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Clinical Trials/NCT05931770
NCT05931770
Completed
Not Applicable

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

Karaman Training and Research Hospital1 site in 1 country80 target enrollmentJuly 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety State
Sponsor
Karaman Training and Research Hospital
Enrollment
80
Locations
1
Primary Endpoint
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 4, 2023
End Date
September 28, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Karaman Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Mentally challenged
  • Cerebral Palsy
  • Premedicated Child
  • Language Problem
  • Unco-operative
  • Previous surgery or anesthesia history

Outcomes

Primary Outcomes

Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room

Time Frame: 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 Outcomes

  • Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.(Perioperative period)

Study Sites (1)

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