- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04729218
The Movement Imagery Ability in Patients With Familial Mediterranean Fever
August 1, 2022 updated by: Albina Alikaj, Medipol University
Motor imagery is the mental representation of movement without any doing body movement.
A main function of imagery is to aid the self-regulation of thoughts, feelings, and behaviours.
Studies have shown to be more effective for individuals displaying a higher level of imagery ability when using imagery to improve motor and motivational outcomes, including self-efficacy.
The aim of this study is to measure the movement imagery ability in patients with Familial Mediterranean Fever and compare it with healthy individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Familial Mediterranean Fever (FMF) is an autosomal recessive disease characterized by recurrent and self-limited attacks of fever associated with abdominal, chest, and joint pain.
Previous studies have shown that individuals with FMF are more limited in terms of physical function than the normal population, and depression and anxiety are more common in these individuals.
Being a lifetime disease, quality of life, and mental health can be affected due to serious complications such as attack frequency, disease resistance, and sometimes amyloidosis.
Mental imagery is the ability to imaging the movement without doing the physical execution of the movement.
During the last years, mental imagery is used in clinical practice as a tool for the treatment of chronic pain.
Pain differs in patients with rheumatic diseases.
Stress is one of the predictors of pain in patients with FMF.
Even if the frequency is variable when attacks happen they may affect patients physically and their mental health and the ability to cope.
A main function of imagery is to aid the self-regulation of thoughts, feelings, and behaviors.
To use imagery for motor and motivational outcomes firstly the imagery ability levels should be measured.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Istanbul University, Cerrahpaşa Medical Faculty, Department of Rheumatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Familial Mediterranean Fever and Healthy Controls
Description
Inclusion Criteria:
- having had at least one attack last year
- co-operated individuals
Exclusion Criteria:
- patients with a neurological disorder,
- diagnosed with cancer,
- cognitive impairment,
- having a primary pathology of the musculoskeletal system,
- having previous imagery practice,
- having an additional rheumatic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Familial Mediterranean Fever group
30 participants
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Determining the movement imagery ability: internal visual, external visual and kinesthetic imagery
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|
Healthy group
30 participants
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Determining the movement imagery ability: internal visual, external visual and kinesthetic imagery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Imagery Questionnaire-3 (MIQ-3)
Time Frame: Baseline
|
It is a questionnaire containing 12 items to evaluate the visual imagination skills of the individual.
It evaluates internal visual imagery, external visual imagery, and kinesthetic imagery.
For each item, first of all, individuals read the description of the movement, and then it is desired to perform the movement physically and after that, the same movement is requested.
Individuals evaluate the degree of imagination on a 7-point Likert-type scale ranging from 1 (very difficult to see/feel) to 7 (very easy to see/feel).
The motion visualization questionnaire has good psychometric properties, internal reliability, and estimated validity.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
McGill Melzack Pain Questionnaire (MPQ)
Time Frame: Baseline
|
MPQ consists of 78 descriptors grouped into four categories: sensory, affective, evaluative, and miscellaneous.
These four categories were grouped into 20 subclasses each made up of 2 to 6 words according to pain intensity.
Patients were asked to choose the pain descriptors according to the type of pain they felt during the attack episodes.
Patients were instructed to choose one of the words that best described their type of pain experience.
Changing of pain with time was assessed.
Pain right now, pain at its worst and pain at its least was evaluated.
Pain exacerbating or relieving factors were recorded.
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Baseline
|
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Pain Catastrophizing Scale
Time Frame: Baseline
|
Pain Catastrophizing Scale identifies catastrophic thoughts or feelings and ineffective coping strategies of patients.
PCS is a Likert-type self-assessment scale consisting of thirteen items.
Each item is evaluated between 0 and 4 points.
The total score ranges from 0 to 52.
Includes rumination, magnification, and helplessness subscales.
High scores indicate that the level of disaster is high.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Albina Alikaj, MSc, Medipol University
- Study Chair: Ahsen Büyükaslan, MSc, Medipol University
- Study Director: Serdal Uğurlu, Prof, Istanbul University - Cerrahpasa (IUC)
- Study Director: Burcu Dilek, PhD, Acibadem University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
February 13, 2021
Study Completion (Actual)
February 18, 2021
Study Registration Dates
First Submitted
January 24, 2021
First Submitted That Met QC Criteria
January 24, 2021
First Posted (Actual)
January 28, 2021
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.399988
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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