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Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04765007
Enrollment
40
Registered
2021-02-21
Start date
2021-05-04
Completion date
2021-10-07
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness, Chronic Pain, Orofacial Pain

Keywords

mindfulness, chronic pain, orofacial pain

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.

Interventions

OTHERmindfulness-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

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.

Sponsors

University of Jaén
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed of orofacial chronic pain by a physician.

Exclusion criteria

* Pain with oncologic origin * Severe mental disorder

Design outcomes

Primary

MeasureTime frameDescription
orofacial pain intensitypre-interventionmean of orofacial pain in the last seven days evaluated 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 disorderspre-interventionEvaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Catastrophization of painpre-interventionEvaluation 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.
Kinesiophobiapre-interventionAssessment 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.
Impact of headachepre-interventionEvaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Sleep qualitypre-interventionAssessment 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.
Dizziness-related disabilitypre-interventionEvaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Neck pain-related disabilitypre-interventionAssessment of neck pain-related disability with Neck Disability Index (NDI)

Contacts

Primary ContactYolanda Castellote
mycastel@ujaen.es+34953213519

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026