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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]

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

Condition category

Condition code

Public Health

Health service research

Anaesthesiology

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]

Other interventions

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Response rates for each day of follow-up

Timepoint [1]

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]

Proportion of families who are lost to follow-up each day

Timepoint [1]

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]

Proportion of all first responses to pain score messages that were able to be coded automatically

Timepoint [2]

At the completion of data collection from all participants

Secondary outcome [3]

Proportion of all first responses to pain score messages that require manual researcher intervention for coding or follow-up

Timepoint [3]

At the completion of data collection from all participants

Secondary outcome [4]

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]

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]

Parental satisfaction with SMS messages, measured by five-point Likert scale

Timepoint [5]

At the completion of data collection from all participants

Secondary outcome [6]

Parental satisfaction with SMS messages, assessed by thematic analysis of free responses

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Perth Children's Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Perth Children's Hospital

Address [1]

15 Hospital Ave
Nedlands WA 6009

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Western Australia

Address [2]

35 Stirling Hwy
Crawley WA 6009

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Service Human Research Ethics Committee

Ethics committee address [1]

Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/06/2019

Ethics approval number [1]

RGS0000003157

Summary

Brief summary

Often research to improve the care of children after surgery involves following up patient recovery at home. Until now this has been done at Perth Children's Hospital by telephone interview, however telephone follow-up is time consuming and might be inconvenient for families. We will test an automated interactive SMS messaging system to communicate with families about their child’s pain at home after tonsillectomy with 100 families. We expect that this will be easier for researchers and more convenient for families, and that we will be able to contact more families successfully using this method.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

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

Phone

+61420790101

Fax

Britta.Regli-VonUngern@health.wa.gov.au

Contact person for public queries

Name

Britta von Ungern-Sternberg

Address

Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009

Country

Australia

Phone

+61420790101

Fax

Britta.Regli-VonUngern@health.wa.gov.au

Contact person for scientific queries

Name

Britta von Ungern-Sternberg

Address

Department of Anaesthesia and Pain Management
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009

Country

Australia

Phone

+61420790101

Fax

Britta.Regli-VonUngern@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Author's Reply.	2019	https://dx.doi.org/10.1177/0310057X19877192
Embase	Remote after-care using smartphones: A feasibility study of monitoring children's pain with automated SMS messaging.	2022	https://dx.doi.org/10.1111/pan.14481

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically