Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Completed

• Conditions: Quality of Life; Dysphagia
• Interventions: Other: Quality of life assessment

• Registration Number: NCT03889041
• Lead Sponsor: Hacettepe University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Study Start: 2019-04-01
• Status Verified: 2019-05
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caregivers of children with EA-TEF	Quality of life assessment	Caregivers of children with esophageal atresia and tracheoesophageal fistula will be included in the study.

Primary Outcome Measures

Name	Time	Method
The Turkish Feeding/Swallowing Impact Survey	1 month	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.

Trial Locations

Locations (1)

Hacetttepe University; 🇹🇷 Ankara, Turkey