Virtual reality used to reduce anxiety before a gynaecologic surgery or during chemotherapy - is it working?
| ISRCTN | ISRCTN31062729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31062729 |
| Secondary identifying numbers | 01 |
- Submission date
- 23/10/2025
- Registration date
- 28/10/2025
- Last edited
- 28/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Preoperative anxiety poses a significant challenge in gynaecologic surgery, affecting patient outcomes and healthcare costs. Virtual reality (VR) relaxation therapy show s promise as an alternative intervention, supported by literature findings and a survey revealing high patient interest. This study aims to investigate the effectiveness of VR relaxation therapy in reducing preoperative anxiety levels, potentially informing innovative approaches to anxiety management in surgical settings. In the second part, the effect of VR relaxation on patient wellbeing during application of chemotherapy or Immunotherapy for a gynaecological malignancy will be analysed. Previous studies found a reduction of side effects from chemotherapy in patients with lower levels of stress and anxiety.
Who can participate?
Female patients above the age of 18 years scheduled for elective gynaecological surgery (part I) or IV cancer treatment (arm II)
What does the study involve?
The study involves a VR therapy of 15 minutes with relaxing film and music as well as the filling out questionnaires.
What are the possible benefits and risks of participating?
Benefits:
1. Reduction in anxiety and stress
2. Enhanced patient comfort and satisfaction
3. Non-invasive intervention with a minimal risk of adverse effects
Risks:
1. Potential discomfort during VR sessions
2. Limited generalizability of study findings
3. Time and resource constraints for implementation of VR therapy sessions
Where is the study run from?
Inselspital Bern, Frauenklinik (Switzerland)
When is the study starting and how long is it expected to run for?
August 2025 to September 2026
Who is funding the study?
1. Angela Reiffer Stiftung (Switzerland)
2. Johanna-Dürmüller-Bol Stiftung (Switzerland)
3. Parrotia Stiftung (Switzerland)
Who is the main contact?
Dr Flurina Saner, flurina.saner@insel.ch
Contact information
Public, Scientific, Principal investigator
Friedbühlstrasse 12
Bern
3012
Switzerland
 ORCID ID |
0000-0003-2469-9824 |
|---|---|
| Phone | +41 (0)632 10 10 |
| flurina.saner@insel.ch |
Study information
| Study design | Single-center non-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Virtual reality – an emerging source for relief of anxiety in patients undergoing gynaecologic surgery or during chemotherapy? A randomised controlled clinical trial |
| Study acronym | VRelax |
| Study objectives | Aim 1: The primary objective of the study is to evaluate the efficacy of Virtual Reality Relaxation Therapy in reducing preoperative anxiety levels among adult female patients undergoing elective gynaecological surgery. Aim 2: In women requiring chemotherapy for a gynaecological cancer, we aim to analyse if the use of Virtual Reality Relaxation Therapy during application of intravenous chemotherapy improves patient wellbeing. |
| Ethics approval(s) |
Approved 27/08/2025, Kantonale Ethikkommission (KEK) (Murtenstrasse 31, Bern, 3010, Switzerland; +41 (0)31 633 70 70; katharina.kunzelmann@be.ch), ref: 2025-00877 |
| Health condition(s) or problem(s) studied | Anxiety before surgery and during chemotherapy |
| Intervention | Method of Randomization: via REDcap Part I: 1. Ambulatory vs stationary (x2) 2. Suspected or diagnosed cancer vs benign (x2) 3. Aged 18-59 years vs 60+ years (x2) Part II: 1. Chemo (single agent and combined treatment) vs immuno-/targeted-/antibody therapy (x2) 2. Breast vs gynaecological cancer (x2) 3. Aged 18-59 years vs 60+ years (x2) There are two arms with the same layout, but in ‘different’ situations: 1: VR Therapy prior to gynaecological operation 2: VR Therapy during application of chemotherapy/immunotherapy During the study intervention, participants will be equipped with VR goggles to provide a relaxing VR session. The investigator will adjust the goggles while the patient lies in bed or sits on a chair and will play a 15-minute video featuring nature scenes and relaxing music. The VRelax videos have been produced for this study specifically; all participants can choose one out of three 4K high-resolution videos available based on their interest. The three videos available contain relaxing nature scenes (landscapes and animals) on either snow/winter, underwater scenes or savannah. Patients can remove the goggles and stop the intervention at any time, and the investigator will demonstrate how to do so. The investigator will monitor the patient for any signs of distress during the session and assist in removing the goggles afterward. In case of early termination of the VR procedure, the timepoint will be recorded. This approach ensures a controlled, supportive environment to maximize the effectiveness of VR relaxation therapy in reducing anxiety and stress. |
| Intervention type | Device |
| Pharmaceutical study type(s) | device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | VR goggles (MetaQuest 3) |
| Primary outcome measure | Anxiety measured by the Hamilton Anxiety Score Hospital Anxiety and Depression Scale (HADS) before and after the VR intervention |
| Secondary outcome measures | 1.Anxiety measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) before and after the VR intervention 2. Anxiety measured by Visual Analogue Scales for Anxiety (VAS-A) before and after the VR intervention 3. Stress in arm I measured by cortisol sputum levels before and after the VR intervention 4. Side effects of chemotherapy measured by anamnesis 3 days after the VR intervention |
| Overall study start date | 27/08/2025 |
| Completion date | 01/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Part I: 86, Part 2 86, Total 172 |
| Key inclusion criteria | 1. Female gender 2. Aged 18 years or older 3. Scheduled for elective gynaecological surgery (arm I) or IV cancer treatment (arm II) 4. Absence of severe visual or mental impairments 5. Willing and able to consent 6. No epilepsy or depression or anxiety disorder |
| Key exclusion criteria | 1. Aged below 18 years 2. Severe motion sickness 3. Pre-existing epilepsy, depression or anxiety disorder 4. Significant respiratory disease requiring continuous oxygen administration 5. Medical conditions requiring intensive medical care 6. Inability to wear the VR device 7. Pregnancy |
| Date of first enrolment | 11/11/2025 |
| Date of final enrolment | 01/09/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bern
3010
Switzerland
Sponsor information
Hospital/treatment centre
Friedbühlstrasse 12
Bern
3012
Switzerland
| Phone | +41 (0)632 10 10 |
|---|---|
| frauenklinik@insel.ch | |
| Website | https//:insel.ch |
Funders
Funder type
Charity
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Parrotia Foundation
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date (01/01/2027) |
Editorial Notes
24/10/2025: Study's existence confirmed by the Kantonale Ethikkommission (KEK).
