Clinical trial NCT05732753: Mindfulness and Education in Patients With Non-oncological Orofacial Pain
Official title: Effects of a Program Based on Mindfulness Plus Pain Neurophysiology Education Versus a Pain Neurophysiology Education Program on Perceived Quality of Life, Pain, Sleep Quality, and Functionality in Adult Patients With Non-oncological Orofacial Pain .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oro-Facial-Digital Syndrome
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyze the effects of a program based on Mindfulness plus Pain Neurophysiology Education versus a program based on Pain Neurophysiology Education on perceived quality of life, pain, sleep quality, and functionality, in adult patients with non-cancer orofacial pain.

Detailed description: This research corresponds to an experimental study, a double-blind randomized controlled clinical trial, where a total of 50 men and women, over 18 years of age, will be evaluated, divided into two groups: the experimental group will receive a Mindfulness-based intervention, plus a program Education in Neurophysiology of Pain, lasting 8 weeks; and the control group will only receive an 8-week Pain Neurophysiology Education program.

The variables will be measured for both groups with the same validated tools and the same investigator to avoid information biases and differential incorrect classification. The evaluations will be carried out at the beginning of the intervention and immediately after the end of this period, and the results will be recorded in a data record that will later be unified in an Excel database, recording a code for each participant to maintain condition of privacy, but at the same time allow the required comparability.

For the independent variables, the sociodemographic characteristics will be addressed; On the other hand, the outcome variables will be the Health-Related Quality of Life \[HRQOL\] with the SF36 questionnaire, the Pittsburgh Index for sleep quality, the VAS scale for pain, and the Craniofacial Pain and Disability Inventory (CFPDI) for pain and functionality. Once the intervention is finished, the final evaluation will be carried out and from the comparative process define if there are significant differences with respect to the results initially obtained.

Eligibility criteria: Inclusion Criteria:

* Men and women older than 18 years, who voluntarily agree to participate in the study, with orofacial pain of more than 24 weeks of evolution, of non-oncological origin.

Exclusion Criteria:

* Oncological origin of orofacial pain. Systemic diseases with a focus on the TMJ. Patients operated on ATM. Population that does not agree to participate in the study or who at the time of entering the program have denied the endorsement of the use of their data for research in the informed consent.

Primary outcomes:
measure: Health-related quality of life [HRQoL] with the SF36 questionnaire
timeFrame: Up to twelve weeks
measure: Pain with VAS scale
timeFrame: Up to twelve weeks
measure: Pain and functionality with Craniofacial Pain and Disability Inventory (CF-PDI)
timeFrame: Up to twelve weeks
measure: Quality of sleep with the Pittsburgh Index
timeFrame: Up to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Maxillofacial Surgery service of the Hospitals: Virgen de las Nieves of Granada and Neurotraumatology of Jaén.
Study officials:
References: