Emotional Intelligence and Chronic Orofacial Pain (IEDOF)

June 15, 2026 updated by: University Hospital, Brest
Chronic pain, lasting more than three months, is a widespread health issue that negatively impacts daily life, leading to significant emotional distress and functional impairment. Emotional intelligence, defined as the ability to recognize and manage one's own emotions as well as those of others, has been linked to better communication skills and reduced stress, which is a well-known risk factor for chronic pain. Studies have highlighted a correlation between emotional intelligence and certain chronic pain conditions, such as fibromyalgia and migraines. However, no research has yet explored its role in painful temporomandibular disorders (TMD). Given the strong involvement of psychosocial factors in TMD etiology, a better understanding of these elements could improve pain management and pave the way for preventive interventions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project aims to compare emotional intelligence and various psychosocial factors (anxiety, depression, coping, emotional regulation) between patients with painful temporomandibular disorder (TMD) and a control group without TMD or chronic pain. The study is based on the administration of validated French-language questionnaires during routine dental medicine consultations. Each participant completes these questionnaires in approximately 15 minutes, without any modification to their care. The data collected will help assess the relationships between orofacial pain and emotional factors to improve the understanding and management of affected patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Regarding the evaluated population (cases), approximately 30 patients are seen each week in the oral health service for chronic orofacial pain consultations. About 60% of these patients have a diagnosis of painful TMD, which is around 18 patients per week. Including 44 patients in this study over a 6-month period thus seems feasible.

Regarding the control population, more than 50 patients are seen daily in oral rehabilitation consultations at the oral health service of the CHU de Brest. These controls will be matched in gender and age (+/- 5 years) with the studied population (cases). The significant proportion of these patients should allow for the feasibility of this matching.

Description

Inclusion Criteria:

For all subjects:

Major subject

  • Non-opposition obtained
  • For subjects in the TMD group:

Diagnosis of temporomandibular dysfunction -No other diagnosis of chronic pain

For subjects in the control group:

-No diagnosis of chronic pain

Non inclusion Criteria:

  • Subject not understanding French
  • Subject under legal protection (guardianship or curatorship)
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Evaluation of the potential link between emotional intelligence and chronic orofacial pain.
All included subjects will have the same participation, which consists of completing several standardized questionnaires. These questionnaires assess various psychological and emotional aspects, including anxiety and depressive disorders (HADS questionnaire), coping strategies (Brief-COPE score), emotional regulation (ERS score), fatigue level (EVA scale), and emotional intelligence (TEIQue-SF questionnaire) to compare scores between the DTM group and the control group. Additionally, sociodemographic and psychosocial criteria will be collected to refine the analysis of the results. The completion of these questionnaires is part of routine consultations and does not alter the patients' standard care.
Other: Questionnaire and Physical Exam

All included subjects will be required to complete the following questionnaires:

Hospital Anxiety and Depression Scale (HADS) Brief-COPE for coping assessment Emotion Reactivity Scale (ERS) for emotional regulation Visual Analog Scale (VAS) for fatigue assessment Sociodemographic and psychosocial evaluation Trait Emotional Intelligence Questionnaire - Short Form (TEIQue-SF) for emotional intelligence assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of emotional intelligence score between both groups
Time Frame: Day 0

Measurement of emotional intelligence score assessed by the TEIQue-SF questionnaire :

The short version consists of 33 items assessing four factors: well-being, self-control, emotionality, and sociability. Each item is rated on a Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of anxiety disorders between both groups
Time Frame: Day 0

Measurement of anxiety disorders between the two groups via the HAD-S questionnaire

The HAD scale is a validated instrument in French, used to screen for anxiety and depressive disorders. It consists of 14 items scored from 0 to 3. Seven questions relate to anxiety (total A) and the other seven to the depressive dimension (total D), thus providing two scores (maximum score for each = 21). This questionnaire is routinely used during consultations in the oral health service and systematically used during specialized consultations for orofacial pain.
Day 0
Measurement of the coping score between both groups
Time Frame: Day 0

Measurement of the coping score assessed by the Brief-COPE questionnaire

This instrument is an abbreviated version of the COPE inventory with 28 items. It includes 14 scales that assess distinct dimensions of coping: active coping, planning, instrumental social support seeking, emotional social support seeking, emotional expression, behavioral disengagement, distraction, blaming, positive reinterpretation, humor, denial, acceptance, religion, and substance use.
Day 0
Measurement of emotional regulation score between both groups
Time Frame: Day 0

Measurement of emotional regulation score assessed by the ERS questionnaire

The ERS is a self-report questionnaire with 21 items designed to measure, using a single tool, three dimensions of emotional reactivity: emotional sensitivity, intensity, and persistence of emotions. Each item is rated on a Likert scale ranging from 0 ("does not apply to me at all") to 4 ("applies to me perfectly").
Day 0
Measurement of fatigue score between both groups
Time Frame: Day 0
Measurement of fatigue score assessed by an EVA scale (From 0 to 10)
Day 0
Measurement of Depression disorders between both groups
Time Frame: Day 0

Measurement of depression disorders between both groups via the HAD-S questionnaire

The HAD scale is a validated instrument in French, used to screen for anxiety and depressive disorders. It consists of 14 items scored from 0 to 3. Seven questions relate to anxiety (total A) and the other seven to the depressive dimension (total D), thus providing two scores (maximum score for each = 21). This questionnaire is routinely used during consultations in the oral health service and systematically used during specialized consultations for orofacial pain.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29BRC24.0372
  • 2025-A00682-47 (Registry Identifier: ANSM - IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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