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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05931770
• Other study ID #: 06-2023/11
• Status: Completed
• Start date: July 4, 2023
• Est. completion date: September 28, 2023

Study information

• Verified date: June 2023
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 28, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Child Behavior
• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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