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

NCT06802770 | Active Not Recruiting

• 1 other identifier: MAR.UAD.0013
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spina Bifida

Keywords

spina bifida; anxiety; depression

Outcome Measures

Primary Outcomes (3)

• Anxiety Level- Hospital Anxiety Scale

  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

  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

  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

Study Arms (1)

Spina Bifida Group

Parents ( mother or father) have child with spina bifida

Diagnostic Test: Anxiety, Depression levels

Interventions

Anxiety, Depression levels DIAGNOSTIC_TEST

Parents of children with spina bifida will be filled out symptom scores regarding depression and anxiety levels.

Spina Bifida Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents whom have a child with spina bifida

You may qualify if:

• \- Having a child with spina bifida

You may not qualify if:

• \- Diagnosis of psychiatric illness

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Dysraphism; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• CAGRI A. SEKERCİ

  MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 31, 2025
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: January 30, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

TU (1)