ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12622001498785

Ethics application status

Approved

Date submitted

18/11/2022

Date registered

29/11/2022

Date last updated

15/09/2024

Date data sharing statement initially provided

29/11/2022

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]

Nil

Universal Trial Number (UTN)

Trial acronym

ANTELOPE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Elective surgery

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Mental Health

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

In the post operative time period (within hours and days after surgery but no later than 1 month after surgery).

Primary outcome [2]

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]

In the post operative time period (within hours and days after surgery but no later than 1 month after surgery).

Primary outcome [3]

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]

In the post operative time period (within hours and days after surgery but no later than 1 month after surgery).

Secondary outcome [1]

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]

Within a week of the volunteer's last shift in the perioperative setting.

Secondary outcome [2]

Child healthcare literacy will be determined for all recruited participants using the HLS-Child-Q15 tool. HLS=Health Literacy Score

Timepoint [2]

At the time of enrolment prior to interview.

Secondary outcome [3]

Parent healthcare literacy will be determined for all recruited participants using the Newest Vital Sign.

Timepoint [3]

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

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]

Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Stan Perron Charitable Foundation

Address [2]

Country [2]

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]

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]

Child and Adolescent Health Service Human Research Ethics Committee
15 Hospital Avenue
Nedlands
Western Australia 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/09/2022

Approval date [1]

20/10/2022

Ethics approval number [1]

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

Prof Britta von Ungern-Sternberg

Address

Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009

Country

Australia

Phone

+61 420790101

Fax

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

Contact person for public queries

Name

Britta von Ungern-Sternberg

Address

Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009

Country

Australia

Phone

+61 420790101

Fax

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

Contact person for scientific queries

Name

Britta von Ungern-Sternberg

Address

Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009

Country

Australia

Phone

+61 420790101

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

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically