TERMINATED

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

Conditions

Food Neophobia Picky Eating Avoidant Restrictive Food Intake Disorder Anxiety State weighted blanket food avoidance picky eater state anxiety anxiety related to food children

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-01

Study Completion:2024-12-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06420232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Locations (Sites)

Capital Area Speech & Occupational Therapy

Austin, Texas, 78759

United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01

Study Completion Date2024-12-20

Study Record Updates

Study Start Date2024-06-01

Study Completion Date2024-12-20

Terms related to this study

Keywords Provided by Researchers

weighted blanket
food avoidance
picky eater
state anxiety
anxiety related to food
children

Additional Relevant MeSH Terms

Food Neophobia
Picky Eating
Avoidant Restrictive Food Intake Disorder
Anxiety State