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Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia

Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06634563
Acronym
CB
Enrollment
50
Registered
2024-10-10
Start date
2024-10-12
Completion date
2025-04-30
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Mindfulness Meditation, cognitive behavioral training, fibromyalgia

Brief 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.

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

Interventions

OTHERmindfulness meditation

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.

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).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

opaque sealed envelope

Intervention model description

Mindfulness Meditation and cognitive behavioral training

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Pregnancy * drug addicition * Any current psychiatric disorder that would interfere with pro-gram adherence. * Life-threatening disease

Design outcomes

Primary

MeasureTime frameDescription
pressure thresholdup to eight weeksThe 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 painup to eight weeksThe 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 assessmentup to eight weeksReha-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).

Secondary

MeasureTime frameDescription
life disabilityup to eight weeksThe 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

Contacts

Primary ContactDina A Abd El-salam, phd
dominal2010.dena@gmial.com
Backup Contactdina A Abd El-salam, Phd
dominal2010.dena@gmial.com0201067750480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026