Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia
CB
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedStudy Start
First participant enrolled
October 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedOctober 10, 2024
October 1, 2024
7 months
October 8, 2024
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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).
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).
up to eight weeks
Secondary Outcomes (1)
life disability
up to eight weeks
Study Arms (2)
mindfulness meditation
EXPERIMENTALTwenty 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 COMPARATORTwenty 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- drug addicition
- Any current psychiatric disorder that would interfere with pro-gram adherence.
- Life-threatening disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- opaque sealed envelope
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principale investigator dina abd el-aziz
Study Record Dates
First Submitted
October 8, 2024
First Posted
October 10, 2024
Study Start
October 12, 2024
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
October 10, 2024
Record last verified: 2024-10