Maternal Voice on Anesthetic Emergence Period

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

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-09-30

Brief Summary

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Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.

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Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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stranger's voice

At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.

Group Type ACTIVE_COMPARATOR

recorded stranger's voice

Intervention Type PROCEDURE

A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences.

" OO (first name of child), wake up\~. Let's go home with mommy. OO, wake up\~. Open your eyes. Take a deep breath. "

maternal voice

At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation.

Group Type EXPERIMENTAL

recorded maternal voice

Intervention Type PROCEDURE

A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences.

" OO (first name of child), wake up\~. Let's go home with mommy. OO, wake up\~. Open your eyes. Take a deep breath. "

At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up.

Interventions

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recorded maternal voice

A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences.

" OO (first name of child), wake up\~. Let's go home with mommy. OO, wake up\~. Open your eyes. Take a deep breath. "

At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up.

Intervention Type PROCEDURE

recorded stranger's voice

A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences.

" OO (first name of child), wake up\~. Let's go home with mommy. OO, wake up\~. Open your eyes. Take a deep breath. "

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children aged between 2 and 8 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive an operation under general anesthesia

Exclusion Criteria

* ASA PS III or IV
* with developmental delay or neurological diseases associated with symptoms of agitation
* refusal of consent
* with developmental delay
* with allergy or contraindication to use of ketamine (presence of an active upper respiratory tract infection (URI), increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)

Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No