The effect of virtual reality information videos on anxiety in patients visiting the outpatient clinic of women with abnormal uterine bleeding
| ISRCTN | ISRCTN18233914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18233914 |
| Secondary identifying numbers | N17.053 |
- Submission date
- 02/04/2021
- Registration date
- 09/04/2021
- Last edited
- 04/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Abnormal uterine bleeding (AUB) is bleeding from the uterus that is longer than usual or that occurs at an irregular time. Bleeding may be heavier or lighter than usual and occur often or randomly.
The aim of this study is to investigate whether adding a virtual reality video to the standard information leaflet about the one-stop clinic 'Abnormal uterine bleeding' reduces anxiety.
Who can participate?
Women older than 18 and suffering from abnormal uterine bleeding, referred for a first consultation at the one-stop clinic 'Abnormal Uterine Bleeding' in Máxima MC.
What does the study involve?
Participants are randomly allocated to either the virtual reality group or the control group. The latter only receives the standard information leaflet about the clinic. Women in the VR group receive the standard information leaflet and a virtual reality video about the one-stop clinic.
What are the possible benefits and risks of participating?
Women in the virtual reality group receive additional information about the clinic, which possibly reduces anxiety. There is a small risk of motion sickness during or after watching the VR video.
Where is the study run from?
Máxima Medical Centre Veldhoven (the Netherlands)
When is the study starting and how long is it expected to run for?
November 2016 to September 2017
Who is funding the study?
Máxima Medical Centre Veldhoven (the Netherlands)
Who is the main contact?
Imke Reinders, imke.reinders@maastrichtuniversity.nl
Contact information
Scientific
PO Box 7777
Veldhoven
5500 MB
Netherlands
| Phone | +31 (0)408888380 |
|---|---|
| imke.reinders@maastrichtuniversity.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 |
| Participant information sheet | ISRCTN18233914_PIS_in_Dutch.pdf |
| Scientific title | The effect of VIrtual Reality information videos on anxiety in patients viSIting the ONe-stop-clinic for women with abnormal uterine bleeding |
| Study acronym | VISION |
| Study hypothesis | Anxiety or distress will be reduced in patients visiting our outpatient clinic for abnormal uterine bleeding by providing patient information through 360˚ virtual reality videos. |
| Ethics approval(s) | On 03/04/2017 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, The Netherlands; +31 (0)40 888 95 28; metc@mmc.nl) |
| Condition | Anxiety prior to visiting a one-stop clinic for women with abnormal uterine bleeding |
| Intervention | Prior to their first visit at the one-stop-clinic for Abnormal Uterine Bleeding, women were informed about this study by telephone. They were not explicitly informed about the role of virtual reality, but that the effect of a new method of patient education was investigated. The women were randomized by computer-generated block randomization. Women in the control group received standard care, which consisted of an information leaflet about the one-stop clinic with a reference to online information on the hospital website. Women in the intervention group received the standard information and were given access to a virtual reality information video about the clinic. |
| Intervention type | Other |
| Primary outcome measure | Anxiety measured using the visual analogue scale (VAS-anxiety) at baseline (measured before randomization) and in the waiting room before visiting the one-stop clinic |
| Secondary outcome measures | 1. Anxiety measured using the visual analoge scale (VAS-anxiety) during the visit (measured directly after the visit) 2. Anxiety measured using the State-Trait Anxiety Inventory (STAI-a) at baseline and in the watiting room 3. Feelings before the visit (feeling prepared, feeling worried, the feeling that better counseling would be helpful) measured on a questionnaire using a 5-point Likert scale in the waiting room. 4. Opinion about the received information about the clinic (completeness, quality, comprehensibility, remembering the information, satisfaction about the information, usefulness of the virtual reality video) measured on a 5-point Likert scale directly after the visit 5. Impression about counselling and anxiety of the women reported by the gynecologist on a 5-point Likert scale, reported at the end of the visit |
| Overall study start date | 23/11/2016 |
| Overall study end date | 21/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 80 women |
| Total final enrolment | 88 |
| Participant inclusion criteria | 1. Every woman suffering from abnormal uterine bleeding, referred for a first consultation at the one-stop clinic 'Abnormal Uterine Bleeding' 2. Women over the age of 18 |
| Participant exclusion criteria | 1. Poor understanding of the Dutch language 2. Referral to the clinic because of postmenopausal bleeding 3. Referral to the clinic with another reason than abnormal uterine bleeding |
| Recruitment start date | 10/04/2017 |
| Recruitment end date | 11/09/2017 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
De Run 4600
Veldhoven
5500 MB
Netherlands
Sponsor information
Hospital/treatment centre
PO Box 7777
Veldhoven
5500 MB Veldhoven
Netherlands
| Phone | +31 (0)408888380 |
|---|---|
| M.Bongers@mmc.nl | |
| Website | https://www.mmc.nl |
"ROR" |
https://ror.org/02x6rcb77 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a leading peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The data will be available until 10 years after completion of this trial. All data are anonymized. The reason for viewing data must be mentioned and the researchers will judge if they give insight in (a part of) the dataset |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/05/2021 | No | Yes | ||
| Protocol file | 04/05/2021 | No | No |
Additional files
- ISRCTN18233914_Protocol_no date.pdf
- uploaded 04/05/2021
- ISRCTN18233914_PIS_in_Dutch.pdf
- uploaded 04/05/2021
Editorial Notes
04/05/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version n/a, no date.
2. The participant information sheet was uploaded as an additional file.
09/04/2021: Trial's existence confirmed by METC Máxima MC
