Fatigue and Sleep in Children and Adolescents With Juvenile Idiopathic Arthritis: A Cross-Sectional Study

August 1, 2018 updated by: Ela Tarakci, Istanbul University
The aims of this study is to primarily investigate fatigue and sleep and to secondarily examine possible relationships between disease activity, pain and functional ability in Turkish children and adolescents with Juvenile Idiopathic Arthritis (JIA).

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

96

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

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients attending the outpatient clinic of the Department of Pediatric Rheumatology, Medical Faculty of Cerrahpasa, Istanbul University, were recruited between February 2015 and December 2015 to participate in this study. All participants signed informed consent forms. The participants were volunteers who were examined by the pediatric rheumatologist who participated in the present study.

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

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

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

This is where you will find people and organizations involved with this 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, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

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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