The Effect of Preoperative Anxiety on Postoperative Delirium in Children

Overview

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

Full Title of Study: “The Effect of Preoperative Anxiety on Postoperative Delirium in Children Who Will Undergo Circumcision Surgery”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 30, 2019

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • emergence agitation difference between groups
    • Time Frame: 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.
  • effect of parent’s anxiety on child’s anxiety
    • Time Frame: before premedication
    • parent’s anxiety will be evaluated by visual analog scale (VAS) at preoperative holding area

Participating in This Clinical Trial

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

Gender Eligibility: Male

circumcision surgery is applied only to male patients

Minimum Age: 6 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ankara Diskapi Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: ilkay baran akkuş, specialist doctor – Ankara Diskapi Training and Research Hospital
  • Overall Official(s)
    • Ilkay Baran Akkuş, Principal Investigator, Diskapi Yildirim Beyazit Training Education Hospital

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