Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

May 8, 2019 updated by: SELEN SEREL ARSLAN, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacetttepe University

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.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Caregivers of children with EA-TEF

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Turkish Feeding/Swallowing Impact Survey
Time Frame: 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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: SELEN S ARSLAN, Hacettepe University

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 Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dysphagia in esophagealatresia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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