An interventional study of recorded maternal voice and recorded stranger's voice in Anesthesia, General, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Daegu Catholic University Medical Center · Not applicable, Interventional, and Supportive care
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.
Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.
Procedure: recorded stranger's voice
At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation.
Procedure: 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.
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. "
Emergence time
time from discontinuation of anesthetics to extubation
Time frame: 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.
Time frame: During 30 minutes after PACU admission
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.
Time frame: During 30 minutes after PACU admission
peak Watcha scale
The Watcha scale is a four-point as followings. 1. calm 2. crying, but can be consoled 3. Crying, cannot be consoled 4. Agitated and thrashing around
Time frame: During 30 minutes after PACU admission
eye opening or purposeful movement time
time from discontinuation of anesthetics to spontaneous eye opening
Time frame: 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.
Time frame: During 1 hour after operation
peak FLACC score
Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission.
Time frame: During 30 minutes after PACU admission
The amount of analgesic/anesthetic consumption at PACU/ward
The amount of analgesics/anesthetic consumption was checked during hospital admission. At PACU, a total PAED score of \>12 or a FLACC scale \>4, intravenous fentanyl 0.5 mcg/kg was administered as rescue medication and repeated after 10 min if the agitation does not subside.
Time frame: During 1 hour at PACU
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Daegu Catholic University Medical Center