Effect of Child Preference for Parental Selection During Induction

NCT05646927 | Completed DMC

• 1 other identifier: 09-2022/04
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State; Child Behavior

Keywords

day- case surgery; anxiety; children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Selection of parent(mother or father) according to children preference PROCEDURE

The parent who will accompany the child during the perioperative period will be determined by children preference

Group Child Preference

Selection of parent(mother or father) according to randomization PROCEDURE

The parent who will accompany the child during the perioperative period will be determined by randomization.

Group None

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• Mentally challenged
• Deaf Child
• Cerebral Palsy
• Premedicated Child
• Language Problem
• Unco-operative
• Previous surgery or anesthesia history

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (1)

• Fatih Y, Arife S, Aysegul B, Betul B. The Effect of Child Preference for Parental Selection on Pediatric Anxiety During Induction in Children Undergoing Elective Day Case Surgery. J Perianesth Nurs. 2024 Jun;39(3):397-402. doi: 10.1016/j.jopan.2023.08.021. Epub 2023 Dec 5.

  PMID: 38054915 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Child Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Fatih Yucedag, Assist Prof

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 12, 2022
• Study Start: December 13, 2022
• Primary Completion: January 23, 2023
• Study Completion: February 14, 2023
• Last Updated: February 15, 2023

Record last verified: 2022-12

Locations

TU (1)