Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 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
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
Trial website
Trial related presentations / publications
Public notes

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
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
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 the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• all of the individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
The data will be available immediately following publication, and available for 5 years after publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator (Prof Ping Li email at [email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13552Statistical analysis plan  [email protected] Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.