Familial Mediterranean FeverNCT04729218
The Movement Imagery Ability in Patients With Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Mediterranean Fever
- What is being tested?
- movement imagery ability
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 18 Feb 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Familial Mediterranean Fever and Healthy Controls
Who may be able to join
- having had at least one attack last year
- co-operated individuals
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Cerrahpaşa Medical Faculty, Department of Rheumatology
Istanbul
About this study
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.
Read the 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.
- Conditions
- Familial Mediterranean Fever
- Being tested
- movement imagery ability
- Keywords
- movement imagery ability, pain, catastrophizing, familial mediterranean fever
- Medical subject headings
- Familial Mediterranean Fever, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
movement imagery abilityBehavioural
Determining the movement imagery ability: internal visual, external visual and kinesthetic imagery
| Study group | Role | What they receive |
|---|---|---|
| Familial Mediterranean Fever group | 30 participants Receives: Behavioral: movement imagery ability | |
| Healthy group | 30 participants Receives: Behavioral: movement imagery ability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Imagery Questionnaire-3 (MIQ-3)
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.
Measured: Baseline
Secondary outcomes (2)
McGill Melzack Pain Questionnaire (MPQ)
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.
Measured: Baseline
Pain Catastrophizing Scale
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Jan 2018
- Primary completion13 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Albina Alikaj, Medipol University
- Investigators
- Albina Alikaj, MSc, Principal investigator, Medipol UniversityAhsen Büyükaslan, MSc, Study chair, Medipol UniversitySerdal Uğurlu, Prof, Study director, Istanbul University - CerrahpasaBurcu Dilek, PhD, Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729218
- Sponsor's protocol ID
- 10840098-604.01.01-E.399988
- Status last verified
- Aug 2022
- First submitted
- 24 Jan 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Movement Imagery Ability in Patients With Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT04729218
- Acronym / sponsor ID
- 10840098-604.01.01-E.399988
- Conditions
- Familial Mediterranean Fever
- Keywords
- movement imagery ability, pain, catastrophizing, familial mediterranean fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 13 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 28 Jan 2021 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familial Mediterranean Fever group | – | Behavioral: movement imagery ability30 participants |
| Healthy group | – | Behavioral: movement imagery ability30 participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Familial Mediterranean Fever and Healthy Controls
Key inclusion criteria (2 listed)
- having had at least one attack last year
- co-operated individuals
Key exclusion criteria (6 listed)
- patients with a neurological disorder,
- diagnosed with cancer,
- cognitive impairment,
- having a primary pathology of the musculoskeletal system,
- having previous imagery practice,
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 |
|---|---|---|
| movement imagery abilityDetermining the movement imagery ability: internal visual, external visual and kinesthetic imagery | Behavioural | Familial Mediterranean Fever group, Healthy group |
Primary outcome
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.
2 secondary outcomes
McGill Melzack Pain Questionnaire (MPQ)
Time frame: Baseline
Pain Catastrophizing Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Reliability and validity of the Turkish version of the movement imagery questionnaire-3: Its cultural adaptation and psychometric propertiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Familial Mediterranean Fever
RecruitingObservational study
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Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
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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.
Albina Alikaj, MSc principal investigator
Medipol University
Ahsen Büyükaslan, MSc study chair
Medipol University
Serdal Uğurlu, Prof study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Mediterranean Fever, run by Medipol University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Imagery Questionnaire-3 (MIQ-3) (time frame: Baseline). 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 2 Aug 2022.