Effect of Child Preference for Parental Selection During Induction

Sponsor

Karaman Training and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05646927

Collaborator

(none)

Enrollment

Location

1.4

Anticipated Duration (Months)

56.6

Patients Per Site Per Month

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. 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.

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

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 13, 2022

Actual Primary Completion Date :

Jan 23, 2023

Anticipated Study Completion Date :

Jan 25, 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 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.

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 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.

Outcome Measures

Primary Outcome Measures

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:

4 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Mentally challenged
Deaf Child
Cerebral Palsy
Premedicated Child
Language Problem
Unco-operative
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 Yucedag, 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:

NCT05646927

Other Study ID Numbers:

09-2022/04

First Posted:

Dec 12, 2022

Last Update Posted:

Jan 25, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karaman Training and Research Hospital

day- case surgery

anxiety

children

Study Results

No Results Posted as of Jan 25, 2023