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

The Effect of Child Choice With Accompanying Parent on Pediatric Anxiety and Postoperative Delirium During Induction of Anesthesia During Day Case Surgeries.

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)

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Child Behavior; Anxiety State
• Intervention / Treatment: Procedure: Selection of parent(mother or father) according to children preference; Procedure: Parent (mother or father) selection according to parents' preference

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

• Study Contact: Name: Fatih Yücedağ, Asist Prof; Phone Number: 3246 0 338 226 30 00; Email: drfatihyucedag@gmail.com
• Study Contact Backup: Name: Fatih Yücedağ, Assist Prof

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Training and Research Hospital
    • Contact: Fatih Yucedag, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study included 80 children of both genders, aged 5-12 years, who underwent day-case surgeries in the Ear Nose and Throat Clinic with ASA physical Status I-II will be enrolled

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group Child Preference; The children will prefer parents (mother or father) who will accompany them in the preoperative holding area and at induction	Procedure: Selection of parent(mother or father) according to children preference; The parent who will accompany the child during the perioperative period will be determined by the child. will be determined by children preference
Group Parent's Preference; Parents will decide among themselves and prefer the parents (mother or father) who will accompany them from the side of the parent, in the pre-operative waiting area and during induction.	Procedure: Parent (mother or father) selection according to parents' preference; Accompanying parentwho will accompany during the perioperative period will be determined by the parents. to be determined by

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room	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	Postoperative 1st day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.	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.	Perioperative period

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Fatih Yücedağ, Assist Prof, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Delirium; day- case surgery, anxiety children
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Anxiety Disorders; Emergence Delirium
• Other Study ID Numbers: 06-2023/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No