Skip to main content
OpenTrials
Completed

NCT Number: NCT05732753

Mindfulness and Education in Patients With Non-oncological Orofacial Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oro-Facial-Digital Syndrome Abnormalities, Multiple Bone Diseases Bone Diseases, Developmental Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dysostoses Genetic Diseases, Inborn Musculoskeletal Abnormalities Musculoskeletal Diseases Orofaciodigital Syndromes Sex Chromosome Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maxillofacial Surgery service of the Hospitals: Virgen de las Nieves of Granada and Neurotraumatology of Jaén.

Jaén, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness + Education in Neurophysiology of pain

Other

An experimental group (GE) that after an initial evaluation and with their consent, will be subjected to a program that includes an intervention based on Mindfulness and an 8-week Education intervention, one day a week with a duration of 120 minutes. The sessions will be divided into two parts, a part of 60' of Mindfulness and another of 60' of Education. In the Mindfulness part, formal Meditation practices and conscious movements based on yoga will be carried out. In the Education part, participants will be instructed in concepts related to the basic neurophysiology of pain.

Primary outcomes

  1. Health-related quality of life [HRQoL] with the SF36 questionnaire

    Time frame: Up to twelve weeks

    Used extensively for assessing health-related quality of life. For each scale, responses to each question are coded and recoded, and the results are transferred to a 0-100 point scale. On this scale of 0-100 of the SF-36, the higher the score obtained, the better the state of health.

  2. Pain with VAS scale

    Time frame: Up to twelve weeks

    Scale used to help a person rate the intensity of certain sensations and feelings, such as pain. Depending on the cm indicated by the patient, the value of said self-report is extrapolated to a numerical value that will be: no pain=0; mild pain=1.2; moderate=3-5; intense=6-8; unbearable=9-10.

  3. Pain and functionality with Craniofacial Pain and Disability Inventory (CF-PDI)

    Time frame: Up to twelve weeks

    Questionnaire composed of 21 items, allows to improve the diagnosis in patients with primary and secondary headaches, and in those with temporomandibular disorders or some other orofacial pain.

  4. Quality of sleep with the Pittsburgh Index

    Time frame: Up to twelve weeks

    A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study 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 .

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.