The Effect of Child Choice With Accompanying Parent on Postoperative Delirium During Induction of Anesthesia

Completed

• Conditions: Child Behavior; Postoperative Delirium; Anxiety State

• Registration Number: NCT05931770
• Lead Sponsor: Karaman Training and Research Hospital

Brief Summary

Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs.

The aim of this study will be to evaluate whether the children's or parental preference with attending parent affects on the postoperative delirium of the children or not. The delirium of the children will be assessed by the Pediatric Anesthesia Occurrence Delirium Scale (PAED)

Detailed Description

Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety. Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety and postoperative delirium not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS and postoperative delirium by using PAED.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-25
• Study First Submitted QC: 2023-07-03
• Study Start: 2023-07-04
• Study First Posted: 2023-07-05
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-28
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. 5-12 years aged children
2. ASA physical Status I-II
3. Who underwent day-case surgeries in the Ear Nose and Throat Clinic

Exclusion Criteria

1. Mentally challenged
2. Deaf Child
3. Cerebral Palsy
4. Premedicated Child
5. Language Problem
6. Unco-operative
7. Previous surgery or anesthesia history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room	Postoperative 1st day	Incidence of post-anesthesia and postoperative delirium Discordant behaviors assessed with Pediatric Anesthesia Emergence Delirium Scale (PAED) with five features, each scored using a 5-point Likert scale

Secondary Outcome Measures

Name	Time	Method
Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.	Perioperative period	The mYPAS will be used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 22.9 to 100, with higher scores indicating greater anxiety.

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Turkey