Evaluation of Depression and Anxiety Levels of Parents of Children with Spina Bifida

January 26, 2025 updated by: Marmara University
Studies in the literature have measured the anxiety and depression levels of parents of children with spina bifida. Additionally, it has been reported that parents of children with non-neurogenic lower urinary tract dysfunction, such as nocturnal enuresis and overactive bladder, have increased levels of anxiety and depression. In this study, the investigators aim to evaluate, for the first time, the effect of urinary system symptoms and findings in children with spina bifida on the anxiety and depression levels of their parents.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Between January 2024 and December 2024, the demographic data of patients with spina bifida under follow-up, as well as the results of dimercaptosuccinic acid (DMSA) static renal scintigraphy, urinary ultrasonography (USG), and voiding cystourethrography (VCUG), which indicate upper urinary tract (UUT) damage, were recorded. Symptom scoring was performed on the primary caregiver of the child, and anxiety and depression scores were calculated. The Hospital Anxiety and Depression Scale (HADS) and the Beck Anxiety Inventory were used to assess these symptoms in the parents. The presence of renal scarring, hydronephrosis, or vesicoureteral reflux (VUR) in the DMSA was considered as UUT damage. Patients were divided into subgroups based on demographic data, UUT damage, history of febrile urinary tract infections (UTIs), incontinence, and the presence of motor deficits. These groups were then compared in terms of anxiety and depression scores.

Study Type

Observational

Enrollment (Actual)

50

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

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University School of Medicine Urology Department

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Parents whom have a child with spina bifida

Description

Inclusion Criteria:

- Having a child with spina bifida

Exclusion Criteria:

- Diagnosis of psychiatric illness

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spina Bifida Group
Parents ( mother or father) have child with spina bifida
Diagnostic test: Anxiety, Depression levels
Parents of children with spina bifida will be filled out symptom scores regarding depression and anxiety levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level- Hospital Anxiety Scale
Time Frame: Baseline

For Anxiety Hospital Anxiety scale used

In the Hospital Anxiety Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of anxiety.
Baseline
Depression Level
Time Frame: Baseline

For Depression Hospital Depression scale used

In the Hospital Depression Score, the minimum score is 0, and the maximum score is 21. As the score increases, it indicates higher levels of depression.
Baseline
Anxiety Level- BECK Scale
Time Frame: Baseline
In the BECK Scale, the minimum score is 0, and the maximum score is 63. As the score increases, it indicates higher levels of pain.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: CAGRI A. SEKERCİ, MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

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)

January 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR.UAD.0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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