Mindfulness and Education in Patients With Non-oncological Orofacial Pain

NCT ID: NCT05732753

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2023-06-05

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.

Conditions

Oro-Facial-Digital Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness + Education in Neurophysiology of pain

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness + Education in Neurophysiology of pain

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Agustín Aibar Almazán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Jaén, , Spain

Countries

Spain

Other Identifiers

-University of Jaén-

Identifier Type: -

Identifier Source: org_study_id