The Effect of Preoperative Anxiety on Postoperative Delirium in Children

NCT04009200 | Completed

• 1 other identifier: 44/07
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preoperative Anxiety; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• emergence agitation difference between groups

  postoperative every 5 minutes during 20 minutes

• effect of parent's anxiety on child's anxiety

  before premedication

Study Arms (2)

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

Eligibility Criteria

• Age: 6 Years - 10 Years
• Gender Eligibility Details: circumcision surgery is applied only to male patients
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

First 60 patients coming to the operating room who met the study criteria

You may qualify if:

• ASA 1-2
• Elective circumcision or elective inguinal hernia

You may not qualify if:

• Chronic diseases
• Development disability
• Prematurity
• Neurological diseases
• Psychoactive medication use
• Hearing/ visual impairment
• History of surgery

Sponsors & Collaborators

• Ankara Diskapi Training and Research Hospital: lead

Study Sites (1)

Diskapi Yildirim Beyazit Training Research Hospital

Ankara, Altındag, 06450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ilkay Baran Akkuş

  Diskapi Yildirim Beyazit Training Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 5, 2019
• Study Start: March 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 15, 2019
• Last Updated: January 14, 2020

Record last verified: 2019-12

Locations

TU (1)