- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03618680
Fatigue and Sleep in Children and Adolescents With Juvenile Idiopathic Arthritis: A Cross-Sectional Study
Study Overview
Status
Conditions
Detailed Description
Children with JIA become fatigued easily, experience joint inflammation, pain, limited mobility and report poor sleep quality and daytime sleepiness . It is reported in the literature that children with JIA suffer from poor sleep, parasomnias, daytime sleepiness, sleep fragmentation, cyclic alternating patterns increase, and sleep-disordered breathing compared to healthy children. Sleep was disturbed in almost half of the patients with both JIA and juvenile dermatomyositis, and that sleep disturbance and fatigue were both correlated with disease activity. Increased pain is associated with more sleep disturbance and more fatigue, and these appear to negatively influence quality of life.
So, in this study, fatigue and sleep in Turkish patients with JIA will be investigated by using specific surveys and also secondarily it will be examined possible relationships between disease activity, pain and functional ability in children and adolescents with JIA.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria consisted of a diagnosis of JIA according to the International League of Associations for Rheumatology (ILAR) criteria (13), being aged between 6 - 18 years, and being able to read and write in the Turkish language. All patients were diagnosed as JIA 6 months prior to the study.
Exclusion Criteria:
- Patients were excluded from study if they had a second rheumatic or another chronic disease, a history of mental deficit or psychological problem or no acceptance for participation in the study by their families.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale
Time Frame: baseline
|
Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale" (PedsQL-F) is a valid and reliable tool, and can be used to measure symptom-specific fatigue among patients with JIA .
Fatigue symptoms will be assessed by the PedsQL-F which is an 18-item questionnaire and is designed to measure child and parent's perception of fatigue in pediatric patients and comprises the general fatigue scale (6 items), sleep/rest fatigue scale (6 items) and cognitive fatigue scale (6 items).
Higher scores indicate higher quality of life.
|
baseline
|
|
Pittsburgh Sleep Quality Index
Time Frame: baseline
|
Sleep quality will be evaluated with Pittsburgh Sleep Quality Index (PSQI).
PSQI is a 23 item questionnaire that generates scales reflecting daytime dysfunction, sleep latency, disturbance, duration, quality and efficiency.
As the score increases, sleep quality decreases and daytime dysfunction due to sleep quality disorder increases.
PSQI is composed of three main scores: total PSQI score, PSQI sub-scores and sleep quality status score.
Each component is scored from 0 to 3, leading to a global PSQI score between 0 and 21, with higher scores indicating lower quality of sleep.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childhood Health Assessment Questionnaire
Time Frame: baseline
|
Functional ability will be assessed using The Turkish version of the Childhood Health Assessment Questionnaire (CHAQ).
CIn 8 activities (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), a number of questions were answered and scored on a scale of 0 - 3, where 0 = able to do with no difficulty, 1 = able to do with some difficulty, 2 = able to do with much difficulty, and 3 = unable to do.
The mean of the 8 scores identified the CHAQ score (range, 0 - 3).
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A29/03.Feb.2015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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