Anesthesia, GeneralMatherVoiceNCT02860377
Maternal Voice on Anesthetic Emergence Period
A study testing recorded maternal voice and recorded stranger's voice in people with Anesthesia, General, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- recorded maternal voice and recorded stranger's voice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients: a Pilot Study
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.
- Conditions
- Anesthesia, General
- Being tested
- recorded maternal voice, recorded stranger's voice
- Keywords
- emergence agitation, emergence time, pediatric
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recorded maternal voiceProcedure or surgery
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.
recorded stranger's voiceProcedure or surgery
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. "
| Study group | Role | What they receive |
|---|---|---|
| stranger's voice | Active comparator | At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation. Receives: Procedure: recorded stranger's voice |
| maternal voice | Experimental | At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation. Receives: Procedure: recorded maternal voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence time
time from discontinuation of anesthetics to extubation
Measured: During 1 hour after operation
Incidence of emergence delirium (ED)
The incidence of emergence delirium (ED) was defined as pediatric anesthesia emergence delirium (PAED) score of >12 or Watcha scale over 3.
Measured: During 30 minutes after PACU admission
Secondary outcomes (4)
peak PAED scale
The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.
Measured: During 30 minutes after PACU admission
peak Watcha scale
The Watcha scale is a four-point as followings.
- calm
- crying, but can be consoled
- Crying, cannot be consoled
- Agitated and thrashing around
Measured: During 30 minutes after PACU admission
eye opening or purposeful movement time
time from discontinuation of anesthetics to spontaneous eye opening
Measured: During 1 hour after operation
BIS over 60
At the end of operation, investigators stop the anesthetics and carefully watch the bispectral index (BIS) monitor. Simultaneously, investigators check the duration of time from discontinuation of anesthetics until the BIS >60.
Measured: During 1 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Kim, Daegu Catholic University Medical Center
- Investigators
- Eugene Kim, MD, Study director, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860377
- Sponsor's protocol ID
- DCUMC_1
- Acronym
- MatherVoice
- Status last verified
- Jan 2020
- First submitted
- 3 Aug 2016
- Last updated
- 29 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT02860377
- Acronym / sponsor ID
- MatherVoice / DCUMC_1
- Conditions
- Anesthesia, General
- Keywords
- emergence agitation, emergence time, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stranger's voice | Active comparator | Procedure: recorded stranger's voiceAt the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation. |
| maternal voice | Experimental | Procedure: recorded maternal voiceAt the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recorded maternal voiceA 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. | Procedure or surgery | maternal voice |
| recorded stranger's voiceA 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. " | Procedure or surgery | stranger's voice |
Primary outcome
Emergence time
Time frame: During 1 hour after operation
time from discontinuation of anesthetics to extubation
Incidence of emergence delirium (ED)
Time frame: During 30 minutes after PACU admission
The incidence of emergence delirium (ED) was defined as pediatric anesthesia emergence delirium (PAED) score of >12 or Watcha scale over 3.
4 secondary outcomes
peak PAED scale
Time frame: During 30 minutes after PACU admission
peak Watcha scale
Time frame: During 30 minutes after PACU admission
eye opening or purposeful movement time
Time frame: During 1 hour after operation
BIS over 60
Time frame: During 1 hour after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Kim, MD study director
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recorded maternal voice and recorded stranger's voice in people with Anesthesia, General, run by Daegu Catholic University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence time (time frame: During 1 hour after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.