Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12620000590965
Ethics application status
Approved
Date submitted
19/05/2020
Date registered
21/05/2020
Date last updated
4/09/2020
Date data sharing statement initially provided
21/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychological impact of COVID-19 pandemic on perioperative staff at the Royal Melbourne Hospital – a longitudinal study
Scientific title
Psychological impact of COVID-19 pandemic on perioperative staff at the Royal Melbourne Hospital – a longitudinal study
Secondary ID [1] 301319 0
Nil Known
Universal Trial Number (UTN)
U1111-1252-2057
Trial acronym
PICOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological health 317510 0
Condition category
Condition code
Mental Health 315608 315608 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study uses a time-series survey, repeating every 4 weeks until the end of the COVID-19 pandemic or for 8 months from commencement, whichever is the sooner. The survey will open for one week at each time point. Each online survey should take less than 15 minutes to fill out. This allows ongoing evaluation of the psychological impact on perioperative staff over the course of the COVID-19 pandemic.

Participation in this project is voluntary. If participants do not wish to participate or to continue to participate in this project, they can simply ignore the email invitation and do not complete the survey questionnaires.
Intervention code [1] 317616 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323843 0
To evaluate the psychological impact of COVID-19 on perioperative staff by using a set of repeat survey questionnaires during the pandemic period. We use a combination of measurement tools as listed below in our secondary outcome section. They include GAD-7, PHQ-9, PC-PTSD-5, IES-R-22, AMBI-9 and a few qualitative questions.
Timepoint [1] 323843 0
Every 4 weeks during the COVID-19 pandemic up to a maximum of 8 months
Secondary outcome [1] 383045 0
GAD-7 Score (General anxiety disorder)
Timepoint [1] 383045 0
every 4 weeks during the COVID-19 pandemic up to a maximum of 8 weeks
Secondary outcome [2] 383046 0
PHQ-9 Score (Patient health questionnaires)
Timepoint [2] 383046 0
every 4 weeks during the COVID-19 pandemic up to a maximum of 8 weeks
Secondary outcome [3] 383047 0
PC-PTSD-5 scores (Post-traumatic stress disorder)
Timepoint [3] 383047 0
every 4 weeks during the COVID-19 pandemic up to a maximum of 8 weeks
Secondary outcome [4] 383048 0
Qualitative questionnaires were designed specifically for this study. Qualitative responses will be analysed using thematic analysis with a focus on understanding participants’ experiences within and across the various subgroups.
Timepoint [4] 383048 0
every 4 weeks during the COVID-19 pandemic up to a maximum of 8 weeks
Secondary outcome [5] 383061 0
IES-R-22 (Impact of event scale - revised)
Timepoint [5] 383061 0
At the end of pandemic or the 8th month since commencement of study (whichever is sooner)
Secondary outcome [6] 383062 0
AMBI-9 (Abbreviated Maslach Burnout Inventory)
Timepoint [6] 383062 0
At the end of pandemic or the 8th month since commencement of study (whichever is sooner)

Eligibility
Key inclusion criteria
Perioperative staff working at the Royal Melbourne Hospital during the COVID-19 pandemic. This includes anaesthetic consultants, surgical consultants, anaesthetic trainees, surgical trainees, anaesthetic nurses, scrub nurses and technicians.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not applicable

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
There are around 300 peri-operative staff members at the Royal Melbourne Hospital. Assuming the participation rate to be 20-30%, we estimate that there will be about 60-90 participants for this study.

The primary outcome of the study is to evaluate the impact of psychological impact of COVID-19 on our perioperative staff. Maharaj’s study (Int J Environ Res Public Health. 2019 Jan; 16: 61.) shows that the prevalence of depression among nurses is about 30%. According to Lai’s study (JAMA Netw Open. 2020;3(3):e203976. doi:10.1001/jamanetworkopen.2020.3976), 60% of the frontline workers suffer from depressive symptoms during the COVID-19 pandemic. Therefore, if we assume the proportion of peri-operative staff who suffers from depressive symptoms changes from 30% to 60% due to pandemic, then we need about 64 participants to observe this significant difference, with power of 0.8. Similarly, about 50-60% of frontline workers suffer from anxiety and distress symptoms during the pandemic in Lai’s study. Our power calculation would be adequate to detect the change of baseline rate from 30% or lower. There are around 300 peri-operative staff members at the Royal Melbourne Hospital. Assuming the participation rate to be 20-30%, we estimate that there will be about 60-90 participants for this study. This will be adequate to show the calculated significant difference.

Descriptive analyses will be used to describe the characteristics of the sample. Unpaired t-test or Wilcoxon rank-sum test will be used to evaluate the median or mean score of each assessment tool (GAD-7, PHQ-9 and PC-PTSD) across time, depending on the normality of the distribution. Multiple regression models will be used to examine risk factors associated with worsening psychological outcomes (GAD-7, PHQ-9, PC-PTSD, IES-R-22 and A-MBI-9 scores) at each discrete time interval. The effect size of the co-variates will be compared across time. We will also categorize the degree of each psychological outcomes: PHQ-9: normal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27) depression; GAD-7: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety; PC-PTSD-5: <3 no PTSD, =3 probable PTSD; IES-R, normal (0-8), mild (9-25), moderate (26-43), and severe (44-88) distress. Chi square test will be used to analyze the correlation between the categorical outcomes and the baseline variables. A p value of <0.05 is considered statistically significant.

Depending on the number of drop-outs with time, a sub-analysis with repeated measures will be performed. Any change in the category of each of the psychological test across time (e.g. from mild to moderate depression) will be considered as worsening outcome. We will also compare the average lowest score and the average highest score for each psychological test. Paired t-test or Wilcoxon sign rank test will be used to test for statistical significance depending on the normality of the data. Qualitative responses will be analysed using thematic analysis with a focus on understanding participants’ experiences within and across the various subgroups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
26/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
104
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16704 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 30303 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 305755 0
Hospital
Name [1] 305755 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital
Country [1] 305755 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
300 Grattan Street
Parkville
Vic 3050
Country
Australia
Secondary sponsor category [1] 306190 0
None
Name [1] 306190 0
Address [1] 306190 0
Country [1] 306190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306028 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 306028 0
Office for Research
CITY CAMPUS
Royal Melbourne Hospital,
Level 2 South West,
300 Grattan Street,
Parkville Victoria
3050.
Ethics committee country [1] 306028 0
Australia
Date submitted for ethics approval [1] 306028 0
27/04/2020
Approval date [1] 306028 0
22/05/2020
Ethics approval number [1] 306028 0

Summary
Brief summary
This study will investigate the psychological impact on healthcare workers who work in the operating theatre environment during the COVID-19 pandemic. This is an important study because operating theatre staff are frontline healthcare professionals, who are working under enormous pressure during this challenging time. There is potentially a significant risk of mental health burden as a result of the pandemic. This study will help to identify any risk factors which may be associated with worse psychological outcomes.
This study is a time-series online survey. Participation is voluntary. Data collected are anonymous and unidentifiable. The survey will be repeated every 4 weeks until the end of the pandemic or for 8 months from commencement, whichever is the sooner. Psychological support strategies will be provided to each individual at the end of each survey in the form of written information.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102474 0
Dr Irene Ng
Address 102474 0
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
300 Grattan Street
Parkville
Victoria 3050
Country 102474 0
Australia
Phone 102474 0
+61 03 9342 7000
Fax 102474 0
Email 102474 0
[email protected]
Contact person for public queries
Name 102475 0
Irene Ng
Address 102475 0
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
300 Grattan Street
Parkville
Victoria 3050
Country 102475 0
Australia
Phone 102475 0
+61 03 9342 7000
Fax 102475 0
Email 102475 0
[email protected]
Contact person for scientific queries
Name 102476 0
Irene Ng
Address 102476 0
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
300 Grattan Street
Parkville
Victoria 3050
Country 102476 0
Australia
Phone 102476 0
+61 03 9342 7000
Fax 102476 0
Email 102476 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
To maintain participants' confidentiality


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.