Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04729218
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2021-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Movement Imagery Ability in Patients With Familial Mediterranean Fever
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010505', 'term': 'Familial Mediterranean Fever'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2021-01-24', 'studyFirstSubmitQcDate': '2021-01-24', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Movement Imagery Questionnaire-3 (MIQ-3)', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'McGill Melzack Pain Questionnaire (MPQ)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['movement imagery ability', 'pain', 'catastrophizing', 'familial mediterranean fever'], 'conditions': ['Familial Mediterranean Fever']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nsnjournal.org/article.asp?issn=2636-865X;year=2020;volume=37;issue=4;spage=221;epage=227;aulast=Dilek', 'label': 'Reliability and validity of the Turkish version of the movement imagery questionnaire-3: Its cultural adaptation and psychometric properties'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Familial Mediterranean Fever and Healthy Controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having had at least one attack last year\n* co-operated individuals\n\nExclusion Criteria:\n\n* patients with a neurological disorder,\n* diagnosed with cancer,\n* cognitive impairment,\n* having a primary pathology of the musculoskeletal system,\n* having previous imagery practice,\n* having an additional rheumatic disease'}, 'identificationModule': {'nctId': 'NCT04729218', 'briefTitle': 'The Movement Imagery Ability in Patients With Familial Mediterranean Fever', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'The Movement Imagery Ability in Patients With Familial Mediterranean Fever', 'orgStudyIdInfo': {'id': '10840098-604.01.01-E.399988'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Familial Mediterranean Fever group', 'description': '30 participants', 'interventionNames': ['Behavioral: movement imagery ability']}, {'label': 'Healthy group', 'description': '30 participants', 'interventionNames': ['Behavioral: movement imagery ability']}], 'interventions': [{'name': 'movement imagery ability', 'type': 'BEHAVIORAL', 'description': 'Determining the movement imagery ability: internal visual, external visual and kinesthetic imagery', 'armGroupLabels': ['Familial Mediterranean Fever group', 'Healthy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Cerrahpaşa Medical Faculty, Department of Rheumatology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Albina Alikaj, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}, {'name': 'Ahsen Büyükaslan, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Medipol University'}, {'name': 'Serdal Uğurlu, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}, {'name': 'Burcu Dilek, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acibadem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Albina Alikaj', 'investigatorAffiliation': 'Medipol University'}}}}