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Completed

NCT Number: NCT03618680

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

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).

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2018
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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