Trial Review

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
ACTRN12625000886482
Ethics application status
Approved
Date submitted
17/06/2025
Date registered
13/08/2025
Date last updated
13/08/2025
Date data sharing statement initially provided
13/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes after surgery and the real impact of children’s health literacy (OSTRICH)
Scientific title
Outcomes after surgery and the real impact of children’s health literacy (OSTRICH)
Secondary ID [1] 314757 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
OSTRICH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Health 337667 0
Public Health 337668 0
Condition category
Condition code
Public Health 334001 334001 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The objective of this project is to assess if a child's health literacy score can predict outcome after their surgery as measured by the Pictorial adaptation of QoR-15F. Participants (children aged 8 -15 years old undergoing elective surgery at Perth Children's Hospital and their parents) will be approached by the research team to participate in the study, REDCap e-consents or paper consent forms will be used to collect consent for participation. Participants will be asked to complete an online questionnaire prior to their surgery. This questionnaire will include collection of child demographics (age, gender, sex), school year, primary caregiver's highest education attained, the Home Literacy Environment (HLE) single-item measure (number of children's books in the home), and each item of the translated HLS-Child-Q15 as well as the health literacy for the primary caregiver (HLA-EU-Q47). Three questions designed to measure self-efficacy (“I can trust in my knowledge and abilities,” “I can find a solution for most problems,” and “If I make an effort, I will succeed”, measured on a four-point scale of agreement) will also be included in the online child questionnaire). Data from the patient's medical records including their height, weight, respiratory risk factors, post operative nausea and vomiting risk factors, surgical speciality, type of surgical procedure, anaesthetic and PACU management on the day of surgery will also be collected.
Further online surveys will be automatically sent to participants l 1 day, 7 days and 28 days after their surgeries via REDCap. These questionnaires will collect data on surgical outcomes including representations, pain management, return to normal function, healing and complications. We will also assess whether the recovery matches the parental and child expectations and how satisfied they were with their surgery and subsequent recovery. Participants will receive automatic reminders if they do not complete the survey. If they do not complete the survey, there will be attempts made to call the family and complete the survey over the phone.

Recruitment for the study will continue until there are 300 complete sets of the three post-surgery questionnaires.
Intervention code [1] 331227 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341955 0
Assess if health literacy can predict outcomes after surgery as measured by the pictorial adaptation of QoR-15F
Timepoint [1] 341955 0
7 days post-surgery
Secondary outcome [1] 448511 0
Determine the incidence of immediate postoperative outcomes (as a composite outcome) including emergence delirium assessed by the patient's PACU nurse using PAED scores 10 minutes after patient is awake, incidence of postoperative nausea and vomiting as reported by the patient's PACU nurse.
Timepoint [1] 448511 0
Assessed immediately post-surgery in PACU
Secondary outcome [2] 448512 0
Determine the incidence of any postoperative respiratory adverse events (as a composite outcome) during surgery and in the PACU. PRAE are defined as: Laryngospasm: complete airway obstruction with associated muscle rigidity of the abdominal and chest walls. Bronchospasm: increased respiratory effort particularly during expiration and wheeze on auscultation, Desaturation: Oxygen saturation < 95% for >10secs on pulse oximetry, Airway obstruction: the presence of airway obstruction with a snoring noise and/or increased respiratory efforts. Severe persistent coughing: pronounced, persistent coughs lasting more than 10 seconds. Post-operative stridor: high pitched sound during breathing in the postoperative period
Timepoint [2] 448512 0
PRAE will be assessed at induction, maintenance, emergence and recovery from anaesthesia
Secondary outcome [3] 448513 0
Child rated pain on day 1 post-surgery
Timepoint [3] 448513 0
Measured on 1 day post-surgery
Secondary outcome [4] 448514 0
Quality of recovery as assessed by QoR-15F, the general recovery rating (from 0 to 10), return to normal function and recovery expectations (as a composite outcome) on postoperative day 1, 7 and 28 by parent and child as applicable
Timepoint [4] 448514 0
1 day, 7 days and 28 days post-surgery
Secondary outcome [5] 448531 0
Determine the incidence of parent reported pain using the parents post-operative pain measure (PPPM) and global pain score (as a composite outcome)
Timepoint [5] 448531 0
1 day, 7 days and 28 days post-surgery.
Secondary outcome [6] 448532 0
Incidence of unplanned re-presentations, re-admissions, complications, and surgical site infections (if applicable) as a composite secondary outcome
Timepoint [6] 448532 0
1 day, 7 days and 28 days post-surgery.
Secondary outcome [7] 449157 0
Parent reported child’s quality of life measured with the parent version of the PedsQL prior to surgery and postoperatively on day 28.
Timepoint [7] 449157 0
Prior to surgery and 28 days post-surgery
Secondary outcome [8] 449158 0
Child reported quality of life measured by the child version of the PedsQL prior to surgery and postoperatively on day 28
Timepoint [8] 449158 0
Prior to surgery and 28 days post-surgery

Eligibility
Key inclusion criteria
- Children aged 8 - 15 years old who have surgery at Perth Children's Hospital and their parents/primary caregivers,
- ASA 1, 2, or 3.
- Urgency of surgery categories 3 to 5.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Parents/ caregivers/ child with an insufficient level of English to consent to inclusion.
•Children with significant neurodevelopmental delay, unable to complete the questionnaires.
•Urgency of surgery Categories 1 or 2.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size
For the purpose of sample size calculation, we will use the response as the total recovery score on day 7, as measured by the Pictorial adaptation of QoR-15F. Based on a linear regression model of the response with the individual scores from the fifteen questions, gender, age and BMI as covariates, and using a moderate correlation of 0.25 (pain scores often have large variation), we obtain a sample size of 235 for 95% power. Allowing for lack of follow up and missing data, we select a sample size of 300.

Data Analysis:
Statistical analysis will be conducted in the R statistical environment and statistical significance will be taken at 5% (0.05). The number and proportion of participants who opened but did not complete the surveys will be reported. Descriptive statistics will be performed on demographics, HLE, Child Self-efficacy, recovery expectations, and HLS-Child-Q15 items to assess the behaviour of the data.

Statistical modelling will include the following.
The following models will be fitted to the data.
1. Linear regression model with the total recovery score on day 7 as response. The covariates will include the individual scores of the HLS-Child-Q15 questionnaire, gender, age and BMI.
2. Linear regression model with the total recovery score on day 7 as response. The covariates will include the total score of the HLS-Child-Q15 questionnaire, gender, age and BMI.
3. Linear mixed-effects (repeated measures) model for the recovery score over the days as response. The covariates will include the total score of the HLS-Child-Q15 questionnaire, gender, age and BMI. A random intercept for child will be included. Variance models will also be considered. 4. The secondary outcomes, such as the changes in the recovery rating (0-10), pain (PPPM), and quality of life (QoL) over the days will be modelled using linear mixed-effects models. Covariates will include the total score of the HLS-Child-Q15 questionnaire and a random intercept for child will be used. Secondary outcomes for the incidence of emergence delirium, PONV and re-presentations or surgical site infections will be modelled using binomial logistic regression models for each outcome. Similarly to the above models, appropriate covariates will be included along with the total score of the HLS-Child-Q15 questionnaire score.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 28009 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 44212 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318996 0
Hospital
Name [1] 318996 0
Perth Children's Hospital
Country [1] 318996 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service, Government of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 321461 0
None
Name [1] 321461 0
Address [1] 321461 0
Country [1] 321461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317609 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 317609 0
Ethics committee country [1] 317609 0
Australia
Date submitted for ethics approval [1] 317609 0
28/04/2025
Approval date [1] 317609 0
17/06/2025
Ethics approval number [1] 317609 0
RGS0000007567

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

Contacts
Principal investigator
Name 141550 0
Prof Britta von Ungern-Sternberg
Address 141550 0
Department of Anaesthesia & Pain Medicine, Perth Children's Hospital 15 Hospital Avenue, Nedlands 6009 WA
Country 141550 0
Australia
Phone 141550 0
+61 0420790101
Fax 141550 0
Email 141550 0
[email protected]
Contact person for public queries
Name 141551 0
Britta von Ungern-Sternberg
Address 141551 0
Department of Anaesthesia & Pain Medicine, Perth Children's Hospital 15 Hospital Avenue, Nedlands 6009 WA
Country 141551 0
Australia
Phone 141551 0
+61 0420790101
Fax 141551 0
Email 141551 0
[email protected]
Contact person for scientific queries
Name 141552 0
Britta von Ungern-Sternberg
Address 141552 0
Department of Anaesthesia & Pain Medicine, Perth Children's Hospital 15 Hospital Avenue, Nedlands 6009 WA
Country 141552 0
Australia
Phone 141552 0
+61 0420790101
Fax 141552 0
Email 141552 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sharing of individual participant data is not allowed by our HREC



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.