Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001426774
Ethics application status
Approved
Date submitted
28/10/2022
Date registered
8/11/2022
Date last updated
23/01/2023
Date data sharing statement initially provided
8/11/2022
Date results information initially provided
23/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring pain in children and developing new technologies to address challenges
Scientific title
QUENDA: QUalitative Exploration to uNderstand pain in children and Develop novel technologies to Address challenges
Secondary ID [1] 308300 0
None
Universal Trial Number (UTN)
Trial acronym
QUENDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 328085 0
Paediatric surgery 328086 0
Condition category
Condition code
Anaesthesiology 325142 325142 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Recruited participants will be asked to complete a single semi-structured interview lasting approximately 30 minutes, conducted by a trained member of the research team.
The interview will include collection of demographics for children (age, gender) and parents (age, gender, profession), and details of premorbid pain conditions or exposures. Child healthcare literacy will be assessed using the HLS-Child-Q15, and parent healthcare literacy will be assessed using the Newest Vital Sign. The remainder of the interview will consist of open questions and follow-up prompts regarding pain experiences and views following the Interview Guide.
The interview will be conducted within 5 days of the child undergoing a surgical procedure, presenting to the emergency department or being admitted to a hospital ward for acute pain.
There is no other activity or treatment involved in participation in this study.

Results from this study will help guide future directions for the study team in using mobile devices and digital technology to better assess children's pain. The study participants for this study are not planned to be included in any further research apart from this study.
Intervention code [1] 324752 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332968 0
Identify key themes related to children’s and parent’s lived experience of and views regarding paediatric pain in acute settings, with particular focus on exploring; Children’s perceptions of their ability to understand and communicate their pain, in a semi-structured, one-on-one face-to-face interview with a member of the research team
Timepoint [1] 332968 0
Within 5 days of a surgical procedure, presentation to the emergency department or admission to a hospital ward for acute pain.
Primary outcome [2] 332969 0
Identify key themes related to children’s and parent’s lived experience of and views regarding paediatric pain in acute settings, with particular focus on exploring: Parental perceptions of their children’s ability to understand and communicate pain in a semi-structured, one-on-one face-to-face interview with a member of the research team
Timepoint [2] 332969 0
Within 5 days of a surgical procedure, presentation to the emergency department or admission to a hospital ward for acute pain.
Primary outcome [3] 332970 0
Identify key themes related to children’s and parent’s lived experience of and views regarding paediatric pain in acute settings, with particular focus on exploring: Children’s and parent’s use of different words/concepts to identify this experience (e.g. “pain”, “sore”, “hurt”, “distress”, “discomfort”) as well as words/concepts to identify contrasting experiences (“comfort”, “feeling good”, “feeling okay”) in a semi-structured, one-on-one face-to-face interview with a member of the research team
Timepoint [3] 332970 0
Within 5 days of a surgical procedure, presentation to the emergency department or admission to a hospital ward for acute pain.
Secondary outcome [1] 415371 0
Identify key themes related to children’s and parent’s lived experience of and views regarding paediatric pain in acute settings, with particular focus on exploring: Associations between experiences of pain and other sensory experiences (e.g. visual: colours, movement, flashing, auditory: pitch, tone) in a semi-structured, one-on-one face-to-face interview with a member of the research team
Timepoint [1] 415371 0
Within 5 days of a surgical procedure, presentation to the emergency department or admission to a hospital ward for acute pain.
Secondary outcome [2] 415470 0
Child healthcare literacy will be assessed using the HLS-Child-Q15
Timepoint [2] 415470 0
At the time of recruitment into the study
Secondary outcome [3] 415471 0
Parent healthcare literacy will be assessed using the Newest Vital Sign
Timepoint [3] 415471 0
At the time of recruitment into the study

Eligibility
Key inclusion criteria
Children aged 0 to 16 years and/or their parents will be included who have in the preceding 5 days:
• undergone a surgical procedure, or
• presented to the Emergency Department with a condition associated with acute pain, or
• been admitted to the ward with a condition associated with acute pain.
For children aged less than 4 years, only their parents will be included. For children 4 or more years of age, both children and their parents will be included.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with parents who are not able to understand sufficient English to consent to inclusion in the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size
Recruitment will continue until data saturation is achieved. From experience we expect that this will occur at or before the recruitment of 25 families. Data saturation is the point whereby no new themes can be identified and will be determined by consensus among the research team.
We will stratify in three age groups: under 6 years, 6 to 11 years, and 12 to 16 years old with at least 6 families in each stratum to ensure broad age group representation.

Analytical methods
Descriptive (quantitative) statistics of demographic information will be performed. Thematic analysis will be undertaken with the assistance of qualitative data analysis software (MAXQDA), following the Framework Method as outlined below.

Transcription
Following each interview, the audio recording will be transcribed, and then imported into qualitative data management software (MAXQDA) for analysis. Where participants have specifically consented, audio recordings may be provided to a suitably qualified external agency for transcription by secure file transfer, in other cases the research team will perform the transcription internally.

Familiarisation with the interview
Three members of the research team will familiarise themselves with all interview transcripts by reading the transcripts.

Coding
Analyst triangulation will be used during the coding process. The first three transcripts will be firstly independently coded by three researchers and discrepancies will be discussed and reconciled as necessary through consensus. This will ensure multiple interpretations are captured and discussed, thereby increasing the richness and trustworthiness of the findings.

Developing a working analytical framework
After coding these initial transcripts, a working analytical framework will be developed, consisting of codes with associated definitions, which will be further refined as further transcripts are coded.

Applying the analytical framework
Each transcript will be coded based on the analytical framework. New codes and definitions added to the analytical framework will be discussed between members of the research team.

Charting data onto the framework matrix
Data from the coded transcripts will be charted onto a framework matrix, showing participant data for each code, including direct and/or summarised participant quotes. Codes will be tentatively grouped together according to emerging themes.

Interpreting the data
Final themes will be identified by mapping connections within and between participant responses, and making analytical memos for each theme identified.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2022
Actual
18/11/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
19/12/2022
Date of last data collection
Anticipated
6/04/2023
Actual
19/12/2022
Sample size
Target
25
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23469 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 38877 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312550 0
Hospital
Name [1] 312550 0
Perth Children's Hospital
Country [1] 312550 0
Australia
Primary sponsor type
Hospital
Name
Child and Adolescent Health Service
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 314152 0
None
Name [1] 314152 0
Address [1] 314152 0
Country [1] 314152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311877 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 311877 0
Child and Adolescent Health Service Human Research Ethics Committee
15 Hospital Avenue
Nedlands
Western Australia 6009
Ethics committee country [1] 311877 0
Australia
Date submitted for ethics approval [1] 311877 0
20/09/2022
Approval date [1] 311877 0
26/10/2022
Ethics approval number [1] 311877 0
RGS0000005585

Summary
Brief summary
QUENDA is part of a broader research program aimed at using mobile devices and digital technology to better assess children’s pain. Digital mobile technology (e.g. mobile phones, tablets) can enable pain assessment tools that are interactive and respond to children’s inputs. The broader program seeks to embrace the potential of digital-enabled interactive tools and create new approaches to the assessment of pain that are better for kids, allow more engagement, and therefore give clinicians better insight into children’s pain, and enable better care. QUENDA is the first step in the program and is designed to better understand how children perceive and communicate their pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122690 0
Prof Britta von Ungern-Sternberg
Address 122690 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122690 0
Australia
Phone 122690 0
+61 420790101
Fax 122690 0
Email 122690 0
[email protected]
Contact person for public queries
Name 122691 0
Prof Britta von Ungern-Sternberg
Address 122691 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122691 0
Australia
Phone 122691 0
+61 420790101
Fax 122691 0
Email 122691 0
[email protected]
Contact person for scientific queries
Name 122692 0
Dr Thomas Drake-Brockman
Address 122692 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122692 0
Australia
Phone 122692 0
+61 422857810
Fax 122692 0
Email 122692 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
Team haven't decided on this process yet.


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
No additional documents have been identified.