Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001569897
Ethics application status
Approved
Date submitted
13/10/2021
Date registered
18/11/2021
Date last updated
18/11/2021
Date data sharing statement initially provided
18/11/2021
Date results information initially provided
18/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of recorded parental voice on emergence agitation and pain in children after general anesthesia: A cluster randomized controlled trial
Scientific title
Effects of recorded parental voice on emergence agitation and pain in children after general anesthesia: A cluster randomized controlled trial
Secondary ID [1] 305548 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emergence agitation 323940 0
pain 323941 0
Condition category
Condition code
Mental Health 321454 321454 0 0
Other mental health disorders
Anaesthesiology 321644 321644 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321945 0
Treatment: Other
Comparator / control treatment
The control group, as well as the intervention group, continued to receive routine therapy and anesthetic nursing measures. However, the control group did not receive any intervention from the project in addition to this.
Control group
Active

Outcomes
Primary outcome [1] 329233 0
Emergence agitation assessed by the Sedation-Agitation Scale (SAS)
Timepoint [1] 329233 0
pre-treatment: at the moment pediatric patients under general anesthesia removed their intubation
post-treatment: at the moment pediatric patients under general anesthesia moved out of PACU
Secondary outcome [1] 401852 0
pain assessed by the Face, Legs, Activity, Cry and Consolability Scale (FLACC)
Timepoint [1] 401852 0
pre-treatment: at the moment pediatric patients under general anesthesia removed their intubation
post-treatment: at the moment pediatric patients under general anesthesia moved out of PACU

Eligibility
Key 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.
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After being screened for eligibility and providing signed informed consent by participants’ parents. Children were randomized to the control and intervention groups using the random cluster method with the help of a nurse. Randomization was stratified according to children’s operation time (i.e., morning or afternoon of each day), and clusters were assigned in a 1:1 ratio to either the intervention group (i.e., recorded parental voice group) or the control group (i.e., routine nursing group) using a sortition randomization method.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
1/02/2017
Date of last data collection
Anticipated
Actual
31/05/2017
Sample size
Target
220
Accrual to date
Final
220
Recruitment outside Australia
Country [1] 24205 0
China
State/province [1] 24205 0
Shandong

Funding & Sponsors
Funding source category [1] 309914 0
Self funded/Unfunded
Name [1] 309914 0
Meiling Qi
Country [1] 309914 0
China
Primary sponsor type
Individual
Name
QIaomei Sun
Address
Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country
China
Secondary sponsor category [1] 310945 0
Individual
Name [1] 310945 0
Meiling Qi
Address [1] 310945 0
Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country [1] 310945 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309634 0
Shandong University Human Research Ethics Committee
Ethics committee address [1] 309634 0
44 Wenhua Road, Jinan, Shandong, China, 250012
Ethics committee country [1] 309634 0
China
Date submitted for ethics approval [1] 309634 0
Approval date [1] 309634 0
15/10/2016
Ethics approval number [1] 309634 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
More than 70% of the recording providers were their mothers and almost 20% of the recorded voice provider were grandparents. The recording contents included nursery rhymes and encouraging words (90%). Both nursery rhymes and encouraging words were recorded by their parents themselves. Almost all the recording files lasts less than 90 seconds, with half of them were less than 30 seconds.

Contacts
Principal investigator
Name 114850 0
Dr Meiling Qi
Address 114850 0
School of Nursing and Rehabilitation, Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country 114850 0
China
Phone 114850 0
+86 19953101313
Fax 114850 0
Email 114850 0
[email protected]
Contact person for public queries
Name 114851 0
A/Prof Ping li
Address 114851 0
School of Nursing and Rehabilitation, Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country 114851 0
China
Phone 114851 0
+86 18853115050
Fax 114851 0
Email 114851 0
[email protected]
Contact person for scientific queries
Name 114852 0
A/Prof Ping li
Address 114852 0
School of Nursing and Rehabilitation, Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country 114852 0
China
Phone 114852 0
+86 18853115050
Fax 114852 0
Email 114852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data underlying published results only
When will data be available (start and end dates)?
The data will be available immediately following publication, and available for 5 years after publication.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (Prof Ping Li email at [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13552Statistical analysis plan  [email protected] 382948-(Uploaded-13-10-2021-20-12-51)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ThesisNo http://med.wanfangdata.com.cn/Paper/Detail?id=Degr... [More Details]
Basic resultsNo 382948-(Uploaded-13-10-2021-20-23-27)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.