Sleep & Pain in Juvenile Arthritis

The Hospital for Sick Children31 enrolled

Overview

Childhood arthritis is an important cause of pain for affected children and youth (adolescents). Many youth with arthritis also have trouble sleeping. They often struggle to sleep through the night, wake up earlier, and are sleepier during the day compared to healthy children. Our research group, among others, has shown a strong link between sleep and pain. The main purpose of this study is to assess the impact of changing sleeping patterns on pain, and disease activity, in teenagers with arthritis. We think that better sleep will directly lead to better health.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Arthritis, Juvenile

Interventions

Sleep Manipulation ProtocolBEHAVIORAL

A structured sleep duration intervention will be taught to patients

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient in the rheumatology clinic at SickKids * all subtypes of JIA, as per the ILAR criteria * a baseline pain score of ≥ 1 on a visual analogue scale * age from 12-18 years old * capable of providing informed consent form themselves, as judged by the clinical team Exclusion Criteria: * a known sleep disorder (e.g., obstructive sleep apnea, etc.) * a high probability of having obstructive sleep apnea as determined by the Pediatric Sleep Questionnaire * currently taking medication with the intent to impact sleep (e.g., zolpidem, benzodiazepines, etc.) * taking corticosteroids (which may adversely affect sleep) * obligations that require a bed time later than 10:00 pm or a wake time earlier than 5:30 am during the study period * daily consumption of \> 1 coffee or "energy drink" and/or \> 3 caffeinated carbonated beverages * do not speak/understand English with enough proficiency to complete all study related tasks, as judged by the clinical team

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Change in Pain as measured on the PROMIS Pain Interference Scale

Change in Pain as measured on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale. Scores can range from 0-100 with 100 representing the best possible outcome

Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2

Secondary Outcomes

Change in Pain as measured on the PROMIS Pain Behaviour Scale

Change in Pain as measured on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Behaviour Scale. Scores can range from 0-100 with 100 representing the best possible outcome

Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2

Pain as measured using the iCanCope with Pain app

Time frame: end of study (3 weeks)

Change in Disease Activity

measured using the clinical Juvenile Arthritis Disease Activity Score (JADAS). Scored on a scale from 0-27, with 0 representing the best possible outcome

Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2

Change in Functional Status

measured using the Childhood Health Assessment Questionnaire (CHAQ). Scored on a scale of 0-3, with 0 representing the best possible outcome.

Time frame: baseline, end of baseline week, end of experimental week 1, end of experimental week 2

Change in Health Related Quality of Life

measured using the Quality of My Life (QoML) questionnaire. This measure is comprised of 2 visual analog scales that measure overall quality of life and health related quality of life. Each scale ranges from 0-10 with 10 representing the best possible outcome.

Data from ClinicalTrials.gov

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