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

NCT ID: NCT06270277

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2024-02-21

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases Psychosocial Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Inflammatory bowel disease group

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

Group Type EXPERIMENTAL

Pediatric Quality of Life Inventory (PedsQL)

Intervention Type DIAGNOSTIC_TEST

Questionnaire

Strengths and Difficulties Questionnaire (SDQ)

Intervention Type DIAGNOSTIC_TEST

Questionnaire

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

Group Type ACTIVE_COMPARATOR

Pediatric Quality of Life Inventory (PedsQL)

Intervention Type DIAGNOSTIC_TEST

Questionnaire

Strengths and Difficulties Questionnaire (SDQ)

Intervention Type DIAGNOSTIC_TEST

Questionnaire

Interventions

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Pediatric Quality of Life Inventory (PedsQL)

Questionnaire

Intervention Type DIAGNOSTIC_TEST

Strengths and Difficulties Questionnaire (SDQ)

Questionnaire

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Busra Tetik Dincer

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nafiye Urgancı, M.D.

Role: STUDY_DIRECTOR

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

Locations

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Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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30.01.2024-4272

Identifier Type: -

Identifier Source: org_study_id

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