Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT03889041

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

64.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia Quality of Life	Other: Quality of life assessment

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 Design

Study Type:

Observational

Actual Enrollment :

64 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Concerns of Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Caregivers of children with EA-TEF Caregivers of children with esophageal atresia and tracheoesophageal fistula will be included in the study.	Other: Quality of life assessment The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers

Arm

Intervention/Treatment

Caregivers of children with EA-TEF

Caregivers of children with esophageal atresia and tracheoesophageal fistula will be included in the study.

Other: Quality of life assessment

The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacetttepe University	Ankara		Turkey	06100

Sponsors and Collaborators

Hacettepe University

Investigators

Principal Investigator: SELEN S ARSLAN, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SELEN SEREL ARSLAN, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT03889041

Other Study ID Numbers:

Dysphagia in esophagealatresia

First Posted:

Mar 25, 2019

Last Update Posted:

May 10, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Esophageal Atresia

Tracheoesophageal Fistula

Fistula

Study Results

No Results Posted as of May 10, 2019