Oro-Facial-Digital SyndromeNCT05732753
Mindfulness and Education in Patients With Non-oncological Orofacial Pain
A study testing Mindfulness + Education in Neurophysiology of pain in people with Oro-Facial-Digital Syndrome, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oro-Facial-Digital Syndrome
- What is being tested?
- Mindfulness + Education in Neurophysiology of pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2023to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Maxillofacial Surgery service of the Hospitals: Virgen de las Nieves of Granada and Neurotraumatology of Jaén.
Jaén
About this study
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 .
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.
Read the 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
- Being tested
- Mindfulness + Education in Neurophysiology of pain
- Medical subject headings
- Orofaciodigital Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness + Education in Neurophysiology of painOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Mindfulness + Education in Neurophysiology of pain |
| Control group | Active comparator | 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. Receives: Other: Mindfulness + Education in Neurophysiology of pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to twelve weeks
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.
Measured: 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.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start3 Apr 2023
- Primary completion29 May 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oro-Facial-Digital SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732753
- Sponsor's protocol ID
- -University of Jaén-
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT05732753
- Acronym / sponsor ID
- -University of Jaén-
- Conditions
- Oro-Facial-Digital Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Mindfulness + Education in Neurophysiology of painAn 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 | Active comparator | Other: Mindfulness + Education in Neurophysiology of painThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness + Education in Neurophysiology of painAn 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 | Control group, Experimental group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness + Education in Neurophysiology of pain in people with Oro-Facial-Digital Syndrome, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life [HRQoL] with the SF36 questionnaire (time frame: Up to twelve weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.