Effect of Child Preference for Parental Selection During Induction

Child Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05646927
• Other study ID #: 09-2022/04
• Status: Completed
• Start date: December 13, 2022
• Est. completion date: February 14, 2023

Study information

• Verified date: December 2022
• 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. 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 14, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety State
• Child Behavior

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 children preference
• 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.

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	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