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

• Sponsor: Karaman Training and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05931770
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 3.5
• Patients Per Site Per Month: 23

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Anxiety State; Child Behavior; Postoperative Delirium	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 Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effect of Child Choice With Accompanying Parent on Pediatric Anxiety and Postoperative Delirium During Induction of Anesthesia During Day Case Surgeries.
• Actual Study Start Date: Jul 4, 2023
• Anticipated Primary Completion Date: Oct 16, 2023
• Anticipated Study Completion Date: Oct 18, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karaman Training and Research Hospital	Karaman		Turkey	70200

Sponsors and Collaborators

• Karaman Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karaman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05931770
• Other Study ID Numbers: 06-2023/11
• First Posted: Jul 5, 2023
• Last Update Posted: Jul 6, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Karaman Training and Research Hospital: day- case surgery, anxiety children; Postoperative Delirium
• Additional relevant MeSH terms: Delirium; Emergence Delirium; Anxiety Disorders

Study Results

No Results Posted as of Jul 6, 2023