Using weighted blankets to help children with food-related anxiety
Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population
This study is testing if using weighted blankets can help children aged 8-12 feel less anxious about food and try new things to eat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT06420232 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of weighted blankets in helping children aged 8-12 who experience anxiety related to food. Parents will complete questionnaires and track their child's food intake before and after using the weighted blanket during meals. The child will use the blanket for 5 to 15 minutes prior to at least three meals each week for one month. The study aims to determine if this intervention can improve the child's tolerance for new foods and reduce anxiety around eating.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-12 who have identified feeding challenges and anxiety related to food.
Not a fit: Patients with medical conditions that contraindicate the use of a weighted blanket or those outside the age range of 8-12 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help children with food-related anxiety expand their diets and improve their overall eating habits.
How similar studies have performed: While the use of weighted blankets for anxiety is gaining interest, this specific application for food-related anxiety in children is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject and guardian has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures. 2. Subject has identified feeding challenges 3. Subject has anxiety related to food as reported by caregiver 4. Subject is between the ages of 8-12 5. Subject has good reading abilities 6. Subject weighs 30 pounds or more Exclusion Criteria: 1. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation due to the inability to remove the blanket safely. Examples of diagnoses that would exclude a participant include spinal cord injury, cerebral palsy, and muscular dystrophy. 2. Concurrent participation on another research study 3. Participants outside of the ages 8-12 4. Participants refuse to use the weighted blanket 5. If the use of a weighted blanket is contraindicated for any reason 6. Participants lacking the reading ability to complete a questionnaire 7. Participants who weigh under 30 pounds per parent report and cannot use a commercially available weighted blanket as the minimum weight of a weighted blanket is 3 pounds will be excluded but this exclusion is unlikely due to the inclusion age range
Where this trial is running
Austin, Texas
- Capital Area Speech & Occupational Therapy — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Claudia A Hilton, PhD
- Email: clhilton@utmb.edu
- Phone: 3143415161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.