Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Ms Lore Noben
ORCID ID
https://orcid.org/0000-0002-4894-0873
Contact details
PO Box 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 888 8384
Lore.noben@mmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N17.017
Study information
Scientific title
A virtual reality video to improve INFOrmation provision and to reduce anxiety before a Caesarean delivery: INFO-C trial
Acronym
INFO-C
Study hypothesis
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
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
Study design
Single-centre randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Anxiety measured using the Visual Analogue scale for anxiety (VAS-A) at the time of inclusion and at admittance on the ward
Secondary outcome measures
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
Overall trial start date
01/11/2016
Overall trial end date
31/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Total final enrolment
97
Participant 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
Recruitment start date
11/11/2016
Recruitment end date
28/12/2017
Locations
Countries of recruitment
Netherlands
Trial participating centre
Máxima Medical Centre
P.O. box 7777
Veldhoven
5500MB
Netherlands
Sponsor information
Organisation
Máxima Medical Centre
Sponsor details
PO Box 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 888 8384
Lore.noben@mmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Máxima Medical Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication of the results in the Journal of Medical Internet Research (JMIR) Mental Health, accepted for publication.
L. Noben, S.M.T.A. Goossens, S.E.M. Truijens, M.M.G. van Berckel, C.W. Perquin, G.D. Slooter, S.J. van Rooijen. A virtual reality video to improve information provision and to reduce anxiety before a cesarean delivery: a randomized controlled trial. JMIR. (Accepted for Publication)
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Lore Noben (lore.noben@mmc.nl).
Intention to publish date
01/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31850850 (added 19/12/2019)