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Trial registered on ANZCTR


Registration number
ACTRN12622001498785
Ethics application status
Approved
Date submitted
18/11/2022
Date registered
29/11/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
29/11/2022
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining anxiety and experiences of children, parents and staff in the perioperative environment through qualitative interviews.
Scientific title
ANxiety Themes and Experience: Learning through Qualitative Interviews with children. parents and staff to Optimise the Perioperative Environment
Secondary ID [1] 308301 0
Nil
Universal Trial Number (UTN)
Trial acronym
ANTELOPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 328087 0
Elective surgery 328088 0
Condition category
Condition code
Anaesthesiology 325143 325143 0 0
Anaesthetics
Surgery 325339 325339 0 0
Other surgery
Mental Health 325340 325340 0 0
Anxiety

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), parents (age, gender, profession (professional, healthcare, other), and details of any pre-existing anxiety. For staff and volunteers, we will record age, gender, profession (anaesthetic technician, nurse, doctor, volunteer). Child healthcare literacy will be assessed using the HLS-Child-Q15, and adult healthcare literacy will be assessed using the Newest Vital Sign. The demographic and health literacy data will be analysed to provide context. Children will be interviewed with their parents present with agreement with both the parent and child and if appropriate. Parents can be interviewed in the absence or presence of their children depending on the situation and preference of family. The interview guide is a study specific guide.
The remainder of the interview will consist of open questions and follow-up prompts regarding anxiety experiences and views following the Interview Guide.
There is no other activity or treatment involved in participation in this study.
Interviews with post surgical patients will be conducted within 1 month of their surgery.
Intervention code [1] 324753 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333151 0
To identify key themes related to children’s lived experiences of and views regarding anxiety in acute settings, particularly in the perioperative environment at Perth Children’s Hospital through semi structured, 30 minute interviews with a member of the research team.
Timepoint [1] 333151 0
In the post operative time period (within hours and days after surgery but no later than 1 month after surgery).
Primary outcome [2] 333152 0
To identify key themes related to parent’s lived experiences of and views regarding anxiety in acute settings, particularly in the perioperative environment at Perth Children’s Hospital through semi structured, 30 minute interviews with a member of the research team.
Timepoint [2] 333152 0
In the post operative time period (within hours and days after surgery but no later than 1 month after surgery).
Primary outcome [3] 333153 0
To identify key themes related to staff's lived experiences of and views regarding anxiety in acute settings, particularly in the perioperative environment at Perth Children’s Hospital through semi structured, 30 minute interviews with a member of the research team.
Timepoint [3] 333153 0
In the post operative time period (within hours and days after surgery but no later than 1 month after surgery).
Secondary outcome [1] 415991 0
To identify key themes related to volunteer's lived experiences of and views regarding anxiety in acute settings, particularly in the perioperative environment at Perth Children’s Hospital through semi structured, 30 minute interviews with a member of the research team.
Timepoint [1] 415991 0
Within a week of the volunteer's last shift in the perioperative setting.
Secondary outcome [2] 416310 0
Child healthcare literacy will be determined for all recruited participants using the HLS-Child-Q15 tool. HLS=Health Literacy Score
Timepoint [2] 416310 0
At the time of enrolment prior to interview.
Secondary outcome [3] 416311 0
Parent healthcare literacy will be determined for all recruited participants using the Newest Vital Sign.
Timepoint [3] 416311 0
At the time of enrolment prior to interview.

Eligibility
Key inclusion criteria
Children and parents will be recruited at Perth Children’s Hospital from the Surgical Short Stay Unit post-operative area.

Volunteers and staff including medical doctors (anaesthetists), anaesthetic technicians and nurses who work in the peri-operative environment will be invited to participate via email.

• Children aged 4 to 11 years and/or their parents will be included who have undergone anaesthesia for an elective surgical procedure.
• Volunteers and staff including anaesthetists, anaesthetic technicians and nurses involved in the perioperative care of children.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children and/or 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
Recruitment will conclude once data saturation is achieved. Data saturation is the point whereby no new themes can be identified and will be decided via consensus among the research team. The expected number of participants is 20 parents/carers, 20 staff members/volunteers and 20 children as 20 is typically large enough for data saturation to occur. Child participants will be stratified into three age groups: 4-6 years old, >6-9 years old and >9-11 years old with at least 6 participants in each stratum to ensure age group representation. We will recruit at least 5 nurses, 5 anaesthetic technicians and 5 medical doctors for the staff group, and at least 2 volunteers.

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. The Framework method has been chosen as it is useful for research teams that have varying levels of experience with qualitative research (with multiple analysts) as it provides a structured approach to analysis. Themes will be derived from the data.

Trustworthiness
• An interview guide will be used to conduct each interview. Researchers will be trained to correctly administer semi-structured interviews.
• Transcribed interview notes will be returned to participants for comment
• All demographic and literacy information will be removed prior to thematic analysis.
• Analyst triangulation will be used during the coding process to ensure multiple interpretations are captured and discussed, thereby increasing the richness of the findings, and establishing credibility and confirmability of findings.
• An audit trail will be used to document decisions made regarding the development of the analytical framework to provide transparency which establishes credibility and dependability of the conduct of this study.
Thick descriptions will be used to describe our findings, establishing some means of transferability of our findings, and negative cases will be identified and discussed.
• Results will be reported in line with COREQ consolidated criteria for reporting qualitative research.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2022
Actual
7/12/2022
Date of last participant enrolment
Anticipated
27/05/2024
Actual
24/03/2023
Date of last data collection
Anticipated
31/05/2024
Actual
24/03/2023
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23491 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 38898 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312551 0
Hospital
Name [1] 312551 0
Perth Children's Hospital
Country [1] 312551 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 314153 0
None
Name [1] 314153 0
Address [1] 314153 0
Country [1] 314153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311878 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 311878 0
Child and Adolescent Health Service Human Research Ethics Committee
15 Hospital Avenue
Nedlands
Western Australia 6009
Ethics committee country [1] 311878 0
Australia
Date submitted for ethics approval [1] 311878 0
20/09/2022
Approval date [1] 311878 0
20/10/2022
Ethics approval number [1] 311878 0
RGS0000005711

Summary
Brief summary
Millions of children undergo anaesthesia for surgical procedures around the world every year. Medical encounters can be an anxiety inducing experience for children, particularly when invasive procedures are performed, as happens for anaesthetic induction. Children can find the induction experience unpleasant because they are in an unfamiliar environment, with unfamiliar people and/or they have an aversion to needles or because they may find the anaesthetic gas mask intrusive and frightening.

Preoperative anxiety is a common and unfavourable manifestation in children and has been reported in 50 – 80% of children and can be characterised by feelings of apprehension, tension and worry and can stem from reasons including fear of the unknown, anticipation of separation from parents, fear of potential pain and fear of loss of control.

High levels of preoperative anxiety are associated with both physiological and psychological adverse outcomes in children such as significantly higher postoperative pain, increased anaesthetic use, a higher incidence of emergence delirium, prolonged recovery, and lengthened hospitalisations. These outcomes have detrimental effects on patients. Moreover, negative postoperative impacts of preoperative anxiety include maladaptive behaviours, such as nightmares, separation anxiety, increased fear of doctors and eating disorders.

Pharmacological interventions are currently the most common approach used to manage preoperative anxiety. However, there are some limitations to this method. Virtual-reality and video-based technology has been demonstrated to be acceptable and effective in minimising anxiety through both acting as a distraction and as an interactive means to acclimatise to the perioperative setting.
Paediatric anaesthetists often use distraction techniques such as conversation or humour to mediate anxiety. Maintaining parental presence during the induction of anaesthesia is another regularly used approach to help support paediatric patients. These social support methods have their benefits and challenges, but with limited overall anxiolysis.
The objectives of this project are to identify key themes related to children’s, parent’s, staff and volunteer lived experiences of and views regarding anxiety in acute settings, particularly in the perioperative environment at Perth Children’s Hospital.
The ANTELOPE study will improve our understanding of children’s’ anxiety in the perioperative setting to inform the adaptation and implementation of the perioperative Magic Coat program for use at Perth Children’s Hospital.
Trial website
Trial related presentations / publications
Public notes
We are undertaking a program with the Magic Coat Foundation aimed at positively reframing hospital experiences to reduce perioperative anxiety. The Magic Coat is a cognitive behaviour tool that has been developed to help children feel safe and manage their emotions. We will work to adapt the Magic Coat program for the perioperative environment. The aim is to empower children with the ability to communicate fears and anxieties and effectively mobilise skills to reduce the impact of these on their lives in the short term, and, with positive reinforcement, over the longer term and into adulthood.

Contacts
Principal investigator
Name 122694 0
Prof Britta von Ungern-Sternberg
Address 122694 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122694 0
Australia
Phone 122694 0
+61 420790101
Fax 122694 0
Email 122694 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for public queries
Name 122695 0
Prof Britta von Ungern-Sternberg
Address 122695 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122695 0
Australia
Phone 122695 0
+61 420790101
Fax 122695 0
Email 122695 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for scientific queries
Name 122696 0
Prof Britta von Ungern-Sternberg
Address 122696 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122696 0
Australia
Phone 122696 0
+61 420790101
Fax 122696 0
Email 122696 0
Britta.Regli-VonUngern@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Team have decided on this process


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.