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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04729218
Other study ID # 10840098-604.01.01-E.399988
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date February 18, 2021

Study information

Verified date August 2022
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 18, 2021
Est. primary completion date February 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
movement imagery ability
Determining the movement imagery ability: internal visual, external visual and kinesthetic imagery

Locations

Country Name City State
Turkey Istanbul University, Cerrahpasa Medical Faculty, Department of Rheumatology Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Medipol University Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Secondary 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. Baseline
Secondary 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. Baseline
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