Psychogenic CoughNCT03721224
Psychiatric Disorders in Children With Psychogenic Cough
An observational study of Psychogenic Cough, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to evaluate psychiatric disorders and clinical features of children with psychogenic cough. Psychiatric disorders are assessed via a semi-structured interview (Kiddie Schedule for Affective Disorders and Schizophrenia) and clinical features are investigated via sociodemographic form, which was… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychogenic Cough
- What is being tested?
- Kiddie Schedule for Affective Disorders and Schizophrenia
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Jan 2019
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients who were diagnosed as having psychogenic cough between 2015 and 2018 years. Age and gender matched control who don't have any chronical health problems.
Who may be able to join
- Having psychogenic cough for study group.
- Referred to pediatric clinics.
Who cannot join
- Chronical psychiatric disorder and pediatric disease history for control group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychiatric Disorders and Clinical Features of Children With Psychogenic Cough
The study aims to evaluate psychiatric disorders and clinical features of children with psychogenic cough. Psychiatric disorders are assessed via a semi-structured interview (Kiddie Schedule for Affective Disorders and Schizophrenia) and clinical features are investigated via sociodemographic form, which was developped by researchers. Investigator planned to compare psychiatric diagnoses, specifically anxiety and depression, with children referred to pediatric clinics.
- Conditions
- Psychogenic Cough
- Being tested
- Kiddie Schedule for Affective Disorders and Schizophrenia
- Keywords
- psychiatry, children, habit cough
- Medical subject headings
- somatic cough syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiddie Schedule for Affective Disorders and SchizophreniaDiagnostic test
Both of the clinical and control group will be evaluated via Psychiatric semi-structured interview
| Study group | Role | What they receive |
|---|---|---|
| Children with psychogenic cough | children who were examined by Pediatric Respiratory Disease specialist and diagnosed as having a psychogenic cough. Receives: Diagnostic Test: Kiddie Schedule for Affective Disorders and Schizophrenia | |
| control subjects | children who were referred to pediatrics clinics and do not have a chronical disease. Receives: Diagnostic Test: Kiddie Schedule for Affective Disorders and Schizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric disorders
Total rate of psychiatric disorders, specifically internalizing disorders, identified via semi-structured diagnostic interview
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Sep 2018
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychogenic CoughStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahman Cahid Örengül, Bezmialem Vakif University
- Investigators
- Abdurrahman Cahid Orengul, Study director, Bezmialem University Department of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721224
- Sponsor's protocol ID
- BVU Psychogenic cough study 1
- Status last verified
- Jul 2019
- First submitted
- 22 Oct 2018
- Last updated
- 19 Jul 2019
- 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 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Disorders and Clinical Features of Children With Psychogenic Cough
- ClinicalTrials.gov ID
- NCT03721224
- Acronym / sponsor ID
- BVU Psychogenic cough study 1
- Conditions
- Psychogenic Cough
- Keywords
- psychiatry, children, habit cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 26 Oct 2018 (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.
The study aims to evaluate psychiatric disorders and clinical features of children with psychogenic cough. Psychiatric disorders are assessed via a semi-structured interview (Kiddie Schedule for Affective Disorders and Schizophrenia) and clinical features are investigated via sociodemographic form, which was developped by researchers. Investigator planned to compare psychiatric diagnoses, specifically anxiety and depression, with children referred to pediatric clinics.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with psychogenic cough | – | Diagnostic Test: Kiddie Schedule for Affective Disorders and Schizophreniachildren who were examined by Pediatric Respiratory Disease specialist and diagnosed as having a psychogenic cough. |
| control subjects | – | Diagnostic Test: Kiddie Schedule for Affective Disorders and Schizophreniachildren who were referred to pediatrics clinics and do not have a chronical disease. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients who were diagnosed as having psychogenic cough between 2015 and 2018 years. Age and gender matched control who don't have any chronical health problems.
Key inclusion criteria (2 listed)
- Having psychogenic cough for study group.
- Referred to pediatric clinics.
Key exclusion criteria (1 listed)
- Chronical psychiatric disorder and pediatric disease history for control group.
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 |
|---|---|---|
| Kiddie Schedule for Affective Disorders and SchizophreniaBoth of the clinical and control group will be evaluated via Psychiatric semi-structured interview | Diagnostic test | Children with psychogenic cough, control subjects |
Primary outcome
Psychiatric disorders
Time frame: Baseline
Total rate of psychiatric disorders, specifically internalizing disorders, identified via semi-structured diagnostic interview
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 19 Jul 2019.
- Individual participant dataSharing planned: No
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.
Abdurrahman Cahid Orengul study director
Bezmialem University Department of Child and Adolescent Psychiatry
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 Psychogenic Cough, run by Bezmialem Vakif 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 2 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: finished, as of the sponsor's last update on 19 Jul 2019. 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?
Psychiatric disorders (time frame: Baseline). 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 19 Jul 2019.