Preoperative AnxietyReVRSNCT07679022
Recovery With Virtual Reality for Stress and Pain
A study testing Preoperative Virtual Reality and Usual Perioperative Care in people with Preoperative Anxiety and Postoperative Pain, run by Region Skane.
Trial summary
This randomized controlled trial will evaluate whether a brief preoperative virtual reality intervention reduces anxiety and improves early recovery in adults undergoing elective gynecological surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety, Postoperative Pain, Postoperative Recovery
- What is being tested?
- Preoperative Virtual Reality and Usual Perioperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Scheduled to undergo elective gynecological surgery according to the study protocol at a participating center where virtual reality can be provided.
- Able and willing to provide informed consent for study participation, 1:1 randomization, and use of virtual reality.
Who cannot join
- Increased risk of adverse effects related to virtual reality, including pronounced motion sickness, claustrophobia, or photosensitive epilepsy.
- Active substance use disorder or active misuse of alcohol or illicit drugs.
- Severe chronic pain and/or regular preoperative opioid treatment, as defined in the study protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Recovery With Virtual Reality for Stress & Pain (ReVRS)
This randomized controlled trial will evaluate whether a brief preoperative virtual reality intervention reduces anxiety and improves early recovery in adults undergoing elective gynecological surgery. Approximately 140 participants will be randomly assigned in a 1:1 ratio to either virtual reality in addition to usual care or usual care alone. The virtual reality intervention will consist of approximately 10-20 minutes of an immersive relaxation experience before surgery. The primary outcome is the change in preoperative anxiety measured before and after the intervention. Secondary outcomes include postoperative quality of recovery, pain, opioid consumption, postoperative nausea and vomiting, and early recovery-related healthcare outcomes.
Read the detailed description
Preoperative anxiety and postoperative pain may negatively affect patients' recovery after surgery. Virtual reality may provide a non-pharmacological method of distraction and relaxation, but its effect on perioperative anxiety and early postoperative recovery requires further evaluation.
This prospective, randomized, parallel-group controlled trial will include approximately 140 adults undergoing elective gynecological surgery. After providing informed consent, participants will be randomized in a 1:1 ratio to one of two groups:
- Virtual reality plus usual perioperative care.
- Usual perioperative care alone.
Participants assigned to the intervention group will use a virtual reality headset for approximately 10-20 minutes before surgery and view an immersive relaxation environment. The intervention may be discontinued at any time if the participant experiences discomfort, nausea, dizziness, anxiety, or other adverse symptoms.
The primary outcome is the change in preoperative anxiety from immediately before to immediately after the intervention period, assessed using the State-Trait Anxiety Inventory-State scale and/or a numerical rating scale for anxiety.
Secondary outcomes include quality of recovery measured with the Quality of Recovery-15 questionnaire, postoperative pain measured using a numerical rating scale, opioid consumption expressed as morphine milligram equivalents, postoperative nausea and vomiting, time spent in the postoperative care unit, and other indicators of early postoperative recovery. Follow-up assessments are planned at approximately 24 and 72 hours and on postoperative days 7 and 10.
The study will examine whether preoperative virtual reality reduces anxiety and whether any reduction is associated with improved postoperative recovery and reduced symptom burden.
- Being tested
- Preoperative Virtual Reality, Usual Perioperative Care
- Keywords
- Virtual Reality, Perioperative Care, Gynecologic Surgery, Quality of Recovery, QoR-15, Preoperative Anxiety, Postoperative Pain, Opioid Consumption, Postoperative Nausea and Vomiting, Nonpharmacologic Intervention
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Virtual RealityBehavioural
A single preoperative virtual reality session lasting approximately 10-20 minutes, administered in the waiting or preoperative area. Participants view calm nature, relaxation, or guided-breathing scenes using a virtual reality headset. The intervention is intended to provide relaxation, comfort, and distraction before surgery.
Usual Perioperative CareOther
Participants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Plus Usual Care | Experimental | Participants receive a preoperative virtual reality session in addition to usual perioperative care. The session lasts approximately 10-20 minutes and is delivered in the waiting or preoperative area using calm nature or relaxation scenes intended to promote comfort and distraction. Receives: Behavioral: Preoperative Virtual Reality |
| Usual Care | Active comparator | Participants receive usual perioperative care without virtual reality during the corresponding preoperative period. Receives: Other: Usual Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Postoperative Recovery Measured With QoR-15
Postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: 24 hours after surgery
Secondary outcomes (8)
Change in Preoperative Anxiety
Anxiety will be assessed before and after the preoperative intervention period using the anxiety measure specified in the study protocol. Higher scores indicate greater anxiety.
Measured: From immediately before to immediately after the intervention, approximately 10-20 minutes
Postoperative Pain Intensity
Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Up to 72 hours after surgery
Postoperative Opioid Consumption
Total postoperative opioid consumption will be calculated and converted to intravenous morphine milligram equivalents.
Measured: During the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Number and proportion of participants experiencing nausea, vomiting, or both during the postoperative period.
Measured: During the first 24 hours after surgery
Duration of Stay in the Post-Anesthesia Care Unit
Time from admission to discharge from the post-anesthesia care unit.
Measured: On the day of surgery
Quality of Recovery at 72 Hours Measured With QoR-15
Quality of postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: 72 hours after surgery
Quality of Recovery on Postoperative Day 7 Measured With QoR-15
Quality of postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: 7 days after surgery
Quality of Recovery on Postoperative Day 10 Measured With QoR-15
Quality of postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial with participants allocated in a 1:1 ratio to preoperative virtual reality plus usual care or usual care alone.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679022
- Sponsor's protocol ID
- 2026-03077-01
- Other IDs
- 2026-03077-01
- Acronym
- ReVRS
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains sensitive health information. Due to privacy and confidentiality concerns, and in accordance with ethical approval and applicable data protection regulations (GDPR), individual-level data cannot be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery With Virtual Reality for Stress & Pain (ReVRS)
- ClinicalTrials.gov ID
- NCT07679022
- Acronym / sponsor ID
- ReVRS / 2026-03077-01
- Keywords
- Virtual Reality, Perioperative Care, Gynecologic Surgery, Quality of Recovery, QoR-15, Preoperative Anxiety, Postoperative Pain, Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will evaluate whether a brief preoperative virtual reality intervention reduces anxiety and improves early recovery in adults undergoing elective gynecological surgery. Approximately 140 participants will be randomly assigned in a 1:1 ratio to either virtual reality in addition to usual care or usual care alone. The virtual reality intervention will consist of approximately 10-20 minutes of an immersive relaxation experience before surgery. The primary outcome is the change in preoperative anxiety measured before and after the intervention. Secondary outcomes include postoperative quality of recovery, pain, opioid consumption, postoperative nausea and vomiting, and early recovery-related healthcare outcomes.
Detailed description
Preoperative anxiety and postoperative pain may negatively affect patients' recovery after surgery. Virtual reality may provide a non-pharmacological method of distraction and relaxation, but its effect on perioperative anxiety and early postoperative recovery requires further evaluation.
This prospective, randomized, parallel-group controlled trial will include approximately 140 adults undergoing elective gynecological surgery. After providing informed consent, participants will be randomized in a 1:1 ratio to one of two groups:
- Virtual reality plus usual perioperative care.
- Usual perioperative care alone.
Participants assigned to the intervention group will use a virtual reality headset for approximately 10-20 minutes before surgery and view an immersive relaxation environment. The intervention may be discontinued at any time if the participant experiences discomfort, nausea, dizziness, anxiety, or other adverse symptoms.
The primary outcome is the change in preoperative anxiety from immediately before to immediately after the intervention period, assessed using the State-Trait Anxiety Inventory-State scale and/or a numerical rating scale for anxiety.
Secondary outcomes include quality of recovery measured with the Quality of Recovery-15 questionnaire, postoperative pain measured using a numerical rating scale, opioid consumption expressed as morphine milligram equivalents, postoperative nausea and vomiting, time spent in the postoperative care unit, and other indicators of early postoperative recovery. Follow-up assessments are planned at approximately 24 and 72 hours and on postoperative days 7 and 10.
The study will examine whether preoperative virtual reality reduces anxiety and whether any reduction is associated with improved postoperative recovery and reduced symptom burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial with participants allocated in a 1:1 ratio to preoperative virtual reality plus usual care or usual care alone.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Plus Usual Care | Experimental | Behavioral: Preoperative Virtual RealityParticipants receive a preoperative virtual reality session in addition to usual perioperative care. The session lasts approximately 10-20 minutes and is delivered in the waiting or preoperative area using calm nature or relaxation scenes intended to promote comfort and distraction. |
| Usual Care | Active comparator | Other: Usual Perioperative CareParticipants receive usual perioperative care without virtual reality during the corresponding preoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Scheduled to undergo elective gynecological surgery according to the study protocol at a participating center where virtual reality can be provided.
- Able and willing to provide informed consent for study participation, 1:1 randomization, and use of virtual reality.
Key exclusion criteria (3 listed)
- Increased risk of adverse effects related to virtual reality, including pronounced motion sickness, claustrophobia, or photosensitive epilepsy.
- Active substance use disorder or active misuse of alcohol or illicit drugs.
- Severe chronic pain and/or regular preoperative opioid treatment, as defined in the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Virtual RealityA single preoperative virtual reality session lasting approximately 10-20 minutes, administered in the waiting or preoperative area. Participants view calm nature, relaxation, or guided-breathing scenes using a virtual reality headset. The intervention is intended to provide relaxation, comfort, and distraction before surgery. | Behavioural | Virtual Reality Plus Usual Care |
| Usual Perioperative CareParticipants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period. | Other | Usual Care |
Primary outcome
Quality of Postoperative Recovery Measured With QoR-15
Time frame: 24 hours after surgery
Postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
8 secondary outcomes
Change in Preoperative Anxiety
Time frame: From immediately before to immediately after the intervention, approximately 10-20 minutes
Postoperative Pain Intensity
Time frame: Up to 72 hours after surgery
Postoperative Opioid Consumption
Time frame: During the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Time frame: During the first 24 hours after surgery
Duration of Stay in the Post-Anesthesia Care Unit
Time frame: On the day of surgery
Quality of Recovery at 72 Hours Measured With QoR-15
Time frame: 72 hours after surgery
Quality of Recovery on Postoperative Day 7 Measured With QoR-15
Time frame: 7 days after surgery
Quality of Recovery on Postoperative Day 10 Measured With QoR-15
Time frame: 10 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive health information. Due to privacy and confidentiality concerns, and in accordance with ethical approval and applicable data protection regulations (GDPR), individual-level data cannot be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Virtual Reality and Usual Perioperative Care in people with Preoperative Anxiety and Postoperative Pain, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pether Jildenstål, Professor (+46 76-026 66 58, pether.jildenstal@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Postoperative Recovery Measured With QoR-15 (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.