Multiple SclerosisMPIMSNCT07741864
Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis (MPIMS).
A study testing Mindfulness-based intervention and Educational intervention in people with Multiple Sclerosis and Pain, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate whether a mindfulness-based intervention is effective for reducing pain in adults with multiple sclerosis. It will also assess whether this intervention improves other symptoms commonly associated with pain, such as fatigue, sleep disturbances, anxiety, depression, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Pain, Pain Management
- What is being tested?
- Mindfulness-based intervention and Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years.
- Diagnosis of multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 1.0 and 7.0.
- Presence of pain.
- Ability to provide written informed consent.
Who cannot join
- Severe cognitive impairment.
- Diagnosed psychiatric disorders (e.g., schizophrenia or personality disorders).
- Participation in another non-pharmacological intervention specifically aimed at pain management.
- If receiving stable pain medication, treatment must have been maintained for at least 4 months before enrollment.
- Unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hopsital Universitario Virgen Macarena
Seville, Sevilla, 41009
Sara Eichau Madueño Doctor and PhD, PhD, 0034 600 162 917, uemac.hvm.sspa@juntadeandalucia.es
About this study
Official title: Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis
The goal of this clinical trial is to evaluate whether a mindfulness-based intervention is effective for reducing pain in adults with multiple sclerosis. It will also assess whether this intervention improves other symptoms commonly associated with pain, such as fatigue, sleep disturbances, anxiety, depression, and quality of life.
The main questions it aims to answer are:
Read more
- Does a mindfulness-based intervention reduce pain intensity in people with multiple sclerosis?
- Does the intervention improve fatigue, sleep quality, emotional well-being, quality of life?
- Does the effectiveness of the intervention differ according to the type of pain experienced by participants? Researchers will compare a mindfulness-based intervention with an educational program to determine whether mindfulness provides additional benefits for pain management in people with multiple sclerosis.
Participants will:
- Be randomly assigned to either the mindfulness intervention group or the educational control group.
- Complete assessments before the intervention, immediately after the intervention, and at 1-month and 3-month follow-up visits.
- If assigned to the mindfulness group, attend eight weekly 2.5-hour group sessions plus one 6-hour retreat, either in person or online.
- If assigned to the control group, attend two 2-hour educational sessions during the study period.
- Complete questionnaires evaluating pain, fatigue, physical function, anxiety, depression, sleep quality, quality of life, and mindfulness throughout the study.
- Conditions
- Multiple Sclerosis, Pain, Pain Management
- Being tested
- Mindfulness-based intervention, Educational intervention
- Keywords
- Multiple Sclerosis, Pain, Mindfulness
- Medical subject headings
- Multiple Sclerosis, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionOther
Group-based mindfulness intervention specifically designed for pain management in people with multiple sclerosis. The program includes pain neuroscience education, cognitive pain management strategies, guided meditation, active visualization techniques, mindfulness-based stretching exercises, and mindful yoga.The intervention consists of eight weekly group sessions lasting 2.5 hours each, followed by a 6-hour mindfulness retreat. Participants may attend the sessions either in person or online.
Educational interventionOther
Educational intervention consists of two 2-hour group sessions on multiple sclerosis and pain management, delivered once every 4 weeks during the 8-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Group | Experimental | Participants will receive a Mindfulness intervention specifically designed for pain management in people with multiple sclerosis. Receives: Other: Mindfulness-based intervention |
| Educational Group | Active comparator | Participants will receive an active educational intervention for pain management consisting of two group sessions Receives: Other: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
The intensity of pain will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported measure of pain intensity in which participants rate their current pain on an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Dimensions of pain
The dimensions of pain will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ is a 15-item instrument that assesses the qualitative characteristics of pain through 11 sensory and 4 affective descriptors, each rated on a 4-point scale from 0 (none) to 3 (severe). Total score ranges from 0 to 45, with higher scores indicating greater pain intensity and more severe pain qualities.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Impact of pain on daily functioning
The impact of pain on daily functioning will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ is a 10-item questionnaire designed to evaluate an individual's confidence in performing daily activities despite pain. Each item is rated on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely confident), yielding a total score from 0 to 60, with higher scores indicating greater pain self-efficacy.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Presence of neuropathic pain
The presence of neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire. The DN4 is a 10-item questionnaire consisting of 7 interview items assessing symptoms characteristic of neuropathic pain and 3 clinical examination items evaluating hypoesthesia to touch, hypoesthesia to pinprick, and pain evoked by brushing. Each item is scored as 0 (absent) or 1 (present), yielding a total score ranging from 0 to 10. A total score of ≥4 is indicative of neuropathic pain.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Emotional and cognitive impact of pain
The emotional and cognitive impact of pain will be assessed using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-administered questionnaire that assesses pain catastrophizing by evaluating negative thoughts and emotional responses associated with pain. It comprises three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time), yielding a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Severity of pain
The severity of pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self-report questionnaire that assesses pain severity, pain interference with daily activities, and pain characteristics. It consists of 9 items. Pain severity is assessed using four items rated on an 11-point numeric rating scale (0 = "no pain" to 10 = "pain as bad as you can imagine"), while pain interference is assessed using seven items rated from 0 ("does not interfere") to 10 ("completely interferes"). Higher scores indicate greater pain severity.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Secondary outcomes (9)
Physical function
Physical function will be assessed using the PROMIS-29 Profile, a patient-reported outcome measure that evaluates physical, mental, and social health, including physical function and pain interference. The PROMIS-29 consists of 29 items distributed across eight domains. The first seven domains are scored using a 5-point Likert scale, with four items per domain. The eighth domain assesses pain intensity using a single item scored on an 11-point numeric rating scale (0-10). Raw scores for each domain can be converted into standardized T-scores (mean = 50, SD = 10), with higher scores indicating more of the construct being measured.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Fatigue
Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), a patient-reported outcome measure that evaluates the impact of fatigue on physical, cognitive, and psychosocial functioning.The scale consists of 21 items, each rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The total score ranges from 0 to 84, with higher scores indicating greater fatigue.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a self-administered questionnaire that assesses the presence and severity of depressive symptoms over the previous two weeks. The questionnaire consists of 9 items rated on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Anxiety
Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), which assesses the severity of anxiety symptoms. It consists of seven items rated on a 4-point Likert scale (0 = "not at all" to 3 = "nearly every day"). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 0-4 indicate minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Sleep disturbance
Sleep disturbance will be assessed using the PROMIS Sleep Disturbance Short Form 6a (PROMIS-SD SF 6a). The PROMIS-SD SF 6a assesses the individual's subjective perception of sleep quality, sleep depth, and sleep restoration over the previous 7 days. It consists of six items rated on a 5-point Likert scale (1 = "very poor" to 5 = "very good"). Raw scores range from 6 to 30 and are converted into standardized T-scores (mean = 50, SD = 10). Higher T-scores indicate greater sleep disturbance (i.e., poorer sleep quality), whereas lower T-scores indicate better sleep quality.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Health-Related Quality of Life
Quality of life will be assessed using the Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL), which assesses health-related quality of life across nine domains in people with multiple sclerosis. It consists of 31 items and item is rated on a 5-point Likert scale (0 = "never" to 5 = "always"). Raw scores for each dimension and the overall score are transformed to a standardized scale ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Mindfulness
Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS) The MAAS is a self-report questionnaire that assesses the frequency with which individuals experience lapses in attention and awareness of the present moment. It consists of 15 items rated on a 6-point Likert scale (1 = "almost always" to 6 = "almost never"). The overall score is calculated as the mean of the 15 items, ranging from 1 to 6. Higher scores indicate greater dispositional mindfulness.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-administered questionnaire that assesses sleep quality and sleep patterns over the previous month. It consists of 19 self-rated items grouped into seven components. Each component is scored from 0 to 3 (0 = no difficulty, 3 = severe difficulty), yielding a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Dispositional mindfulness
Dispositional mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a self-report instrument and it consists of 39 items distributed across five dimensions: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Items are rated on a 5-point Likert scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true"). Total scores range from 39 to 195, with higher scores indicating greater mindfulness.
Measured: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start2 Sep 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Magni, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741864
- Sponsor's protocol ID
- SICEIA-2025-002466
- Acronym
- MPIMS
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cebolla A, García-Palacios A, Soler J, Guillen V, Baños R, Botella C. Propiedades psicométricas de la validación es-pañola del Cuestionario de las Cinco Facetas de Mindful-ness (FFMQ). European Journal of Psychiatry. 2012;26(2):118-126.
Cebolla A, Luciano JV, DeMarzo MP, Navarro-Gil M, Campayo JG. Psychometric properties of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in patients with fibromyalgia. Health Qual Life Outcomes. 2013 Jan 14;11:6. doi: 10.1186/1477-7525-11-6.
PubMed 2331730623. Macías Fernández JA, Royuela Rico A. La versión española del Índice de Calidad de Sueño de Pittsburgh. Informaciones Psiquiátricas. 1996;(146):465-472.
Full KM, Malhotra A, Crist K, Moran K, Kerr J. Assessing psychometric properties of the PROMIS Sleep Disturbance Scale in older adults in independent-living and continuing care retirement communities. Sleep Health. 2019 Feb;5(1):18-22. doi: 10.1016/j.sleh.2018.09.003. Epub 2018 Oct 28.
PubMed 30670160Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.
PubMed 20089179Beswick E, Quigley S, Macdonald P, Patrick S, Colville S, Chandran S, Connick P. The Patient Health Questionnaire (PHQ-9) as a tool to screen for depression in people with multiple sclerosis: a cross-sectional validation study. BMC Psychol. 2022 Nov 28;10(1):281. doi: 10.1186/s40359-022-00949-8.
PubMed 36443880Munguia-Izquierdo D, Segura-Jimenez V, Camiletti-Moiron D, Pulido-Martos M, Alvarez-Gallardo IC, Romero A, Aparicio VA, Carbonell-Baeza A, Delgado-Fernandez M. Multidimensional Fatigue Inventory: Spanish adaptation and psychometric properties for fibromyalgia patients. The Al-Andalus study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):94-102. Epub 2012 Dec 14.
PubMed 23261007Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
PubMed 19007576Ata E, Ozsoy-Unubol T, Demir S. Evaluation of Neuropathic Extremity Pain in Patients with Multiple Sclerosis. Noro Psikiyatr Ars. 2019 Oct 4;58(3):213-216. doi: 10.29399/npa.24802. eCollection 2021.
PubMed 34526844Lazaro C, Caseras X, Whizar-Lugo VM, Wenk R, Baldioceda F, Bernal R, Ovalle A, Torrubia R, Banos JE. Psychometric properties of a Spanish version of the McGill Pain Questionnaire in several Spanish-speaking countries. Clin J Pain. 2001 Dec;17(4):365-74. doi: 10.1097/00002508-200112000-00012.
PubMed 11783818Ehde DM, Nitsch KP, Smiley JP. Measurement characteristics and clinical utility of the Brief Pain Inventory-Short Form for individuals with multiple sclerosis. Rehabil Psychol. 2015 Nov;60(4):365-6. doi: 10.1037/rep0000065.
PubMed 26618216Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
PubMed 25844555Kos D, Raeymaekers J, Van Remoortel A, D'hooghe MB, Nagels G, D'Haeseleer M, Peeters E, Dams T, Peeters T. Electronic visual analogue scales for pain, fatigue, anxiety and quality of life in people with multiple sclerosis using smartphone and tablet: a reliability and feasibility study. Clin Rehabil. 2017 Sep;31(9):1215-1225. doi: 10.1177/0269215517692641. Epub 2017 Feb 17.
PubMed 28786335Senders A, Hanes D, Bourdette D, Carson K, Marshall LM, Shinto L. Impact of mindfulness-based stress reduction for people with multiple sclerosis at 8 weeks and 12 months: A randomized clinical trial. Mult Scler. 2019 Jul;25(8):1178-1188. doi: 10.1177/1352458518786650. Epub 2018 Jul 9.
PubMed 29985095Hughes CM, Smyth S, Lowe-Strong AS. Reflexology for the treatment of pain in people with multiple sclerosis: a double-blind randomised sham-controlled clinical trial. Mult Scler. 2009 Nov;15(11):1329-38. doi: 10.1177/1352458509345916. Epub 2009 Oct 13.
PubMed 19825891
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07741864
- Acronym / sponsor ID
- MPIMS / SICEIA-2025-002466
- Conditions
- Multiple Sclerosis, Pain, Pain Management
- Keywords
- Multiple Sclerosis, Pain, Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Aug 2026 (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.
The goal of this clinical trial is to evaluate whether a mindfulness-based intervention is effective for reducing pain in adults with multiple sclerosis. It will also assess whether this intervention improves other symptoms commonly associated with pain, such as fatigue, sleep disturbances, anxiety, depression, and quality of life.
The main questions it aims to answer are:
- Does a mindfulness-based intervention reduce pain intensity in people with multiple sclerosis?
- Does the intervention improve fatigue, sleep quality, emotional well-being, quality of life?
- Does the effectiveness of the intervention differ according to the type of pain experienced by participants? Researchers will compare a mindfulness-based intervention with an educational program to determine whether mindfulness provides additional benefits for pain management in people with multiple sclerosis.
Participants will:
- Be randomly assigned to either the mindfulness intervention group or the educational control group.
- Complete assessments before the intervention, immediately after the intervention, and at 1-month and 3-month follow-up visits.
- If assigned to the mindfulness group, attend eight weekly 2.5-hour group sessions plus one 6-hour retreat, either in person or online.
- If assigned to the control group, attend two 2-hour educational sessions during the study period.
- Complete questionnaires evaluating pain, fatigue, physical function, anxiety, depression, sleep quality, quality of life, and mindfulness throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Group | Experimental | Other: Mindfulness-based interventionParticipants will receive a Mindfulness intervention specifically designed for pain management in people with multiple sclerosis. |
| Educational Group | Active comparator | Other: Educational interventionParticipants will receive an active educational intervention for pain management consisting of two group sessions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years.
- Diagnosis of multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 1.0 and 7.0.
- Presence of pain.
- Ability to provide written informed consent.
Key exclusion criteria (5 listed)
- Severe cognitive impairment.
- Diagnosed psychiatric disorders (e.g., schizophrenia or personality disorders).
- Participation in another non-pharmacological intervention specifically aimed at pain management.
- If receiving stable pain medication, treatment must have been maintained for at least 4 months before enrollment.
- Unwillingness to provide 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-based interventionGroup-based mindfulness intervention specifically designed for pain management in people with multiple sclerosis. The program includes pain neuroscience education, cognitive pain management strategies, guided meditation, active visualization techniques, mindfulness-based stretching exercises, and mindful yoga.The intervention consists of eight weekly group sessions lasting 2.5 hours each, followed by a 6-hour mindfulness retreat. Participants may attend the sessions either in person or online. | Other | Mindfulness Group |
| Educational interventionEducational intervention consists of two 2-hour group sessions on multiple sclerosis and pain management, delivered once every 4 weeks during the 8-week intervention period. | Other | Educational Group |
Primary outcome
Intensity of pain
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The intensity of pain will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported measure of pain intensity in which participants rate their current pain on an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Dimensions of pain
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The dimensions of pain will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ is a 15-item instrument that assesses the qualitative characteristics of pain through 11 sensory and 4 affective descriptors, each rated on a 4-point scale from 0 (none) to 3 (severe). Total score ranges from 0 to 45, with higher scores indicating greater pain intensity and more severe pain qualities.
Impact of pain on daily functioning
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The impact of pain on daily functioning will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ is a 10-item questionnaire designed to evaluate an individual's confidence in performing daily activities despite pain. Each item is rated on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely confident), yielding a total score from 0 to 60, with higher scores indicating greater pain self-efficacy.
Presence of neuropathic pain
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The presence of neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire. The DN4 is a 10-item questionnaire consisting of 7 interview items assessing symptoms characteristic of neuropathic pain and 3 clinical examination items evaluating hypoesthesia to touch, hypoesthesia to pinprick, and pain evoked by brushing. Each item is scored as 0 (absent) or 1 (present), yielding a total score ranging from 0 to 10. A total score of ≥4 is indicative of neuropathic pain.
Emotional and cognitive impact of pain
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The emotional and cognitive impact of pain will be assessed using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-administered questionnaire that assesses pain catastrophizing by evaluating negative thoughts and emotional responses associated with pain. It comprises three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time), yielding a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
Severity of pain
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
The severity of pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self-report questionnaire that assesses pain severity, pain interference with daily activities, and pain characteristics. It consists of 9 items. Pain severity is assessed using four items rated on an 11-point numeric rating scale (0 = "no pain" to 10 = "pain as bad as you can imagine"), while pain interference is assessed using seven items rated from 0 ("does not interfere") to 10 ("completely interferes"). Higher scores indicate greater pain severity.
9 secondary outcomes
Physical function
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Fatigue
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Depressive symptoms
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Anxiety
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Sleep disturbance
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Health-Related Quality of Life
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Mindfulness
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Sleep quality
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Dispositional mindfulness
Time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- BackgroundCebolla A, García-Palacios A, Soler J, Guillen V, Baños R, Botella C. Propiedades psicométricas de la validación es-pañola del Cuestionario de las Cinco Facetas de Mindful-ness (FFMQ). European Journal of Psychiatry. 2012;26(2):118-126.
- Background: PubMed 23317306Cebolla A, Luciano JV, DeMarzo MP, Navarro-Gil M, Campayo JG. Psychometric properties of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in patients with fibromyalgia. Health Qual Life Outcomes. 2013 Jan 14;11:6. doi: 10.1186/1477-7525-11-6.
- Background23. Macías Fernández JA, Royuela Rico A. La versión española del Índice de Calidad de Sueño de Pittsburgh. Informaciones Psiquiátricas. 1996;(146):465-472.
- Background: PubMed 30670160Full KM, Malhotra A, Crist K, Moran K, Kerr J. Assessing psychometric properties of the PROMIS Sleep Disturbance Scale in older adults in independent-living and continuing care retirement communities. Sleep Health. 2019 Feb;5(1):18-22. doi: 10.1016/j.sleh.2018.09.003. Epub 2018 Oct 28.
- Background: PubMed 20089179Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.
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- 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.
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-based intervention and Educational intervention in people with Multiple Sclerosis and Pain, run by Hospital Universitario Virgen Macarena 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Magni, MSc (622623602, magni@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07741864, which also lists 24 linked publications.
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 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.