FibromyalgiaCBNCT06634563
Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia
A study testing mindfulness meditation and cognitive behavioral training in people with Fibromyalgia, run by Cairo University.
Trial summary
this study will be conducted to investigate The Impact Of Adding Mindfulness Meditation to Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- mindfulness meditation and cognitive behavioral training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2024to 30 Apr 2025
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Confirmation of a clinical diagnosis of fibromyalgia by the patient's own physician.
- Wide spread pain for at least 3 months and tenderness at a minimum of 11of the 18 specific tender point sites.
- Age between 30 and 40 years.
- Female gender.
- BMI: 25-30 kg/m2
Who cannot join
- Pregnancy
- drug addicition
- Any current psychiatric disorder that would interfere with pro-gram adherence.
- Life-threatening disease
Trial locations and contacts
No sites are listed yet.
Dina A Abd El-salam, phd contact
About this study
this study will be conducted to investigate The Impact Of Adding Mindfulness Meditation to Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia.
Read the detailed description
Fibromyalgia syndrome (FMS) is a disorder characterized by chronic, widespread musculoskeletal pain. Muscle and joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, and generalized sensitivity are the main manifestations of this disease .Cognitive-behavioral training presents as an important therapeutic resource, as it is capable of modifying patient's negative thoughts and expectations, improving mood, stress, coping with pain and problem solving, including behavioral interventions that specifically deal with improving the fibromyalgia symptoms (sleep hygiene, re-laxation training, activity rhythm).Mindfulness meditation is the intentional effort to pay nonjudgmental attention to present-moment experiences and sustain this attention over time. The aim is to cultivate a stable and nonreactive present-moment awareness. Mindfulness Based Pain Management has been evaluated and showing significant positive changes in patients with chronic pain, with medium to large effect sizes on self-report measures of depression, positive outlook, pain acceptance. fifty women with fibromylagia will be assigned randomly to two groups; first one will receive mindfulness meditation for 30 minutes in addition to mobile application-based brain training program and the second one will receive mobile application-based brain training program alone
- Conditions
- Fibromyalgia
- Being tested
- mindfulness meditation, cognitive behavioral training
- Keywords
- Mindfulness Meditation, cognitive behavioral training, fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness meditationOther
the patients will receive mindfulness meditation in the form of Attention-focusing technique (body scan, directing attention throughout the body in a relaxed, supine state) guided by audiotapes. Relaxing every part of the body by guided audiotape from head to toes and Sitting meditation (systematically directing attention to breath) guided by audiotapes. Relaxing deep rhythmic breathing with concentration on every breath.
cognitive behavioral trainingOther
Training sessions will include three cognitive training tasks each of them target a particular core cognitive capability and are grouped into three categories by target domain: memory (working memory), attention (selective attention), and problem solving (logical reasoning) through these games (organic order and fuse clues for logical reasoning training, lost in migration, trouble brewing, assist ants and train of thought for attention training and memory match and memory match one drive for working memory training).
| Study group | Role | What they receive |
|---|---|---|
| mindfulness meditation | Experimental | Twenty five women in study group will receive mindfulness meditation for 30 minutes in addition to mobile application-based brain training program (cognitive behavioral training) for 30 minutes day after day for 8 weeks Receives: Other: mindfulness meditation; Other: cognitive behavioral training |
| cognitive behavioral training | Active comparator | Twenty five women in control group will receives mobile application-based brain training program (cognitive behavioral training) for 60 minutes day after day for 8 weeks. Receives: Other: cognitive behavioral training |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure threshold
The algometer with a rubber disc of 1 cm2 will be applied at a 90° vertical angle to all 18 tender point. Previous studies have shown pressure threshold measures obtained using algometer with 1 cm2 contact area to have acceptable interrater and intrarater reliability of pressure scores over time. Pressure will be steadily increased at a rate of approximately 1 kg per second, and each site will be tested in succession for each of two trials, allowing for recovery time between trials (approximately 10 minutes between retest at each point). Subjects will be instructed to indicate verbally when they first felt pain. The pressure will be then stopped, and the pressure will be recorded
Measured: up to eight weeks
severity of pain
The Visual Analogue Scale-Pain (VAS-Pain) will be used to assess pain. the patients will be asked to assess the severity of pain they experience at that moment on a 10-cm visual scale from 0 (no pain) to 10 (the most painful possible).
Measured: up to eight weeks
cognition assessment
Reha-Com device will be used to assess cognition. it containing the (attention and concentration) program was utilized as the patient is asked to concentrate on every detail in the separately presented picture and select the one that resembles it in every detail from the matrix, as the assessment screen is splitted into two parts. One portion represents the matrix that involves: according to (24) levels of difficulty: 3 pictures (1 by 3 matrix), 6 pictures (2 by 3 matrix) as well as 9 pictures (3 by 3 matrix), and the other part represents the separated picture. Reha-Com devicealso containing the (Memory) program. The test is divided into three different \"modules\" according to levels of difficulty. Every module is represented by a distinct task the \"player\" is asked to perform: memorizing all cards (Storage systems), memorizing cards selectively (Selective attention) and sorting cards (Central executive).
Measured: up to eight weeks
Secondary outcomes (1)
life disability
The revised Fibromyalgia Impact Questionnaire will be used to assess quality of life. It consists of 21-items, 11-point numerical rating scales (0-10) designed to evaluate three main domains in relation to the previous week: physical function (9 items), overall impact (2 items) and FM symptoms (10 items). It is also available in arabic version. The Arabic version of the FIQ-A has an acceptable reliability and validity criteria. It can be used for clinical practice and research use in the Arabic-speaking population
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start12 Oct 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Mindfulness Meditation and cognitive behavioral training
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abd el Aziz Abd el Salam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634563
- Sponsor's protocol ID
- P.T.REC/012/005340
- Acronym
- CB
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia
- ClinicalTrials.gov ID
- NCT06634563
- Acronym / sponsor ID
- CB / P.T.REC/012/005340
- Conditions
- Fibromyalgia
- Keywords
- Mindfulness Meditation, cognitive behavioral training, fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Oct 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
this study will be conducted to investigate The Impact Of Adding Mindfulness Meditation to Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia.
Detailed description
Fibromyalgia syndrome (FMS) is a disorder characterized by chronic, widespread musculoskeletal pain. Muscle and joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, and generalized sensitivity are the main manifestations of this disease .Cognitive-behavioral training presents as an important therapeutic resource, as it is capable of modifying patient's negative thoughts and expectations, improving mood, stress, coping with pain and problem solving, including behavioral interventions that specifically deal with improving the fibromyalgia symptoms (sleep hygiene, re-laxation training, activity rhythm).Mindfulness meditation is the intentional effort to pay nonjudgmental attention to present-moment experiences and sustain this attention over time. The aim is to cultivate a stable and nonreactive present-moment awareness. Mindfulness Based Pain Management has been evaluated and showing significant positive changes in patients with chronic pain, with medium to large effect sizes on self-report measures of depression, positive outlook, pain acceptance. fifty women with fibromylagia will be assigned randomly to two groups; first one will receive mindfulness meditation for 30 minutes in addition to mobile application-based brain training program and the second one will receive mobile application-based brain training program alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Mindfulness Meditation and cognitive behavioral training
| Arm | Type | Receives |
|---|---|---|
| mindfulness meditation | Experimental | Other: mindfulness meditation, Other: cognitive behavioral trainingTwenty five women in study group will receive mindfulness meditation for 30 minutes in addition to mobile application-based brain training program (cognitive behavioral training) for 30 minutes day after day for 8 weeks |
| cognitive behavioral training | Active comparator | Other: cognitive behavioral trainingTwenty five women in control group will receives mobile application-based brain training program (cognitive behavioral training) for 60 minutes day after day for 8 weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Confirmation of a clinical diagnosis of fibromyalgia by the patient's own physician.
- Wide spread pain for at least 3 months and tenderness at a minimum of 11of the 18 specific tender point sites.
- Age between 30 and 40 years.
- Female gender.
- BMI: 25-30 kg/m2
Key exclusion criteria (4 listed)
- Pregnancy
- drug addicition
- Any current psychiatric disorder that would interfere with pro-gram adherence.
- Life-threatening disease
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 meditationthe patients will receive mindfulness meditation in the form of Attention-focusing technique (body scan, directing attention throughout the body in a relaxed, supine state) guided by audiotapes. Relaxing every part of the body by guided audiotape from head to toes and Sitting meditation (systematically directing attention to breath) guided by audiotapes. Relaxing deep rhythmic breathing with concentration on every breath. | Other | mindfulness meditation |
| cognitive behavioral trainingTraining sessions will include three cognitive training tasks each of them target a particular core cognitive capability and are grouped into three categories by target domain: memory (working memory), attention (selective attention), and problem solving (logical reasoning) through these games (organic order and fuse clues for logical reasoning training, lost in migration, trouble brewing, assist ants and train of thought for attention training and memory match and memory match one drive for working memory training). | Other | cognitive behavioral training, mindfulness meditation |
Primary outcome
pressure threshold
Time frame: up to eight weeks
The algometer with a rubber disc of 1 cm2 will be applied at a 90° vertical angle to all 18 tender point. Previous studies have shown pressure threshold measures obtained using algometer with 1 cm2 contact area to have acceptable interrater and intrarater reliability of pressure scores over time. Pressure will be steadily increased at a rate of approximately 1 kg per second, and each site will be tested in succession for each of two trials, allowing for recovery time between trials (approximately 10 minutes between retest at each point). Subjects will be instructed to indicate verbally when they first felt pain. The pressure will be then stopped, and the pressure will be recorded
severity of pain
Time frame: up to eight weeks
The Visual Analogue Scale-Pain (VAS-Pain) will be used to assess pain. the patients will be asked to assess the severity of pain they experience at that moment on a 10-cm visual scale from 0 (no pain) to 10 (the most painful possible).
cognition assessment
Time frame: up to eight weeks
Reha-Com device will be used to assess cognition. it containing the (attention and concentration) program was utilized as the patient is asked to concentrate on every detail in the separately presented picture and select the one that resembles it in every detail from the matrix, as the assessment screen is splitted into two parts. One portion represents the matrix that involves: according to (24) levels of difficulty: 3 pictures (1 by 3 matrix), 6 pictures (2 by 3 matrix) as well as 9 pictures (3 by 3 matrix), and the other part represents the separated picture. Reha-Com devicealso containing the (Memory) program. The test is divided into three different \"modules\" according to levels of difficulty. Every module is represented by a distinct task the \"player\" is asked to perform: memorizing all cards (Storage systems), memorizing cards selectively (Selective attention) and sorting cards (Central executive).
1 secondary outcome
life disability
Time frame: up to eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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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.
Dina A Abd El-salam, phd contact
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness meditation and cognitive behavioral training in people with Fibromyalgia, run by Cairo University.
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 5 inclusion and 4 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 10 Oct 2024. 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 Dina A Abd El-salam, phd (dominal2010.dena@gmial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure threshold (time frame: up to eight weeks). The study lists 3 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 10 Oct 2024.