The Effect of Screen Time on Recovery From Concussion

NCT ID: NCT03564210

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2020-04-01

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).

Detailed Description

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Conditions

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Concussion, Brain

Keywords

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screen time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Screen time permitted

Concussion sufferers permitted screen time for first 48 hours of recovery

Group Type ACTIVE_COMPARATOR

Screen time permitted

Intervention Type BEHAVIORAL

Cohort will not be directed to abstain from screen time

Screen time abstain

Concussion sufferers asked to abstain from screen time for first 48 hours of recovery

Group Type ACTIVE_COMPARATOR

Screen Time Abstain

Intervention Type BEHAVIORAL

Cohort will be directed to abstain from screen time

Interventions

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Screen time permitted

Cohort will not be directed to abstain from screen time

Intervention Type BEHAVIORAL

Screen Time Abstain

Cohort will be directed to abstain from screen time

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theodore Macnow

OTHER

Sponsor Role lead

Responsible Party

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Theodore Macnow

Assistant professor of pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Theodore Macnow, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Memorial Health

Locations

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UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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Macnow T, Curran T, Tolliday C, Martin K, McCarthy M, Ayturk D, Babu KM, Mannix R. Effect of Screen Time on Recovery From Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2021 Nov 1;175(11):1124-1131. doi: 10.1001/jamapediatrics.2021.2782.

Reference Type DERIVED
PMID: 34491285 (View on PubMed)

Other Identifiers

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H00014355

Identifier Type: -

Identifier Source: org_study_id