Severe mental disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness group	mindfulness-based stress reduction	This arm will be treated with a mindfulness-based stress reduction therapy.
Control group	Minimal intervention	This arm will be treated with a minimal intervention.

Primary Outcome Measures

Name	Time	Method
orofacial pain intensity	5 months	mean of orofacial pain in the last seven daysevaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
Symptoms of temporomandibular disorders	5 months	Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Dizziness-related disability	5 months	Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Catastrophization of pain	5 months	Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Kinesiophobia	5 months	Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Sleep quality	5 months	Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Neck pain-related disability	5 months	Assessment of neck pain-related disability with Neck Disability Index (NDI)
Impact of headache	5 months	Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)