Anesthesia, GeneralMaternal voiceNCT02955680
Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients
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
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to 21 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 ophthalmology or otorhinolaryngology surgery 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
- maternal mutism
- absence of mother
- with allergy or contraindication to use of ketamine (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: Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients
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 delirium, emergence time, bispectral index
- 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 |
|---|---|---|
| Group M | Experimental | At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation. Receives: Procedure: recorded maternal voice |
| Group S | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
initial PAED score
On arrival at post-anesthesia care unit (PACU), patients were checked PAED. 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 1 minutes after PACU admission
Secondary outcomes (10)
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
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 at PACU.
Measured: During 60 minutes after PACU admission
PAED score on 10, 20, and 30 min
On arrival at post-anesthesia care unit (PACU), patients were checked PAED. 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 60 minutes after PACU admission
Watcha scale on initial, 10, 20, and 30 min
On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale
- calm
- crying, but can be consoled
- Crying, cannot be consoled
- Agitated and thrashing around
Measured: During 60 minutes after PACU admission
BIS over 70 and 80 time
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 reached 70 and 80 value.
Measured: During 1 hour after operation
FLACC score on initial, 10, 20, and 30 min
Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
Measured: During 60 minutes after PACU admission
Extubation time
time from discontinuation of anesthetics to extubation
Measured: During 1 hour after operation
mean blood pressure
Mean blood pressure (MBP) is checked at five time points; cessation of anesthetics (baseline), the BIS reached value of 60, time of extubation, PACU arrival, and PACU discharge.
Measured: During 1 hour after operation
Heart rate
Heart rate is checked at five time points; cessation of anesthetics (baseline), the BIS reached value of 60, time of extubation, PACU arrival, and PACU discharge.
Measured: During 1 hour after operation
Eye opening or purposeful movement time
defined as the interval from the cessation of anesthetics to eye opening or purposeful movement of patients
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 posted4 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 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
- NCT02955680
- Sponsor's protocol ID
- DCUMC_2
- Acronym
- Maternal voice
- Status last verified
- Oct 2017
- First submitted
- 2 Nov 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
Publications
Byun S, Song S, Kim JH, Ryu T, Jeong MY, Kim E. Mother's recorded voice on emergence can decrease postoperative emergence delirium from general anaesthesia in paediatric patients: a prospective randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):483-489. doi: 10.1016/j.bja.2018.01.042. Epub 2018 Apr 17.
PubMed 30032889Song SY, Kwak SG, Kim E. Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial. Trials. 2017 Sep 15;18(1):430. doi: 10.1186/s13063-017-2164-4.
PubMed 28915907
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients
- ClinicalTrials.gov ID
- NCT02955680
- Acronym / sponsor ID
- Maternal voice / DCUMC_2
- Conditions
- Anesthesia, General
- Keywords
- emergence delirium, emergence time, bispectral index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 4 Nov 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Experimental | Procedure: recorded maternal voiceAt the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation. |
| Group S | 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. |
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 ophthalmology or otorhinolaryngology surgery under general anesthesia
Key exclusion criteria (6 listed)
- ASA PS III or IV
- with developmental delay or neurological diseases associated with symptoms of agitation
- refusal of consent
- maternal mutism
- absence of mother
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 | Group M |
| 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 | Group S |
Primary outcome
initial PAED score
Time frame: During 1 minutes after PACU admission
On arrival at post-anesthesia care unit (PACU), patients were checked PAED. 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.
10 secondary outcomes
BIS over 60
Time frame: During 1 hour after operation
Incidence of emergence delirium (ED)
Time frame: During 60 minutes after PACU admission
PAED score on 10, 20, and 30 min
Time frame: During 60 minutes after PACU admission
Watcha scale on initial, 10, 20, and 30 min
Time frame: During 60 minutes after PACU admission
BIS over 70 and 80 time
Time frame: During 1 hour after operation
FLACC score on initial, 10, 20, and 30 min
Time frame: During 60 minutes after PACU admission
Extubation time
Time frame: During 1 hour after operation
mean blood pressure
Time frame: During 1 hour after operation
Heart rate
Time frame: During 1 hour after operation
Eye opening or purposeful movement time
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 31 Oct 2017.
- Derived from this study: PubMed 30032889Byun S, Song S, Kim JH, Ryu T, Jeong MY, Kim E. Mother's recorded voice on emergence can decrease postoperative emergence delirium from general anaesthesia in paediatric patients: a prospective randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):483-489. doi: 10.1016/j.bja.2018.01.042. Epub 2018 Apr 17.
- Derived from this study: PubMed 28915907Song SY, Kwak SG, Kim E. Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial. Trials. 2017 Sep 15;18(1):430. doi: 10.1186/s13063-017-2164-4.
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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 6 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 31 Oct 2017. 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?
initial PAED score (time frame: During 1 minutes after PACU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955680, which also lists 2 linked publications.
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 31 Oct 2017.