Condition category
Pregnancy and Childbirth
Date applied
05/11/2019
Date assigned
05/11/2019
Last edited
05/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

https://www.mmc.nl/

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

Publication citations

Additional files

Editorial Notes

05/11/2019: Trial's existence confirmed by ethics committee.