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

NCT ID: NCT06420232

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-20

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Weighted Blanket

Group Type: EXPERIMENTAL

weighted blanket

Intervention Type: DEVICE

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

Interventions

weighted blanket

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Capital Area Speech & Occupational Therapy

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

23-0342

Identifier Type: -

Identifier Source: org_study_id