Recovery With Virtual Reality for Stress and Pain (ReVRS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Preoperative Anxiety; Postoperative Recovery
• Intervention / Treatment: Behavioral: Preoperative Virtual Reality; Other: Usual Perioperative Care

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:

1. Virtual reality plus usual perioperative care.
2. 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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pether Jildenstål, Professor; Phone Number: +46 76-026 66 58; Email: pether.jildenstal@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Plus Usual Care; 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.	Behavioral: Preoperative Virtual Reality; 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.
Active Comparator: Usual Care; Participants receive usual perioperative care without virtual reality during the corresponding preoperative period.	Other: Usual Perioperative Care; Participants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 72 hours after surgery
Postoperative Opioid Consumption	Total postoperative opioid consumption will be calculated and converted to intravenous morphine milligram equivalents.	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.	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.	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.	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.	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.	10 days after surgery

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative Care; Postoperative Pain; Virtual Reality; Postoperative Nausea and Vomiting; Quality of Recovery; Opioid Consumption; Preoperative Anxiety; QoR-15; Gynecologic Surgery; Nonpharmacologic Intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 2026-03077-01 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No