Effect of Child Preference for Parental Selection During Induction

Effect of Child Preference for Parental Selection During Induction in Children Undergoing Elective Day Case Surgery

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. has not been documented.

The aim of this study will be to evaluate the effect of children's preference on parental selection during the induction of anesthesia on children and parental anxiety during the perioperative period.

Study Overview

• Status: Completed
• Conditions: Child Behavior; Anxiety State
• Intervention / Treatment: Procedure: Selection of parent(mother or father) according to children preference; Procedure: Selection of parent(mother or father) according to randomization

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 is not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS .

• 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 Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

80 children of both sex, aged 4-8 years with ASA physical Status I-II will be enrolled

Description

Inclusion Criteria:

• 80 children of both sex, aged 4-15 years with ASA physical Status I-II will be enrolled

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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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 children preference
Group None; The parent of the children who will accompany them during the perioperative period will be determined according to randomization.	Procedure: Selection of parent(mother or father) according to randomization; The parent who will accompany the child during the perioperative period will be determined by randomization.

What is the study measuring?

Primary 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

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: children; anxiety; day- case surgery
• Other Study ID Numbers: 09-2022/04

Drug and device information, study documents

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