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NCT03889041 Clinical Trial

Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Quality of Life Clinical Trial

Official title:
Concerns of Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03889041
Other study ID # Dysphagia in esophagealatresia
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date May 1, 2019

Study information
Verified date May 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Children with esophageal atresia and tracheoesophageal fistula (EA-TEF) may experience feeding and swallowing difficulties, which result in stressful interactions between children and caregivers, and potentially impact the concerns of caregivers. The aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.

Description:

Children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF) experience some degrees of feeding and swallowing difficulties Feeding and swallowing difficulties cause aspiration-induced recurrent pneumonia, malnutrition, dehydration and stressful interactions with their caregivers. There is lack of knowledge regarding the concerns of caregivers of children with EA-TEF related to feeding and swallowing disorders.Therefore, the aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Having a child with EA-TEF

- Having a child with swallowing disorders aged between 6 months-18 years

Exclusion Criteria:

- Having a child without swallowing disorders

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Quality of life assessment
The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers

Locations
Country Name City State
Turkey Hacetttepe University Ankara

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Turkish Feeding/Swallowing Impact Survey The Turkish Feeding/Swallowing Impact Survey (T-FS-IS) is used to describe the quality of life related to activities of daily living, worry and feeding difficulty of caregivers of children. It has 18 questions. Daily activities indicate caregivers' perceptions of time demands on daily activities. Worry is the worry of the caregivers about the children's well-being. Feeding difficulty is related to the challenges during delivery of care specific to feeding/swallowing. Each question of the instrument will be answered on a 5-point Likert scale between 1 to 5. A score of '1' indicates never, and a score of '5' indicates almost always. All scores from 18 questions in the T-FS-IS will be summed, and then divided by 18 to calculate an average total score. Scores within each subscale will also be added together, and then divided by the total number of questions in the subscale to calculate an average subscale score. Higher scores from the instrument represent decreased quality of life. 1 month
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