Can viewing a virtual reality video as part of preoperative information reduce anxiety before a caesarean section?

ISRCTN	ISRCTN74794447
DOI	https://doi.org/10.1186/ISRCTN74794447
Protocol serial number	N17.017
Sponsor	Máxima Medical Centre
Funder	Máxima Medical Centre

Submission date: 05/11/2019
Registration date: 05/11/2019
Last edited: 19/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The aim of this study is to investigate whether adding a virtual reality video to standard preoperative information before a caesarean delivery reduces anxiety in patients and their partners.

Who can participate?
Women older than 18 with a term pregnancy, scheduled for a caesarean delivery

What does the study involve?
Participants are randomly allocated to either the virtual reality group or the control group. The latter only receives standard preoperative information. Patients in the VR group receive a short virtual reality video which shows all aspects of the caesarean delivery.

What are the possible benefits and risks of participating?
Women who are allocated to the VR group receive additional pre-operative information. There is a risk of motion sickness after watching the VR video, but this risk is minimal.

Where is the study run from?
Máxima Medical Centre Veldhoven (Netherlands)

When is the study starting and how long is it expected to run for?
November 2016 to January 2018

Who is funding the study?
Máxima Medical Centre Veldhoven (Netherlands)

Who is the main contact?
Lore Noben
Lore.noben@mmc.nl

Contact information

Ms Lore Noben
Scientific

PO Box 7777
Veldhoven
5500 MB
Netherlands

ORCID ID	0000-0002-4894-0873
Phone	+31 (0)40 888 8384
Email	Lore.noben@mmc.nl

Study information

Primary study design	Interventional
Study design	Single-centre randomized controlled trial.
Secondary study design	Randomised controlled trial
Scientific title	A virtual reality video to improve INFOrmation provision and to reduce anxiety before a Caesarean delivery: INFO-C trial
Study acronym	INFO-C
Study objectives	Adding the virtual reality (VR) video to standard preoperative information causes a significant decrease in preoperative anxiety. Furthermore, we expected a positive effect of VR on levels of anxiety and patient satisfaction scores of both women and their partners. Third, this study was conducted to check whether VR would be feasible to implement without causing any harming side effects such as motion sickness.
Ethics approval(s)	On 15/06/2015 the researchers received a statement from their local institutional review board that no ethics approval was required (METC Máxima MC, PO Box 7777, 5500 MB Veldhoven, De Run 4600, 5504 DB Veldhoven; Tel: +31 (0)40 888 95 28; Email: metc@mmc.nl), N17.017
Health condition(s) or problem(s) studied	Preoperative anxiety
Intervention	The intervention comprised a 360° virtual reality video, in addition to standard preoperative information. The control group only received standard preoperative information. Randomization was performed using an online computer randomizer by means of stratified block randomization. Stratification was done based on history of emergency caesarean delivery (yes or no).
Intervention type	Other
Primary outcome measure(s)	Anxiety measured using the Visual Analogue scale for anxiety (VAS-A) at the time of inclusion and at admittance on the ward
Key secondary outcome measure(s)	1. Patient satisfaction measured by means of questionnaires and filled in 1 to 2 weeks after the caesarean delivery 2. Motion sickness assessed using simulation sickness questionnaire filled in by participants from the VR group immediately after watching the VR video
Completion date	31/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	80
Total final enrolment	97
Key inclusion criteria	1. Women over the age of 18 2. Planned for a primary caesarean delivery 3. No history of caesarean delivery or history of an emergency caesarean delivery 4. Gestational age above 37 weeks
Key exclusion criteria	1. A history of a primary caesarean delivery 2. Insufficient understanding of the Dutch language 3. Prematurity (gestational age below 37 weeks) 4. Placenta praevia 5. Pre-eclampsia 6. Suspected congenital anomaly
Date of first enrolment	11/11/2016
Date of final enrolment	28/12/2017

Locations

Countries of recruitment

Netherlands

Study participating centre

Máxima Medical Centre

P.O. box 7777
Veldhoven
5500MB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Lore Noben (lore.noben@mmc.nl).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/12/2019	19/12/2019	Yes	No

Editorial Notes

19/12/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
05/11/2019: Trial's existence confirmed by ethics committee.