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Trial registered on ANZCTR


Registration number
ACTRN12618001004257
Ethics application status
Approved
Date submitted
6/06/2018
Date registered
14/06/2018
Date last updated
20/06/2019
Date data sharing statement initially provided
20/06/2019
Date results information initially provided
20/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of virtual reality on pain during a procedure of manually rotating a baby into the head down position during pregnancy.
Scientific title
Investigating the effect of virtual reality on pain during external cephalic version for women with breech pregnancy.
Secondary ID [1] 295104 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy - antenatal 308179 0
Pain 308180 0
Condition category
Condition code
Reproductive Health and Childbirth 307215 307215 0 0
Antenatal care
Anaesthesiology 307261 307261 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At present, standard protocols for the external cephalic version procedure do not involve the administration of analgesia. These protocols also recommend performance of this procedure after 37 weeks into the pregnancy.

For this study, commercially available virtual reality headsets (Samsung Gear VR) containing custom-designed content will be provided to individuals of the intervention group for the duration of the external cephalic version procedure (which is approximately 30 minutes) and as an adjunct to the standard care. To ensure adherence to the virtual reality headset, the trials will be performed under direct observation by a member of the research team and participants will be required to complete a post-procedure questionnaire.

The content that will be displayed on the virtual reality headset is called "Sky Lights". In Sky Lights, the user will find herself lying down in a quiet field, staring at a starry night sky with several unlit Chinese lanterns floating gently above her. By focusing her gaze on a lantern, she will be able to set it alight, making the spectacle more colourful as the lantern floats upwards and away. Occasionally, as a reward for her continued participation; a lit lantern will either set off a series of fireworks or form Lantern Festival shapes such as a dragon or a giant fish. This content is designed to last approximately 10 minutes.
Intervention code [1] 301441 0
Treatment: Devices
Intervention code [2] 301462 0
Treatment: Other
Comparator / control treatment
Participants in the control group will undergo the external cephalic version procedure under standard conditions which does not involve the administration of analgesia.
Control group
Active

Outcomes
Primary outcome [1] 306166 0
Pain scores assessed using a questionnaire designed specifically for the study.
Timepoint [1] 306166 0
Data is collected immediately at the end of each procedure.
Secondary outcome [1] 347757 0
An evaluation of any side effects as a result of the applied virtual reality technology and content. This will be determined through analysis of a questionnaire designed specifically for the study.

Known possible adverse reactions include nausea, motion sickness, loss of awareness, disorientation, and mild eye strain.
Timepoint [1] 347757 0
Data is collected immediately at the end of each procedure.
Secondary outcome [2] 347758 0
Composite outcome: Assessment of feedback about the quality of device experience. This will be determined through analysis of a questionnaire designed specifically for the study.
Timepoint [2] 347758 0
Data is collected immediately at the end of each procedure.
Secondary outcome [3] 347759 0
Evaluation of pre- and post-procedure heart rate of the mother. This will be determined through analysis of a questionnaire provided to the trial operator who will record data from monitoring equipment available in the clinic.
Timepoint [3] 347759 0
Recording of physiological parameters will be done pre- and post-procedure. Analysis of any variation will be performed when the data is collected at the end of the procedure.
Secondary outcome [4] 348099 0
Evaluation of pre- and post-procedure blood pressure of the mother. This will be determined through analysis of a questionnaire provided to the trial operator who will record data from monitoring equipment available in the clinic.
Timepoint [4] 348099 0
Recording of physiological parameters will be done pre- and post-procedure. Analysis of any variation will be performed when the data is collected at the end of the procedure.

Eligibility
Key inclusion criteria
* Patient must have a singleton pregnancy.
* Patient must have a breech pregnancy that has been confirmed by ultrasound prior to the procedure.
* Patient must have consented to an external cephalic version.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women below 18 years of age.
* Patients with a prior history of sensitivity to virtual reality technology, motion sickness, vertigo, seizures, epilepsy, active nausea, and vomiting.
* History of prior uterine surgery, uterine abnormalities, multiple pregnancy, contraindications to vaginal delivery, maternal cardiovascular disease, severe hypertension, ASA greater than 2 (suffer a “severe medical disease”, at minimum), pre-labour rupture of membranes, placental abruption, fetal anomaly, and intra-uterine fetal death.
* Patients with an intellectual or mental impairment.
* People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
* People highly dependent on medical care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11078 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 22889 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 299684 0
University
Name [1] 299684 0
Monash University
Address [1] 299684 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country [1] 299684 0
Australia
Primary sponsor type
University
Name
Monash University Department of Obstetrics and Gynaecology
Address
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 299025 0
Hospital
Name [1] 299025 0
Monash Health
Address [1] 299025 0
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country [1] 299025 0
Australia
Secondary sponsor category [2] 299063 0
Commercial sector/Industry
Name [2] 299063 0
Biorithm Pte. Ltd.
Address [2] 299063 0
93A Lorong Tanggam,
Singapore, 798775
Country [2] 299063 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300589 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 300589 0
Research Support Services,
Level 2, i Block,
Monash Medical Centre,
246 Clayton Road,
Clayton, VIC, 3168
Ethics committee country [1] 300589 0
Australia
Date submitted for ethics approval [1] 300589 0
16/05/2018
Approval date [1] 300589 0
04/07/2018
Ethics approval number [1] 300589 0
HREC/18/MonH/413

Summary
Brief summary
Introduction:
External cephalic version (ECV) is a procedure whereby a fetus is manually rotated, by applying pressure to the maternal abdomen, from a bottom/feet first position to the preferred head first position to enable safer vaginal delivery. Whilst safe and low-risk, it has been associated with moderate pain, in part, due to the lack of administered analgesia.

To address this, research groups around the world have experimented with various modalities of relief, including regional anaesthesia, hypnosis, and systemic opioids; but have not produced any conclusive demonstration of benefit to date. As such, there is a clinical gap in addressing pain during the procedure.

Virtual reality (VR) is a technological medium that is used to create simulated scenarios in which users are immersed and able to interact with through stimulation of the senses. In recent years, there has been a growing interest in medicine for its potential to provide pain relief. To date, positive results have been observed in patients requiring port access, venepuncture, chronic wound/burn dressing changes, and episiotomy. The mechanism responsible for this phenomenon is not yet fully understood, but is attributed to its ability to distract users from perceiving pain and also due to neurophysiological changes that result from long-term use.

Given the potential of VR to facilitate analgesia and the lack of effective pain relief during ECV, this study will function as a proof-of-concept to determine if VR technology can be used to reduce pain perception during this procedure.

Aims:
1) Investigate the effect of VR on:
* Pain scores during ECV.
* Physiological parameters during and after ECV.
2) Elicit patient opinion about using VR during the ECV procedure (ie. what do patients think?) and investigate potential side effects and their acceptability.

Participants:
In this study, 50 pregnant women will be recruited from the Breech Clinic at Monash Medical Centre. To be considered as an eligible participant, the women must fulfill the criteria outlined previously.

Methods:
Participants will be screened for inclusion into the study. They will then be randomly allocated to either, the control (no VR) group or the intervention (VR) group.

Immediately prior to the procedure, routine monitoring and tocolysis will be performed. The ECV will commence after and patients will receive either, routine care or routine care with VR intervention.

Post-procedure, vital signs will be evaluated. Questionnaires about pain perceived and device experience will also be provided.

Expected Outcomes:
A demonstrated potential for VR as an analgesic will be demonstrated by:
* Reduced pain scores in the intervention (VR) group.
* Minimal side effects.
* Positive feedback about the device and content.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84134 0
Dr Vinayak Smith
Address 84134 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 84134 0
Australia
Phone 84134 0
+61431330754
Fax 84134 0
Email 84134 0
vinayak.smith@monash.edu
Contact person for public queries
Name 84135 0
Dr Vinayak Smith
Address 84135 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 84135 0
Australia
Phone 84135 0
+61431330754
Fax 84135 0
Email 84135 0
vinayak.smith@monash.edu
Contact person for scientific queries
Name 84136 0
Prof Euan Morrison Wallace
Address 84136 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 84136 0
Australia
Phone 84136 0
+61335345145
Fax 84136 0
Email 84136 0
euan.wallace@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Protection of participant identity and data.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary