Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-03 @ 5:45 AM
Study NCT ID:
NCT06420232
Status:
TERMINATED
Last Update Posted:
2025-08-05
First Post:
2024-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
challenges with recruitment and attrition, and PI graduated from UTMB PPOTD program
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Food Anxiety
Brief Summary:
This small experimental pilot study addresses the knowledge gap related to the use of weighted blankets for children with anxiety related to food and eating.
Detailed Description:
The purpose of the study is to research if weighted blankets might help children with anxiety related to food tolerate new foods better. The parent will be asked to complete a 10-question questionnaire and make a list of the foods the child eats on three occasions (before the study begins, after a control period and after the child uses the weighted blanket). The child will be asked to use a weighted blanket for 5 to 15 minutes prior to at least 3 meals a week for one month, and the child will be asked to complete a 20-question questionnaire taking about 5-12 minutes to complete asking about how they feel on days that they use the weighted blanket and one time a week during the month that they don't use the weighted blanket. The parent will be asked to report any new foods the child tries on the days that they do use the weighted blanket. The parent will be asked to keep the weighted blanket and supervise all use of the weighted blanket for safety. This study will take approximately 2 months total.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: