Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001028190
Ethics application status
Approved
Date submitted
3/07/2019
Date registered
18/07/2019
Date last updated
24/01/2023
Date data sharing statement initially provided
18/07/2019
Date results provided
24/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of communicating with families about their child’s pain at home after tonsillectomy using automated SMS messages
Scientific title
Feasibility of communicating with families about their child’s pain at home after tonsillectomy using automated SMS messages
Secondary ID [1] 298638 0
Nil known
Universal Trial Number (UTN)
U1111-1236-2965
Trial acronym
RACUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric post-operative pain following tonsillectomy 313521 0
Condition category
Condition code
Public Health 311957 311957 0 0
Health service research
Anaesthesiology 312022 312022 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating families will receive SMS message follow-up each day post-operatively requesting that parents report their child's daily pain score using a zero-to-ten (zero being no pain, ten being worst possible pain) parental proxy numerical rating scale. This follow-up will continue daily until either zero pain is reported on two consecutive days, or no response is received for two days. Messages will be sent automatically, and responses will be coded automatically where possible. When parents respond with a pain score of four or greater generic advice regarding pain medication and seeking medical review will be provided. When parents respond with a pain score of eight or greater a researcher will be notified to determine if the family should be contacted by clinical staff. Responses that cannot be coded automatically will be coded by a researcher. After follow-up is completed families will be asked to provide quantitative and qualitative feedback on how they felt about the SMS follow-up.
Intervention code [1] 314903 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320614 0
Response rates for each day of follow-up
Timepoint [1] 320614 0
Each post-operative day until either pain is resolved, no reply is received for three consecutive days, or further participation is declined
Secondary outcome [1] 372200 0
Proportion of families who are lost to follow-up each day
Timepoint [1] 372200 0
Each post-operative day until either pain is resolved, no reply is received for three consecutive days, or further participation is declined
Secondary outcome [2] 372201 0
Proportion of all first responses to pain score messages that were able to be coded automatically
Timepoint [2] 372201 0
At the completion of data collection from all participants
Secondary outcome [3] 372202 0
Proportion of all first responses to pain score messages that require manual researcher intervention for coding or follow-up
Timepoint [3] 372202 0
At the completion of data collection from all participants
Secondary outcome [4] 372203 0
Pain scores for each post-operative day, as assessed by parental proxy zero-to-ten numerical rating scale. This will be presented as median pain scores, range of pain scores, and rate of mild/moderate/severe pain scores.
Timepoint [4] 372203 0
Each post-operative day until either pain is resolved, no reply is received for three consecutive days, or further participation is declined
Secondary outcome [5] 372204 0
Parental satisfaction with SMS messages, measured by five-point Likert scale
Timepoint [5] 372204 0
At the completion of data collection from all participants
Secondary outcome [6] 372205 0
Parental satisfaction with SMS messages, assessed by thematic analysis of free responses
Timepoint [6] 372205 0
At the completion of data collection from all participants

Eligibility
Key inclusion criteria
Children who are undergoing tonsillectomy at Perth Children's Hospital where the mobile phone number of the child’s parent or guardian is known
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will consist of descriptive statistics over the whole dataset and subgroups for each site. No comparative statistics will be attempted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2019
Actual
24/09/2019
Date of last participant enrolment
Anticipated
28/02/2020
Actual
28/01/2021
Date of last data collection
Anticipated
Actual
26/02/2021
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14130 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 26940 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303178 0
Hospital
Name [1] 303178 0
Perth Children's Hospital
Country [1] 303178 0
Australia
Funding source category [2] 303181 0
University
Name [2] 303181 0
University of Western Australia
Country [2] 303181 0
Australia
Primary sponsor type
Individual
Name
Prof Britta von Ungern-Sternberg
Address
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 303190 0
None
Name [1] 303190 0
Address [1] 303190 0
Country [1] 303190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303741 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 303741 0
Ethics committee country [1] 303741 0
Australia
Date submitted for ethics approval [1] 303741 0
Approval date [1] 303741 0
06/06/2019
Ethics approval number [1] 303741 0
RGS0000003157

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94634 0
Prof Britta von Ungern-Sternberg
Address 94634 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 94634 0
Australia
Phone 94634 0
+61420790101
Fax 94634 0
Email 94634 0
[email protected]
Contact person for public queries
Name 94635 0
Britta von Ungern-Sternberg
Address 94635 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 94635 0
Australia
Phone 94635 0
+61420790101
Fax 94635 0
Email 94635 0
[email protected]
Contact person for scientific queries
Name 94636 0
Britta von Ungern-Sternberg
Address 94636 0
Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country 94636 0
Australia
Phone 94636 0
+61420790101
Fax 94636 0
Email 94636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of research team processes


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAuthor's Reply.2019https://dx.doi.org/10.1177/0310057X19877192
EmbaseRemote after-care using smartphones: A feasibility study of monitoring children's pain with automated SMS messaging.2022https://dx.doi.org/10.1111/pan.14481
N.B. These documents automatically identified may not have been verified by the study sponsor.