Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000306617p
Ethics application status
Submitted, not yet approved
Date submitted
27/02/2023
Date registered
20/03/2023
Date last updated
20/03/2023
Date data sharing statement initially provided
20/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
STress Responses Amongst Undergraduates and Surgeons performing Surgical tasks: A cross-over study on the effect of background music during surgical tasks (STRAUSS)
Scientific title
STress Responses Amongst Undergraduates and Surgeons performing Surgical tasks: A cross-over study on the effect of background music during surgical tasks (STRAUSS)
Secondary ID [1] 309087 0
nil known
Universal Trial Number (UTN)
U1111 1288-7255
Trial acronym
STRAUSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgeon Stress 329159 0
Condition category
Condition code
Surgery 326133 326133 0 0
Surgical techniques
Mental Health 326193 326193 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Determine the influence of background music on physiological parameters (sympathetic nervous activity, peripheral and central chemoreflex responses, ventilatory responses, cerebral blood flow) and psychological parameters (taskload and anxiety scores) in surgeons (experienced and inexperienced) while performing simulated surgical tasks

Participants will wear noise-cancelling headphones containing music the music or control condition while performing tasks. They will perform the tasks on their own.

The task will be a fine suturing activity, and participants will complete this 10minute task 4 times, with 10 minute breaks between periods. The task will simulate a carotid patchplasty.
This will occur after a training period. The total session will be estimated to take 2 hours which will include the training period..

Music will be a self-selected playlist by the participant and started/connected by the research team at a volume selected by the surgeon.
The study will be terminated if the surgeon is unable to tolerate the music intervention, though this is expected to be very unlikely.
Intervention code [1] 325534 0
Behaviour
Comparator / control treatment
Ambient theatre noise - this will be pre-recorded theatre ambient noise played at a low volume. This will be played through the same noise cancelling headphones as the theatre music.
Control group
Active

Outcomes
Primary outcome [1] 333997 0
Heart rate and variability

Heart rate will be measured using standard electrocardiogram involving the placement of several sticky patch electrodes on the collarbones and chest

Timepoint [1] 333997 0
continuously during the study period and break periods
Primary outcome [2] 334068 0
Surgical Taskload by form of questionnaire
Timepoint [2] 334068 0
At the completion of each of the surgical task periods and once at baseline (total 5 times)
Primary outcome [3] 334069 0
blood pressure

Brachial BP will be measured with a clinically validated automated sphygmomanometer (Omron), using a cuff wrapped around the upper arm.
Timepoint [3] 334069 0
continuously during the study period and break periods
Secondary outcome [1] 419264 0
Cerebral Blood Flow

Brain blood flow of the left middle cerebral artery will be measured using a transcranial Doppler ultrasound probe, via the temporal ‘windows’ in front of the ear and above the zygomatic arc, respectively. After optimal signals are obtained, probes will be fixed in place using an adjustable headband and small amount of ultrasound gel. These measures will provide an estimate of mean cerebral blood velocity (Vmean).
Timepoint [1] 419264 0
continuously during the study period and break periods
Secondary outcome [2] 419265 0
Anxiety inventory scores
Timepoint [2] 419265 0
At the completion of each of the surgical task periods and once at baseline (total 5 times)
Secondary outcome [3] 419515 0
Ventilatory response - respiratory rate

Participants will wear a mouthpiece/noseclip or oronasal mask (Hans Rudolph) attached to a heated pneumotachograph connected to a differential pressure transducer to measure bidirectional airflow (Hans Rudolph). Ports will allow the measurement of the percentage of CO2 and O2 (ADInstruments) in the expirate.

Timepoint [3] 419515 0
continuously during the study period and break periods
Secondary outcome [4] 419516 0
Ventilatory responses - respiratory volumes

Participants will wear a mouthpiece/noseclip or oronasal mask (Hans Rudolph) attached to a heated pneumotachograph connected to a differential pressure transducer to measure bidirectional airflow (Hans Rudolph). Ports will allow the measurement of the percentage of CO2 and O2 (ADInstruments) in the expirate.

Timepoint [4] 419516 0
continuously during the study period and break periods
Secondary outcome [5] 419517 0
Ventilatory responses (end-tidal CO2)

Participants will wear a mouthpiece/noseclip or oronasal mask (Hans Rudolph) attached to a heated pneumotachograph connected to a differential pressure transducer to measure bidirectional airflow (Hans Rudolph). Ports will allow the measurement of the percentage of CO2 and O2 (ADInstruments) in the expirate.

Timepoint [5] 419517 0
continuously during the study period and break periods
Secondary outcome [6] 419518 0
Performance measures – time to completion, measured using a stopwatch at the time
Timepoint [6] 419518 0
On completion of task
Secondary outcome [7] 419519 0
Performance measures – subjective self-assessment of work by Global Rating Scale and Objective Surgical Assessment Tool Questionnaires
Timepoint [7] 419519 0
On completion of task
Secondary outcome [8] 419520 0
Performance measures - photographs will be taken of the product of the surgical task (patch plasty suture line) - and objective assessment of photographs by blinded assessors.
Timepoint [8] 419520 0
On completion of task

Eligibility
Key inclusion criteria
• Qualified or training surgeons from any surgical sub-specialty
• Inexperienced operators (clinical medical students)
• Men and women;
• Aged over 18 years;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

• Significant physical impairment that inhibits completion of dextrous tasks
• Current pregnancy
• Significant arrhythmias (e.g., atrial fibrillation, previous VT / significant ventricular ectopy)
• Hemodynamically significant valvular heart disease (e.g., stenosis, mechanical valve replacement)
• Severe left ventricular systolic dysfunction
• Recent acute coronary syndrome (<12 months) (e.g., MI, angioplasty, unstable angina)
• Recent stroke/TIA (<12 months)
• Inability to fully or appropriately provide consent (e.g., language issue, reading capability)
• Underlying medical conditions, which in the opinion of the Investigator place the participant at unacceptably high risk for participating in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a crossover study - participants will be subject to two periods of each condition - participant allocation concealment is by form of block randomisation - with participant only finding out under which condition each of four activity periods will be in - until they begin the task
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator - block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Anthropometric (e.g., BMI) and demographic (e.g., age) information gathered at primary screening will be quantified using basic statistics (mean, SD, Median, IQR) and graphical presentations (boxplots, histograms, scatter plots). Likewise levels of primary and secondary outcomes will be similarly reported. Normal distribution will be evaluated using Shapiro-Wilk tests. Comparisons of normally distributed physiological variables between groups will be made using a t-test, and non-normally distributed data evaluated using a Mann–Whitney U test. In the event of potential confounding differences in baseline characteristics, analysis of covariance (ANCOVA) will be employed. Statistical analysis will performed using SPSS (IBM). Significance will be set at p < 0.05. Normally distributed data will be presented as mean (SD) while non-normally distributed data will be presented as median [interquartile range].


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25289 0
New Zealand
State/province [1] 25289 0
Auckland

Funding & Sponsors
Funding source category [1] 313293 0
Charities/Societies/Foundations
Name [1] 313293 0
Royal Australasian College of Surgeons
Country [1] 313293 0
New Zealand
Primary sponsor type
Individual
Name
Dr Anantha Narayanan
Address
University of Auckland,
Grafton Campus
85 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 315084 0
None
Name [1] 315084 0
Address [1] 315084 0
Country [1] 315084 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312520 0
Health and Disabilities Ethics Committee (NZ)
Ethics committee address [1] 312520 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 312520 0
New Zealand
Date submitted for ethics approval [1] 312520 0
07/03/2023
Approval date [1] 312520 0
Ethics approval number [1] 312520 0

Summary
Brief summary
In this study, we aim to answer the research question "While operating, do surgeons experience a physiological (autonomic) stress and psychological stress which is affected by the presence of background music?". We will do this by recruiting experienced and inexperienced operators to a randomised Non-blinded Crossover Trial in a simulated environment. Participants will perform surgical tasks under the music and the no music conditions, and we will measure physiological and psychological markers of stress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124954 0
Dr Anantha Narayanan
Address 124954 0
Department of Surgery
University of Auckland
Grafton Campus
85 Park Road, Grafton, Auckland 1023
Country 124954 0
New Zealand
Phone 124954 0
+64276880384
Fax 124954 0
Email 124954 0
[email protected]
Contact person for public queries
Name 124955 0
Dr Anantha Narayanan
Address 124955 0
Department of Surgery
University of Auckland
Grafton Campus
85 Park Road, Grafton, Auckland 1023
Country 124955 0
New Zealand
Phone 124955 0
+64276880384
Fax 124955 0
Email 124955 0
[email protected]
Contact person for scientific queries
Name 124956 0
Dr Anantha Narayanan
Address 124956 0
Department of Surgery
University of Auckland
Grafton Campus
85 Park Road, Grafton, Auckland 1023
Country 124956 0
New Zealand
Phone 124956 0
+64276880384
Fax 124956 0
Email 124956 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18452Study protocol    385474-(Uploaded-06-03-2023-19-47-33)-Study-related document.docx



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.