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

NCT06270277 | Completed

• 1 other identifier: 30.01.2024-4272
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Psychosocial Impairment

Keywords

Inflammatory bowel diseases; Psychosocial condition; Crohn's disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (2)

• Pediatric Quality of Life Inventory (PedsQL) score

  Score of questionnaire

  1 day after questionnaire

• Strengths and Difficulties Questionnaire (SDQ)

  Score of questionnaire

  1 day after questionnaire

Study Arms (2)

Inflammatory bowel disease group

EXPERIMENTAL

Adolescents with Inflammatory bowel diseases will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ).

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

Control group

ACTIVE COMPARATOR

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

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

Interventions

Pediatric Quality of Life Inventory (PedsQL) DIAGNOSTIC_TEST

Questionnaire

Control group; Inflammatory bowel disease group

Strengths and Difficulties Questionnaire (SDQ) DIAGNOSTIC_TEST

Questionnaire

Control group; Inflammatory bowel disease group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 8-17 years
• Diagnosed Inflammatory bowel disease
• Healthy adolescents aged between 8-17 years

You may not qualify if:

• Not obtaining informed consent
• Diagnosis of psychiatric disorder

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Nafiye Urgancı, M.D.

  Sisli Hamidiye Etfal Training and Research Hospital, Division of pediatric gastroenterology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Adolescents with Inflammatory bowel diseases and healthy control group in same age will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ).

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 14, 2024
• Primary Completion: February 20, 2024
• Study Completion: February 21, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)