Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
Primary Purpose
Mindfulness, Chronic Pain, Orofacial Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mindfulness-based stress reduction
Minimal intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mindfulness focused on measuring mindfulness, chronic pain, orofacial pain
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed of orofacial chronic pain by a physician.
Exclusion Criteria:
- Pain with oncologic origin
- Severe mental disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mindfulness group
Control group
Arm Description
This arm will be treated with a mindfulness-based stress reduction therapy.
This arm will be treated with a minimal intervention.
Outcomes
Primary Outcome Measures
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.
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
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
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).
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).
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).
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.
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.
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.
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.
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.
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.
Impact of headache
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Impact of headache
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Impact of headache
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
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.
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.
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.
Dizziness-related disability
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Dizziness-related disability
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Dizziness-related disability
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Neck pain-related disability
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Neck pain-related disability
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Neck pain-related disability
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04765007
Brief Title
Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
Official Title
Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2021 (Anticipated)
Primary Completion Date
May 4, 2021 (Anticipated)
Study Completion Date
October 7, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Chronic Pain, Orofacial Pain
Keywords
mindfulness, chronic pain, orofacial pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness group
Arm Type
Experimental
Arm Description
This arm will be treated with a mindfulness-based stress reduction therapy.
Arm Title
Control group
Arm Type
Other
Arm Description
This arm will be treated with a minimal intervention.
Intervention Type
Other
Intervention Name(s)
mindfulness-based stress reduction
Other Intervention Name(s)
MBSR
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Minimal intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
orofacial pain intensity
Description
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.
Time Frame
pre-intervention
Title
orofacial pain intensity
Description
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
Time Frame
8 weeks
Title
orofacial pain intensity
Description
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
Time Frame
5 months
Title
Symptoms of temporomandibular disorders
Description
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Time Frame
pre-intervention
Title
Symptoms of temporomandibular disorders
Description
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Time Frame
8 weeks
Title
Symptoms of temporomandibular disorders
Description
Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
Time Frame
5 months
Title
Catastrophization of pain
Description
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.
Time Frame
pre-intervention
Title
Catastrophization of pain
Description
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.
Time Frame
8 weeks
Title
Catastrophization of pain
Description
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.
Time Frame
5 months
Title
Kinesiophobia
Description
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.
Time Frame
pre-intervention
Title
Kinesiophobia
Description
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.
Time Frame
8 weeks
Title
Kinesiophobia
Description
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.
Time Frame
5 months
Title
Impact of headache
Description
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Time Frame
pre-intervention
Title
Impact of headache
Description
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Time Frame
8 weeks
Title
Impact of headache
Description
Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
Time Frame
5 months
Title
Sleep quality
Description
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.
Time Frame
pre-intervention
Title
Sleep quality
Description
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.
Time Frame
8 weeks
Title
Sleep quality
Description
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.
Time Frame
5 months
Title
Dizziness-related disability
Description
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Time Frame
pre-intervention
Title
Dizziness-related disability
Description
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Time Frame
8 weeks
Title
Dizziness-related disability
Description
Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
Time Frame
5 months
Title
Neck pain-related disability
Description
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Time Frame
pre-intervention
Title
Neck pain-related disability
Description
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Time Frame
8 weeks
Title
Neck pain-related disability
Description
Assessment of neck pain-related disability with Neck Disability Index (NDI)
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed of orofacial chronic pain by a physician.
Exclusion Criteria:
Pain with oncologic origin
Severe mental disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yolanda Castellote
Phone
+34953213519
Email
mycastel@ujaen.es
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
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