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Trial registered on ANZCTR


Registration number
ACTRN12618001776291p
Ethics application status
Not yet submitted
Date submitted
23/10/2018
Date registered
29/10/2018
Date last updated
29/10/2018
Date data sharing statement initially provided
29/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Women's experiences of using Virtual Reality in labour.
Scientific title
Women's experiences of using Virtual Reality in labour and the effect of Virtual Reality on the experience of labour pain.
Secondary ID [1] 296398 0
Nil known
Universal Trial Number (UTN)
U1111-1222-6544
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour pain 310146 0
Anxiety in labour 310147 0
Condition category
Condition code
Alternative and Complementary Medicine 308896 308896 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 308897 308897 0 0
Normal pregnancy
Reproductive Health and Childbirth 308898 308898 0 0
Childbirth and postnatal care
Mental Health 308918 308918 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Virtual Reality technology via a headset. The headset is wireless. Participants can easily put it on themselves. You put it on like glasses with elasticised straps similar to a helmet. It is immersive, participants cannot see peripherally, only what they see in the goggles. Software consists of a range of Virtual Reality scenes, relaxation scenes comprising tropical beach scenes, waterfalls, the universe and solar system, forest scenes. with natural sounds. The project aims to conduct a feasibility study with women who are 35 weeks and over pregnant , inviting participants to try out four-six Virtual Reality scenes via the headset. Each scene lasts a maximum of 15-20 minutes. When these women go into labour, the next stage of the project invites these women to use the Virtual Reality technology in their labour, at any stage of labour they choose, for how often throughout their labour they choose and for how long they choose to wear the device. The minimum duration of use of this intervention in labour would be 10mins and the maximum duration 30 minutes. In terms of frequency of use the suggested frequency would be 2-4 times during labour. The intervention is in addition to standard care. Subjective and objective (physiological) measures of pain intensity will be recorded pre-intervention, during intervention and post-intervention. The researcher who is a professional midwife with 18 years experience will deliver the intervention. The intervention will be delivered face-to-face individually to each women when in labour. The location is where the women chooses to give birth either at home, in a midwife-led birthing unit or a tertiary maternity unit.
Intervention code [1] 312728 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307864 0
Pain intensity score as Assessed by Verbal Rating Scale
Timepoint [1] 307864 0
10 minutes (primary timepoint) and 15 minutes post intervention
Primary outcome [2] 307865 0
Maternal heart rate as assessed by electronic machine with saturation probe to measure heart rate
This is a surrogate measure for objective pain
Timepoint [2] 307865 0
10 minutes (primary timepoint) and 15 minutes post intervention
Primary outcome [3] 307866 0
Maternal blood pressure as assessed by electronic blood pressure machine
This is a surrogate measure for objective pain
Timepoint [3] 307866 0
10 minutes (primary timepoint) and 15 minutes post intervention
Secondary outcome [1] 353221 0
Feasibility of intervention assessed by conducting interviews post intervention with women in antenatal period
Instrument used is a series of open-ended questions designed specifically for this study
Timepoint [1] 353221 0
1 hr after intervention
Secondary outcome [2] 353222 0
Exploration of women's experiences using the intervention post birth
Instrument used is an open-ended question designed specifically for this study
Timepoint [2] 353222 0
2-3 days postnatally
Secondary outcome [3] 353277 0
Acceptability of intervention assessed by conducting interviews post intervention with women in antenatal period
Instrument used is a series of open-ended questions designed specifically for this study
Timepoint [3] 353277 0
1 hr after using intervention

Eligibility
Key inclusion criteria
Nulliparous or multiparous
35 weeks pregnant and over
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No history of seizures
No vision or hearing deficits
No history of psychiatric disturbances
No history of severe nausea
No predisposition to motion sickness
English as a second language requiring the use of an interpreter

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Single group
Other design features
Participants all receive same intervention but at different times, different duration. When not using the intervention they receive standard care in labour. They act as their own controls.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
One-sided paired sample t-test to compare the physiological measures pre-intervention to during intervention and during intervention to post-intervention. In terms of the subjective measurement of pain scores using the Verbal Rating Scale - one-sided paired sample t-tests. With subjective measurement of pain scores I will report the number of women as a percent that reported a decrease in pain and provide a 95% confidence interval.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 20947 0
New Zealand
State/province [1] 20947 0
Wellington

Funding & Sponsors
Funding source category [1] 301006 0
University
Name [1] 301006 0
Victoria University of Wellington
Address [1] 301006 0
Graduate School of Nursing, Midwifery and Health
Level 7
Clinical Services Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country [1] 301006 0
New Zealand
Primary sponsor type
Individual
Name
Lorna Massov
Address
Victoria University
Graduate School of Nursing, Midwifery and Health
Level 7
Clinical Services Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 300594 0
Individual
Name [1] 300594 0
Dr Brian Robinson
Address [1] 300594 0
Victoria University
Graduate School of Nursing, Midwifery and Health
Level 7
Clinical Services Block
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country [1] 300594 0
New Zealand
Secondary sponsor category [2] 300595 0
University
Name [2] 300595 0
Victoria University of Wellington
Address [2] 300595 0
Victoria University
Graduate School of Nursing, Midwifery and Health
Level 7
Clinical Services Block
Wellington Regional Hospital
Riddiford Street
Wellington 6021
Country [2] 300595 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301762 0
Health and Disability Committee
Ethics committee address [1] 301762 0
Technology One House
Level 11/86 Victoria Street
Wellington 6011
Ethics committee country [1] 301762 0
New Zealand
Date submitted for ethics approval [1] 301762 0
30/10/2018
Approval date [1] 301762 0
Ethics approval number [1] 301762 0

Summary
Brief summary
The purpose of this mixed methods research study will be to explore the experiences of a small group of women using Virtual Reality as a non-pharmacological method of pain relief in labour and to discover whether Virtual Reality has an effect on the experience of labour pain for women. To gather data an initial feasibility study will be conducted. Interviews with 10 pregnant women will be conducted to assess acceptability and feasibility of the use of Virtual Reality and a range of Virtual Reality environments. Further data will be collected in the form of objective (physiological) and subjective measures of pain intensity before, during and after using Virtual Reality in labour. In the final phase of data gathering, interviews will be conducted post-birth with the 10 women. The interviews will be transcribed and analysed phenomenologically.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3190 3190 0 0
http://www.anzctr.org.au/AnzctrAttachments/376240-information sheet.doc (Participant information/consent)
Attachments [2] 3191 3191 0 0

Contacts
Principal investigator
Name 88018 0
Ms Lorna Massov
Address 88018 0
Victoria University
Graduate School of Nursing, Midwifery and Health
Level 7
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country 88018 0
New Zealand
Phone 88018 0
+64 027 2271 492
Fax 88018 0
Email 88018 0
lorna.massov@vuw.ac.nz
Contact person for public queries
Name 88019 0
Ms Lorna Massov
Address 88019 0
Victoria University
Graduate School of Nursing, Midwifery and Health
Level 7
Clinical Services Building
Wellington Regional Hospital
Newton
Wellington 6021
Country 88019 0
New Zealand
Phone 88019 0
+64 027 2271 492
Fax 88019 0
Email 88019 0
lorna.massov@vuw.ac.nz
Contact person for scientific queries
Name 88020 0
Ms Lorna Massov
Address 88020 0
Victoria University
Graduate School of Nursing, Midwifery and Health
Level 7
Clinical Services Building
Wellington Regional Hospital
Riddiford Street
Newtown
Hataitai
Wellington 6021
Country 88020 0
New Zealand
Phone 88020 0
+64 027 2271 492
Fax 88020 0
Email 88020 0
lorna.massov@vuw.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
To achieve aims in proposed proposal
By what mechanism will data be made available?
Subject to approval by Principal Investigator
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Other
'Other' documents specified
Questions relating to feasibility and acceptability study and post natal data gathering
Attachments/websites
Type [1] 8 0
Study protocol
URL/details/comments [1] 8 0
Attachment [1] 8 0
Type [2] 20 0
Informed consent form
URL/details/comments [2] 20 0
Type [3] 21 0
Other
URL/details/comments [3] 21 0
Questions for data gathering
Summary results
Not applicable