Mindfulness and Education in Patients With Non-oncological Orofacial Pain

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 .

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.

Study Overview

• Status: Completed
• Conditions: Oro-Facial-Digital Syndrome
• Intervention / Treatment: Other: Mindfulness + Education in Neurophysiology of 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	Other: Mindfulness + Education in Neurophysiology of pain; 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.
Active Comparator: Control group; The control group (CG) will receive an Education intervention, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive 8 sessions, 60' long, with a frequency of one session per week.	Other: Mindfulness + Education in Neurophysiology of pain; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and functionality with Craniofacial Pain and Disability Inventory (CF-PDI)	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.	Up to twelve weeks
Quality of sleep with the Pittsburgh Index	A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.	Up to twelve weeks
Health-related quality of life [HRQoL] with the SF36 questionnaire	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.	Up to twelve weeks
Pain with VAS scale	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.	Up to twelve weeks

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): May 29, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Abnormalities, Multiple; Chromosome Disorders; Bone Diseases, Developmental; Sex Chromosome Disorders; Dysostoses; Facial Pain; Orofaciodigital Syndromes
• Other Study ID Numbers: -University of Jaén-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No