Concussion Goody Bag Study

NCT07884604 — Withdrawn, Ann & Robert H Lurie Children's Hospital of Chicago

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Evaluation of Low-Level Activity Intervention in Pediatric Concussion Patients

RegistryNCT07884604
StatusWithdrawn - Poor feasibility of project recruitment and execution
Study typeObservational
SponsorAnn & Robert H Lurie Children's Hospital of Chicago (Other)
ConditionsSports Related Concussion
Datesstart 2015-10-01, primary completion 2019-05-01 (estimated), completion 2019-12-01 (estimated), first posted 2026-10-20, last updated 2026-10-20
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Sports Related Concussion

-Summary

For the pilot study, thirty eligible participants will be provided a concussion goody bag at their initial concussion evaluation visit. Each goody bag consists of 12 items, with a letter briefly describing the intended purpose for each item. Each participant will listen to a scripted tutorial by the research personnel, explaining the goody bag and why they are receiving it. Per standard of care, participants will return to clinic within 1-2 weeks for a follow up visit, at which time, they will complete a short questionnaire to assess overall usefulness of the bag, as well as individual rankings on how often they used each specific item. If the participant did not use any items, they will complete an additional question, describing why that item was not used, for each unused item. Also, the participants will be asked if they felt any additional items would have been helpful to them. Investigators expect these questionnaires to provide valuable insight from our patient perspectives about post-concussion care.

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+Outcome measures

Primary outcomes

  • Evaluation of participant opinions on the usefulness of a concussion goody bag. [3 weeks]: Participants will be provided a concussion goody bag at their initial concussion evaluation visit. At a participant's return visit to clinic, they are surveyed on the overall usefulness of the goody-bag and it's contents. The survey utilizes a subjective scale. The scale of usefulness is measured from \[1-5\] with 1 being "Not Helpful" and 5 being "Very Helpful"

+Eligibility

Sex: All, ages: 6 Years to 17 Years

Inclusion Criteria:

* has a sports related concussion
* between the ages of 6-17 years
* is presenting to our clinic within three weeks of the concussion

Exclusion Criteria:

* has a history of prior diagnosed concussion
* has a history of headache (migraine or non-migraine)
* has a history of learning disability
* has Attention Deficit Disorder (ADD)
* has a history of anxiety, depression, or bipolar mood disorder
* is non-English speaking

+Locations (1)

FacilityCityCountryStatus
Ann and Robert H. Lurie Children's HospitalChicago, IllinoisUnited States