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

NCT05931770 | Completed DMC

• 1 other identifier: 06-2023/11
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Anxiety State; Child Behavior; Postoperative Delirium

Keywords

day- case surgery, anxiety children; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Perioperative period

Study Arms (2)

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

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

Interventions

Selection of parent(mother or father) according to children preference PROCEDURE

The parent who will accompany the child during the perioperative period will be determined by the child. will be determined by children preference

Group Child Preference

Parent (mother or father) selection according to parents' preference PROCEDURE

Accompanying parentwho will accompany during the perioperative period will be determined by the parents. to be determined by

Group Parent's Preference

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Child Behavior; Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatih Yücedağ, Assist Prof

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 5, 2023
• Study Start: July 4, 2023
• Primary Completion: September 27, 2023
• Study Completion: September 28, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-06

Locations

TU (1)