Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease
February 21, 2024 updated by: Busra Tetik Dincer, Sisli Hamidiye Etfal Training and Research Hospital
Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease: Prospective Controlled Trial
Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways.
Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD.
Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ).
The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives.
The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
159
Phase
- Not Applicable
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
-
-
-
Istanbul, Turkey
- Şişli Hamidiye Etfal Research and Training Hospital
-
-
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
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged between 8-17 years
- Diagnosed Inflammatory bowel disease
- Healthy adolescents aged between 8-17 years
Exclusion Criteria:
- Not obtaining informed consent
- Diagnosis of psychiatric disorder
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
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inflammatory bowel disease group
Adolescents with Inflammatory bowel diseases will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ).
|
Questionnaire
Questionnaire
|
|
Active Comparator: Control group
Adolescents without known diseases in same age group will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ) as control group
|
Questionnaire
Questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL) score
Time Frame: 1 day after questionnaire
|
Score of questionnaire
|
1 day after questionnaire
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 1 day after questionnaire
|
Score of questionnaire
|
1 day after questionnaire
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Nafiye Urgancı, M.D., Sisli Hamidiye Etfal Training and Research Hospital, Division of pediatric gastroenterology
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)
February 14, 2024
Primary Completion (Actual)
February 20, 2024
Study Completion (Actual)
February 21, 2024
Study Registration Dates
First Submitted
February 13, 2024
First Submitted That Met QC Criteria
February 13, 2024
First Posted (Actual)
February 21, 2024
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30.01.2024-4272
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.