MindfulnessNCT04765007
Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
A study testing mindfulness-based stress reduction and Minimal intervention in people with Mindfulness and Chronic Pain, run by University of Jaén.
Trial summary
Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mindfulness, Chronic Pain, Orofacial Pain
- What is being tested?
- mindfulness-based stress reduction and Minimal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2021to 7 Oct 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed of orofacial chronic pain by a physician.
Who cannot join
- Pain with oncologic origin
- Severe mental disorder
Trial locations and contacts
No sites are listed yet.
About this study
Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help patients to accept their problem and to cope it. In consequence, the present study is aimed to evaluate the efficacy of a mindfulness therapy program in management of chronic orofacial pain.
- Conditions
- Mindfulness, Chronic Pain, Orofacial Pain
- Being tested
- mindfulness-based stress reduction, Minimal intervention
- Keywords
- mindfulness, chronic pain, orofacial pain
- Medical subject headings
- Chronic Pain, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based stress reductionOther
Also called MBSR
Eight sessions of two hours and a half, one day per week during eight weeks. In addition, patients will perform a day of intensive silent practice of 6-8 hours of duration.
The content of each session balances three activities: the presentation of a topic, moments of dialogue and group exploration (using appreciative inquiry) and a Mindfulness practice.
The sessions will take place in online format, through the google meet application
Minimal interventionOther
A guided meditation program of eight weeks of duration will be provided to the patients and they will be informed about the procedure and the beneficial effects of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group | Experimental | This arm will be treated with a mindfulness-based stress reduction therapy. Receives: Other: mindfulness-based stress reduction |
| Control group | Other | This arm will be treated with a minimal intervention. Receives: Other: Minimal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
orofacial pain intensity
mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain.
Measured: pre-intervention
orofacial pain intensity
mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
Measured: 8 weeks
orofacial pain intensity
mean of orofacial pain in the last seven daysevaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
Measured: 5 months
Symptoms of temporomandibular disorders
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Measured: pre-intervention
Symptoms of temporomandibular disorders
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Measured: 8 weeks
Symptoms of temporomandibular disorders
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Measured: 5 months
Catastrophization of pain
Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Measured: pre-intervention
Catastrophization of pain
Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Measured: 8 weeks
Catastrophization of pain
Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Measured: 5 months
Kinesiophobia
Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Measured: pre-intervention
Kinesiophobia
Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Measured: 8 weeks
Kinesiophobia
Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Measured: 5 months
Impact of headache
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Measured: pre-intervention
Impact of headache
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Measured: 8 weeks
Impact of headache
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Measured: 5 months
Sleep quality
Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Measured: pre-intervention
Sleep quality
Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Measured: 8 weeks
Sleep quality
Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Measured: 5 months
Dizziness-related disability
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Measured: pre-intervention
Dizziness-related disability
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Measured: 8 weeks
Dizziness-related disability
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Measured: 5 months
Neck pain-related disability
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Measured: pre-intervention
Neck pain-related disability
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Measured: 8 weeks
Neck pain-related disability
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start4 May 2021 (estimated)
- Primary completion4 May 2021 (estimated)
- Study completion7 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Rodríguez Almagro, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765007
- Sponsor's protocol ID
- mindfulness Ujaen
- Status last verified
- Apr 2021
- First submitted
- 2 Feb 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
- ClinicalTrials.gov ID
- NCT04765007
- Acronym / sponsor ID
- mindfulness Ujaen
- Conditions
- Mindfulness, Chronic Pain, Orofacial Pain
- Keywords
- mindfulness, chronic pain, orofacial pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 4 May 2021 (estimated)
- Primary completion
- 4 May 2021 (estimated)
- Study completion
- 7 Oct 2021 (estimated)
- First posted
- 21 Feb 2021 (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.
Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help patients to accept their problem and to cope it. In consequence, the present study is aimed to evaluate the efficacy of a mindfulness therapy program in management of chronic orofacial pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Other: mindfulness-based stress reductionThis arm will be treated with a mindfulness-based stress reduction therapy. |
| Control group | Other | Other: Minimal interventionThis arm will be treated with a minimal intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed of orofacial chronic pain by a physician.
Key exclusion criteria (2 listed)
- Pain with oncologic origin
- Severe mental disorder
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-based stress reductionAlso: MBSREight sessions of two hours and a half, one day per week during eight weeks. In addition, patients will perform a day of intensive silent practice of 6-8 hours of duration. The content of each session balances three activities: the presentation of a topic, moments of dialogue and group exploration (using appreciative inquiry) and a Mindfulness practice. The sessions will take place in online format, through the google meet application | Other | Mindfulness group |
| Minimal interventionA guided meditation program of eight weeks of duration will be provided to the patients and they will be informed about the procedure and the beneficial effects of the therapy. | Other | Control group |
Primary outcome
orofacial pain intensity
Time frame: pre-intervention
mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain.
orofacial pain intensity
Time frame: 8 weeks
mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
orofacial pain intensity
Time frame: 5 months
mean of orofacial pain in the last seven daysevaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
Symptoms of temporomandibular disorders
Time frame: pre-intervention
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Symptoms of temporomandibular disorders
Time frame: 8 weeks
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Symptoms of temporomandibular disorders
Time frame: 5 months
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Catastrophization of pain
Time frame: pre-intervention
Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Catastrophization of pain
Time frame: 8 weeks
Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Catastrophization of pain
Time frame: 5 months
Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
Kinesiophobia
Time frame: pre-intervention
Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Kinesiophobia
Time frame: 8 weeks
Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Kinesiophobia
Time frame: 5 months
Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
Impact of headache
Time frame: pre-intervention
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Impact of headache
Time frame: 8 weeks
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Impact of headache
Time frame: 5 months
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Sleep quality
Time frame: pre-intervention
Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Sleep quality
Time frame: 8 weeks
Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Sleep quality
Time frame: 5 months
Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
Dizziness-related disability
Time frame: pre-intervention
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Dizziness-related disability
Time frame: 8 weeks
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Dizziness-related disability
Time frame: 5 months
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Neck pain-related disability
Time frame: pre-intervention
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Neck pain-related disability
Time frame: 8 weeks
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Neck pain-related disability
Time frame: 5 months
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
Related trials for Mindfulness
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
Physiology of Liberation
Psychophysiological Reactivity and Recovery
RecruitingPhase 2
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
Opioid Use Disorder
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.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based stress reduction and Minimal intervention in people with Mindfulness and Chronic Pain, run by University of Jaén.
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 2 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: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yolanda Castellote (+34953213519, mycastel@ujaen.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orofacial pain intensity (time frame: pre-intervention). The study lists 24 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 3 May 2021.