Inflammatory Bowel DiseasesNCT06270277
Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease
A study testing Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ) in people with Inflammatory Bowel Diseases and Psychosocial Impairment, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Psychosocial Impairment
- What is being tested?
- Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2024to 21 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 8-17 years
- Diagnosed Inflammatory bowel disease
- Healthy adolescents aged between 8-17 years
Who cannot join
- Not obtaining informed consent
- Diagnosis of psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Research and Training Hospital
Istanbul
About this study
Official title: 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.
- Being tested
- Pediatric Quality of Life Inventory (PedsQL), Strengths and Difficulties Questionnaire (SDQ)
- Keywords
- Inflammatory bowel diseases, Psychosocial condition, Crohn's disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Quality of Life Inventory (PedsQL)Diagnostic test
Questionnaire
Strengths and Difficulties Questionnaire (SDQ)Diagnostic test
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Diagnostic Test: Pediatric Quality of Life Inventory (PedsQL); Diagnostic Test: Strengths and Difficulties Questionnaire (SDQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Quality of Life Inventory (PedsQL) score
Score of questionnaire
Measured: 1 day after questionnaire
Strengths and Difficulties Questionnaire (SDQ)
Score of questionnaire
Measured: 1 day after questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start14 Feb 2024
- Primary completion20 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Tetik Dincer, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Nafiye Urgancı, M.D., Study director, Sisli Hamidiye Etfal Training and Research Hospital, Division of pediatric gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270277
- Sponsor's protocol ID
- 30.01.2024-4272
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease: Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT06270277
- Acronym / sponsor ID
- 30.01.2024-4272
- Keywords
- Inflammatory bowel diseases, Psychosocial condition, Crohn's disease, Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease group | Experimental | Diagnostic Test: Pediatric Quality of Life Inventory (PedsQL), Diagnostic Test: Strengths and Difficulties Questionnaire (SDQ)Adolescents with Inflammatory bowel diseases will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). |
| Control group | Active comparator | Diagnostic Test: Pediatric Quality of Life Inventory (PedsQL), Diagnostic Test: Strengths and Difficulties Questionnaire (SDQ)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 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged between 8-17 years
- Diagnosed Inflammatory bowel disease
- Healthy adolescents aged between 8-17 years
Key exclusion criteria (2 listed)
- Not obtaining informed consent
- Diagnosis of psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Quality of Life Inventory (PedsQL)Questionnaire | Diagnostic test | Control group, Inflammatory bowel disease group |
| Strengths and Difficulties Questionnaire (SDQ)Questionnaire | Diagnostic test | Control group, Inflammatory bowel disease group |
Primary outcome
Pediatric Quality of Life Inventory (PedsQL) score
Time frame: 1 day after questionnaire
Score of questionnaire
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 1 day after questionnaire
Score of questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nafiye Urgancı, M.D. study director
Sisli Hamidiye Etfal Training and Research Hospital, Division of pediatric gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ) in people with Inflammatory Bowel Diseases and Psychosocial Impairment, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory (PedsQL) score (time frame: 1 day after questionnaire). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.