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NCT06270277 Clinical Trial

Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:
Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease: Prospective Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06270277
Other study ID # 30.01.2024-4272
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2024
Est. completion date February 21, 2024

Study information
Verified date February 2024
Source Sisli Hamidiye Etfal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 159
Est. completion date February 21, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Pediatric Quality of Life Inventory (PedsQL)
Questionnaire
• Strengths and Difficulties Questionnaire (SDQ)
Questionnaire

Locations
Country Name City State
Turkey Sisli Hamidiye Etfal Research and Training Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pediatric Quality of Life Inventory (PedsQL) score Score of questionnaire 1 day after questionnaire
Primary Strengths and Difficulties Questionnaire (SDQ) Score of questionnaire 1 day after questionnaire
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