Chronic Pain Clinical Trial
— MOCASOfficial title:
Mechanisms Of Change in Adolescent Pain Self-management
Verified date | September 2022 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The MOCAS Study aims to describe the mechanisms through which sleep deficiency affects youth responses to an online pain self-management intervention over a 6-month period. The study is a single arm trial with repeated measurements using surveys, daily diaries, and actigraphic monitoring.
Status | Completed |
Enrollment | 85 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: - 12-17 years old - Has chronic pain (for at least 3 months) - Has internet access/email address Exclusion Criteria: - Diagnosis of a serious, comorbid health condition (e.g. cancer, arthritis, cystic fibrosis, lupus, etc.) - Parent/adolescent doesn't speak English - Active psychosis/suicidal ideation - Currently taking stimulating medications - Diagnosed sleep disorder (sleep apnea or narcolepsy) - Severe cognitive impairment/unable to read at 5th grade level or complete surveys independently |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity Ratings | Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS) completed by children via daily diary assessments over a 7-day period. Scores range from 0 = no pain to 10 = worst pain imaginable. Scores are averaged at each timeframe with higher scores indicating higher pain intensity. | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | |
Primary | Pain-related Disability | The Child Activity Limitations Interview (CALI-9) is a daily diary validated to assess perceived difficulty in completing 9 daily activities as a measure of pain-related disability. Responses are rated on a 5-point scale (0-4), summed, and transformed to a 0-100 scale, with higher scores indicating greater perceived difficulty with activities. Youth will provide ratings daily for 7 days on their online diaries at each assessment period. Mean total activity limitations across the reporting period is used in analyses, with higher scores indicating greater disability. | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | |
Secondary | Fatigue | Children will complete ratings of fatigue on the PedsQL Multidimensional Fatigue Scale, which yields three scores for general fatigue, cognitive fatigue, and sleep-rest fatigue. Scores range from 0-100, where higher scores indicate fewer problems with fatigue. It has been widely used in many pediatric chronic health conditions demonstrating strong reliability and validity. | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | |
Secondary | Global Health | Global health will be assessed by child self report with the PROMIS pediatric global health scale, a 7-item measure summarizing a child's physical, mental, and social health into a single score. The seven items are rated on a 1-5 scale based on their frequency over the past week. Raw scores are then transformed to a T-Score metric allowing for comparisons to a general (norm) population with mean of 50 and standard deviation of 10. Higher scores mean that the child's global health is more positive. | Baseline, 12 weeks (post-treatment), 6 months (follow-up) | |
Secondary | Number of Treatment Modules Completed | Measured as the number of pain self-management modules completed by each participant during the intervention period ranging from 0 to 8 modules. Module completion was categorized as no exposure with 0 modules completed vs some exposure with 1-8 modules completed. Module usage information is obtained from the administrative database of the internet program and is stored in real time. | 12 weeks (post-treatment) | |
Secondary | Treatment Acceptability | Measured using the Treatment Evaluation Inventory (TEI) completed via teen report, which includes 9 items that are rated on a 5 point likert scale (1-5) where higher scores indicate greater treatment acceptability. Individual scores are summed for a total ranging from 9 to 45, and scores over 37 indicate moderate treatment acceptability. | 12 weeks (post-treatment) |
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