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 |
| Secondary identifying numbers | N17.017 |
- 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
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
Scientific
PO Box 7777
Veldhoven
5500 MB
Netherlands
 ORCID ID |
0000-0002-4894-0873 |
|---|---|
| Phone | +31 (0)40 888 8384 |
| Lore.noben@mmc.nl |
Study information
| Study design | Single-centre randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 | 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 study start date | 01/11/2016 |
| Completion date | 31/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
Veldhoven
5500MB
Netherlands
Sponsor information
Hospital/treatment centre
PO Box 7777
Veldhoven
5500 MB
Netherlands
| Phone | +31 (0)40 888 8384 |
|---|---|
| Lore.noben@mmc.nl | |
| Website | https://www.mmc.nl/ |
"ROR" |
https://ror.org/02x6rcb77 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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.
