NCT06420232

Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population

Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Food Neophobia
• Picky Eating
• Avoidant Restrictive Food Intake Disorder
• Anxiety State

Interventions

Type	Name	Description
DEVICE	weighted blanket	Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2024-05-17
• Last updated: 2025-08-05
• Results posted: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study