Clinical trial NCT06420232: Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population
Official title: Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Neophobia
Picky Eating
Avoidant Restrictive Food Intake Disorder
Anxiety State
Keywords: weighted blanket
food avoidance
picky eater
state anxiety
anxiety related to food
children
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 12
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: usual care waitlist control period followed by one month intervention
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Food Neophobia Scale for Children (FNSC) questionnaire
timeFrame: Baseline, prior and post treatment, up to 2 months
measure: State-Trait Anxiety Inventory for Children (STAIC)
timeFrame: Baseline, prior and post treatment, up to 2 months
measure: Food Logs
timeFrame: Baseline, prior and post treatment, up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Capital Area Speech & Occupational Therapy
state: Texas
Study officials:
References: