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Effects of recorded parental voice on emergence agitation and pain in children after general anesthesia: A cluster randomized controlled trial

Effects of recorded parental voice on emergence agitation and pain in children after general anesthesia: A cluster randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001569897
Enrollment
220
Registered
2021-11-18
Start date
2016-12-01
Completion date
2017-02-01
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study was to examine the effectiveness of recorded voice provided by both parents and grandparents on emergence agitation and pain in pediatric patients under general anesthesia with endotracheal intubation. A cluster randomized controlled trial was applied in this study, with 220 pediatric patients aged 1-6 years recruited and randomly assigned to an intervention (n = 104) or control group (n = 116). Both groups receive routine nursing, while participants in the intervention group received recorded parental voice immediately after intubation removal (i.e., pre-treatment) and completed at the time of leaving PACU (i.e., post-treatment). Both emergence agitation and pain scores were collected at pre-treatment and post-treatment.

Interventions

Before the operation, parents were instructed by the research and nurses to record the words in a quiet environment in their usual voice and intonation they used to talk with their children. They were informed that there was no restriction of the recording content and length. The details of the collected recording files (n = 98) in the intervention group. The intervention group received the recorded voice files. Emergence agitation (EA) generally occurs about 15 minutes after intubation removal

Before the operation, parents were instructed by the research and nurses to record the words in a quiet environment in their usual voice and intonation they used to talk with their children. They were informed that there was no restriction of the recording content and length. The details of the collected recording files (n = 98) in the intervention group. The intervention group received the recorded voice files. Emergence agitation (EA) generally occurs about 15 minutes after intubation removal. Therefore, it is very important to take intervention measures after intubation removal to pacify children and reduce the occurrence of EA. Thus, the children were transferred to the PACU after the operation and were assigned the corresponding recording files to start the intervention immediately after removing their intubation (i.e., pre-treatment). The recorded voice was played on repeat from removing of the intubation until children were moved out of the PACU (i.e., post-treatment), this could range from 15-30 minutes. Both the EA and pain were collected at these two-time points.

Sponsors

QIaomei Sun
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

Participants were included in this study if they were children (aged 1-6 years) with an American Society of Anesthesiologic (ASA) physical status of I or II, who underwent general anesthesia with endotracheal intubation, transferred to the PACU after the operation, had normal hearing, and had no consciousness and mental disorders.

Exclusion criteria

The exclusion criteria included the following: (a) developmental delays or neurological or psychiatric diseases; (b) autism; (c) a recent history (within a month) of receiving general anesthesia or surgery; (d) congenital or other genetic conditions thought to influence brain development; and (e) intubation removal before transferring to the PACU.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026