The Effect of Screen Time on Recovery From Concussion

Study Overview
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Brief Summary
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This study will prospectively examine the effect of screen time on recovery from concussion. Patients 12 to 25 years of age presenting to the ED with a concussion will be randomized to allow for screen time as tolerated or to abstain from screen time for the first 48 hours of recovery. The amount of screen time use and duration of concussive symptoms will be assessed through daily surveys and a daily post-concussive symptom score (PCSS).

Official Title
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The Effect of Screen Time on Recovery From Concussion

Conditions
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Concussion, Brain

Intervention / Treatment
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* Behavioral: Screen time permitted
* Behavioral: Screen Time Abstain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals presenting to the emergency department with a traumatic head injury sustained in the last 24 hours and diagnosed concussion as defined by Acute Concussion Evaluation tool (ACE-ED) Between 12 and 25.99 years of age English-speaking Subject (and parent/guardian when applicable) is able and willing to provide informed consent and assent pregnant women, Exclusion Criteria: individuals who have a Glasgow Coma Scale score of 13 or less; have brain abnormalities on imaging; have severe preexisting neurological conditions; a concussion diagnosed within the last 2 weeks; have significant developmental delay; are intoxicated; require neurosurgical intervention, intubation, or hospital admission individuals who do not meet the age criteria; non-English speaking; prisoners; unable or unwilling to provide informed consent; Are under the age of 18 and do not have a parent/guardian with them who is willing and able to consent.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Screen time permitted<br>Concussion sufferers permitted screen time for first 48 hours of recovery | Behavioral: Screen time permitted<br>* Cohort will not be directed to abstain from screen time<br>|
| Active Comparator: Screen time abstain<br>Concussion sufferers asked to abstain from screen time for first 48 hours of recovery | Behavioral: Screen Time Abstain<br>* Cohort will be directed to abstain from screen time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of concussive symptoms | The average number of days from initial concussion diagnosis until participant has a Post Concussive Symptom Scale Score (PCSS) of less than 7 | From date of randomization until PCSS of less than 7 is achieved or up to 10 days, whichever comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of specific symptoms (Day 1-3) | The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant. | Day 1 to day 3 | 
| Number of specific symptoms each day (Day 4-10) | The average total number of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant. | Day 4 to day 10 | 
| Severity of specific symptoms (Day 1-3) | The average severity of symptoms as reported on the Post Concussive Symptom Scale (PCSS) by participant. | Day 1 to day 3 | 
| Severity of specific symptoms (Day 4-10) | The average severity of symptoms as reported daily by participant on the Post Concussive Symptom Scale (PCSS) by participant. | Day 4 to day 10 | 
| Amount of screen time use | Average minutes of screen time (video games, television, computer, smartphone) as self-reported by participant on questionnaire. | Randomization to 48 hours. | 
| Days until return to school/work and sports | The average number of days until the participant is able to return to routine activities such as school/work and sports as self-reported on questionnaire. | From date of randomization to return to school/work and sports, up to day 10. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screen time