Anxiety StateNCT02201680
Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation
An observational study of Anxiety State and Parent, run by Istanbul University.
Trial summary
1. Appreciation of preoperative anxiety in children is important for the anesthesiologist. 2. Several factors defined to effect the anxiety levels preoperatively in children such as , age, previous medical encounters , education level and parental anxiety. 3. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Parent, Child
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Sep 2013
- 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: Children planned to undergo surgical procedures or diagnostic procedures under general anesthesia
Who may be able to join
- Legible
Who cannot join
- Illegible due to lack of education or eye diseases
About this study
- Appreciation of preoperative anxiety in children is important for the anesthesiologist.
- Several factors defined to effect the anxiety levels preoperatively in children such as , age, previous medical encounters , education level and parental anxiety. 3. This information was tested for Turkish children during the preoperative anesthetic evaluation.
Read the detailed description
- Before the planned surgery all children accompanying parents filled a questionnaire about the demographics, marital status, economical conditions, education level and other diseases and operations in the family.
- Both the parent and child filled State and Trait Anxiety tests specially prepared for adults Spielberger Anxiety tests and children defined and validation tests had already been proven.
Statistical analysis performed for evaluation.
- Conditions
- Anxiety State, Parent, Child
- Keywords
- anxiety, preoperative
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| parents and children | Anxiety tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
children state anxiety
Anxiety scores were filled within 1 hour no further evalution was performed.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJun 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. A. Pervin SUTAS BOZKURT, Istanbul University
- Investigators
- Rovnat Babazade, M.D., Principal investigator, Istanbul University Cerrahpaşa Medical FacultyLevent Kayaalp, Prof. Dr., Principal investigator, Private PracticeGurcan Gungor, M.D., Principal investigator, Istanbul UniversityBurak Dogangun, Asoc. Prof, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201680
- Sponsor's protocol ID
- 15112005
- Other IDs
- 31130
- Status last verified
- Jul 2014
- First submitted
- 12 Jul 2014
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation
- ClinicalTrials.gov ID
- NCT02201680
- Acronym / sponsor ID
- 15112005
- Conditions
- Anxiety State, Parent, Child
- Keywords
- anxiety, preoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Jul 2014 (estimated)
- 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.
- Appreciation of preoperative anxiety in children is important for the anesthesiologist.
- Several factors defined to effect the anxiety levels preoperatively in children such as , age, previous medical encounters , education level and parental anxiety. 3. This information was tested for Turkish children during the preoperative anesthetic evaluation.
Detailed description
- Before the planned surgery all children accompanying parents filled a questionnaire about the demographics, marital status, economical conditions, education level and other diseases and operations in the family.
- Both the parent and child filled State and Trait Anxiety tests specially prepared for adults Spielberger Anxiety tests and children defined and validation tests had already been proven.
Statistical analysis performed for evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parents and children | – | –Anxiety tests |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children planned to undergo surgical procedures or diagnostic procedures under general anesthesia
Key inclusion criteria (1 listed)
- Legible
Key exclusion criteria (1 listed)
- Illegible due to lack of education or eye diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
children state anxiety
Time frame: 1 hour
Anxiety scores were filled within 1 hour no further evalution was performed.
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 28 Jul 2014.
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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.
Rovnat Babazade, M.D. principal investigator
Istanbul University Cerrahpaşa Medical Faculty
Levent Kayaalp, Prof. Dr. principal investigator
Private Practice
Gurcan Gungor, M.D. principal investigator
Istanbul University
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety State and Parent, run by Istanbul University.
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: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
children state anxiety (time frame: 1 hour). 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 28 Jul 2014.