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

NCT ID: NCT05931770

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-04

Study Completion Date

2023-09-28

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Anxiety State Child Behavior Postoperative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group Child Preference

The children will prefer parents (mother or father) who will accompany them in the preoperative holding area and at induction

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

Intervention Type PROCEDURE

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.

Parent (mother or father) selection according to parents' preference

Intervention Type PROCEDURE

Accompanying parentwho will accompany during the perioperative period will be determined by the parents. to be determined by

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karaman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fatih Yücedağ, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Karaman Training and Research Hospital

Locations

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Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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06-2023/11

Identifier Type: -

Identifier Source: org_study_id

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