NCT Number: NCT06634563
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.
Trial opening soon.
Get Notified30 year–40 year
Female
Interventional
Not applicable
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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
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).
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).
Time frame: up to eight weeks
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
Contact information is provided by the study sponsor or research team.
Dina A Abd El-salam, phd
CONTACT
dina A Abd El-salam, Phd
CONTACT
Cairo University
Other
Acronym: CB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07738926
Fibromyalgia, Fibromyalgia Syndrome
Genova, Italy
View Trial DetailsNCT07722923
Fibromyalgia, Muscular Diseases
View Trial DetailsNCT07611539
Fibromyalgia, Muscular Diseases
View Trial DetailsNCT07680621
Fibromyalgia, Muscular Diseases
Sakarya, Turkey (Türkiye)
View Trial Details