The Effect of Preoperative Anxiety on Postoperative Delirium in Children

Completed

• Conditions: Postoperative Delirium; Preoperative Anxiety

• Registration Number: NCT04009200
• Lead Sponsor: Ankara Diskapi Training and Research Hospital

Brief Summary

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 Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Primary Completion: 2019-07-30
• Status Verified: 2019-12
• Study Completion: 2019-12-15
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety difference between groups	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.

Secondary Outcome Measures

Name	Time	Method
effect of parent's anxiety on child's anxiety	before premedication	parent's anxiety will be evaluated by visual analog scale (VAS) at preoperative holding area
emergence agitation difference between groups	postoperative every 5 minutes during 20 minutes	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.

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Training Research Hospital; 🇹🇷 Ankara, Altındag, Turkey