The Effect of Preoperative Anxiety on Postoperative Delirium in Children

Postoperative Delirium Clinical Trial

Official title:

The Effect of Preoperative Anxiety on Postoperative Delirium in Children Who Will Undergo Circumcision Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009200
• Other study ID #: 44/07
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2019
• Source: Ankara Diskapi Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Investigation of the effect of preoperative anxiety on postoperative delirium in children who will undergo circumcision operation

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• ASA 1-2

• Elective circumcision or elective inguinal hernia

Exclusion Criteria:

• Chronic diseases

• Development disability

• Prematurity

• Neurological diseases

• Psychoactive medication use

• Hearing/ visual impairment

• History of surgery

Related Conditions & MeSH terms

• Anxiety Disorders
• Delirium
• Postoperative Delirium
• Preoperative Anxiety

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before premedication, in operating room
Secondary	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.	postoperative every 5 minutes during 20 minutes
Secondary	effect of parent's anxiety on child's anxiety	parent's anxiety will be evaluated by visual analog scale (VAS) at preoperative holding area	before premedication