Preoperative AnxietyNCT04009200
The Effect of Preoperative Anxiety on Postoperative Delirium in Children
An observational study of Preoperative Anxiety and Postoperative Delirium, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigation of the effect of preoperative anxiety on postoperative delirium in children who will undergo circumcision operation Read more about this study
- Who is it for?
- Ages 6 to 10 years, men only
- Conditions the study is for
- Preoperative Anxiety, Postoperative Delirium
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 15 Dec 2019
- How long will I take part?
- 1 Day
- 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 10 years
- Men only
- No healthy volunteers
- Child
Study population: First 60 patients coming to the operating room who met the study criteria
Who may be able to join
- ASA 1-2
- Elective circumcision or elective inguinal hernia
Who cannot join
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
- Hearing/ visual impairment
- History of surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training Research Hospital
Ankara, Altındag, 06450
About this study
Official title: The Effect of Preoperative Anxiety on Postoperative Delirium in Children Who Will Undergo Circumcision Surgery
Investigation of the effect of preoperative anxiety on postoperative delirium in children who will undergo circumcision operation
Read the detailed description
In order to determine the effect of circumcision on preoperative anxiety and postoperative delirium, patients will be divided into two groups who will undergo circumcision surgery and who will undergo inguinal hernia surgery.
Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room.
After awakening, patients will be taken to the postoperative wake-up room where Pediatric Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will be recorded. Duration of stay in recovery unit will be recorded
- Conditions
- Preoperative Anxiety, Postoperative Delirium
- Medical subject headings
- Emergence Delirium
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 |
|---|---|---|
| circumcision | Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room. After awakening, patients will be taken to the postoperative wake-up room where Pediatric Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will be recorded. Duration of stay in recovery unit will be recorded | |
| inguinal hernia | Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room. After awakening, patients will be taken to the postoperative wake-up room where Pediatric Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will be recorded. Duration of stay in recovery unit will be recorded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety difference between groups
Preoperative anxiety will be evaluated by mYPAS (modified Yale Preoperative Anxiety Scale). The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization and use of parents). The highest behavioral level observed in each of the five mYPAS categories is the score for that category. Partial weights were calculated and then added to a total score that ranged from 0 to 100. Cut off points were set to classify: a score of 23.4 to 30 for no anxiety, any score greater than 30 for anxiety.
Measured: Before premedication, in operating room
Secondary outcomes (2)
emergence agitation difference between groups
Emergence agitation will be evaluated by PAED scale (pediatric anesthesia emergence delirium). The PAED scale involves five items: eye contact, purposeful actions, awareness of the surroundings, restlessness, inconsolability. First three items are scored as follows: 4= not at all, 3= just a little, 2= quite a bit, 1= very much, 0= extremely. Last two items are scored as follows: 0= not at all, 1= just a little, 2= quite a bit, 3= very much, 4= extremely. The scores of each item will summed to obtain a total score. PAED scale score of 10 or more will be defined as emergence delirium.
Measured: postoperative every 5 minutes during 20 minutes
effect of parent's anxiety on child's anxiety
parent's anxiety will be evaluated by visual analog scale (VAS) at preoperative holding area
Measured: before premedication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Mar 2018
- Primary completion30 Jul 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilkay baran akkuş, Ankara Diskapi Training and Research Hospital
- Investigators
- Ilkay Baran Akkuş, Principal investigator, Diskapi Yildirim Beyazit Training Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009200
- Sponsor's protocol ID
- 44/07
- Status last verified
- Dec 2019
- First submitted
- 27 Jun 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Anxiety on Postoperative Delirium in Children Who Will Undergo Circumcision Surgery
- ClinicalTrials.gov ID
- NCT04009200
- Acronym / sponsor ID
- 44/07
- Conditions
- Preoperative Anxiety, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 5 Jul 2019 (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.
Investigation of the effect of preoperative anxiety on postoperative delirium in children who will undergo circumcision operation
Detailed description
In order to determine the effect of circumcision on preoperative anxiety and postoperative delirium, patients will be divided into two groups who will undergo circumcision surgery and who will undergo inguinal hernia surgery.
Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room.
After awakening, patients will be taken to the postoperative wake-up room where Pediatric Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will be recorded. Duration of stay in recovery unit will be recorded
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| circumcision | – | –Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room. After awakening, patients will be taken to the postoperative wake-up room where Pediatric Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will be recorded. Duration of stay in recovery unit will be recorded |
| inguinal hernia | – | –Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room. After awakening, patients will be taken to the postoperative wake-up room where Pediatric Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will be recorded. Duration of stay in recovery unit will be recorded |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- First 60 patients coming to the operating room who met the study criteria
Key inclusion criteria (2 listed)
- ASA 1-2
- Elective circumcision or elective inguinal hernia
Key exclusion criteria (7 listed)
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
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
Preoperative anxiety difference between groups
Time frame: Before premedication, in operating room
Preoperative anxiety will be evaluated by mYPAS (modified Yale Preoperative Anxiety Scale). The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization and use of parents). The highest behavioral level observed in each of the five mYPAS categories is the score for that category. Partial weights were calculated and then added to a total score that ranged from 0 to 100. Cut off points were set to classify: a score of 23.4 to 30 for no anxiety, any score greater than 30 for anxiety.
2 secondary outcomes
emergence agitation difference between groups
Time frame: postoperative every 5 minutes during 20 minutes
effect of parent's anxiety on child's anxiety
Time frame: before premedication
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 14 Jan 2020.
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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.
Ilkay Baran Akkuş principal investigator
Diskapi Yildirim Beyazit Training Education Hospital
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 Preoperative Anxiety and Postoperative Delirium, run by Ankara Diskapi Training and Research Hospital 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 7 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 14 Jan 2020. 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?
Preoperative anxiety difference between groups (time frame: Before premedication, in operating room). 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 14 Jan 2020.