Spina BifidaNCT06802770
Evaluation of Depression and Anxiety Levels of Parents of Children with Spina Bifida
An observational study of Spina Bifida, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Anxiety, Depression levels
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents whom have a child with spina bifida
Who may be able to join
- Having a child with spina bifida
Who cannot join
- Diagnosis of psychiatric illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Istanbul, 34854
About this study
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.
Read the 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.
- Conditions
- Spina Bifida
- Being tested
- Anxiety, Depression levels
- Keywords
- spina bifida, anxiety, depression
- Medical subject headings
- Spinal Dysraphism, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety, Depression levelsDiagnostic test
Parents of children with spina bifida will be filled out symptom scores regarding depression and anxiety levels.
| Study group | Role | What they receive |
|---|---|---|
| Spina Bifida Group | Parents ( mother or father) have child with spina bifida Receives: Diagnostic Test: Anxiety, Depression levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAGRI A. SEKERCİ, Study director, MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802770
- Sponsor's protocol ID
- MAR.UAD.0013
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Altuntas T, Imanli E, Ulker ND, Ozkan OC, Sekerci CA, Cam K, Tarcan T, Yucel S. Urinary Incontinence and Psychological Distress Among Parents of Children With Spina Bifida. Neurourol Urodyn. 2026 Apr;45(4):794-801. doi: 10.1002/nau.70271. Epub 2026 Mar 18.
PubMed 41847996
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Depression and Anxiety Levels of Parents of Children with Spina Bifida
- ClinicalTrials.gov ID
- NCT06802770
- Acronym / sponsor ID
- MAR.UAD.0013
- Conditions
- Spina Bifida
- Keywords
- spina bifida, anxiety, depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spina Bifida Group | – | Diagnostic Test: Anxiety, Depression levelsParents ( mother or father) have child with spina bifida |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents whom have a child with spina bifida
Key inclusion criteria (1 listed)
- Having a child with spina bifida
Key exclusion criteria (1 listed)
- Diagnosis of psychiatric illness
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 |
|---|---|---|
| Anxiety, Depression levelsParents of children with spina bifida will be filled out symptom scores regarding depression and anxiety levels. | Diagnostic test | Spina Bifida Group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 41847996Altuntas T, Imanli E, Ulker ND, Ozkan OC, Sekerci CA, Cam K, Tarcan T, Yucel S. Urinary Incontinence and Psychological Distress Among Parents of Children With Spina Bifida. Neurourol Urodyn. 2026 Apr;45(4):794-801. doi: 10.1002/nau.70271. Epub 2026 Mar 18.
- Individual participant dataSharing planned: Undecided
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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.
CAGRI A. SEKERCİ study director
MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida, run by Marmara University 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Anxiety Level- Hospital Anxiety Scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802770, which also lists 1 linked publication.
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 31 Jan 2025.