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NCT Number: NCT07679022

Recovery With Virtual Reality for Stress and Pain

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative Virtual Reality

Behavioral

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 Care

Other

Participants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Preoperative Anxiety

    Time frame: From immediately before to immediately after the intervention, approximately 10-20 minutes

    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.

  2. Postoperative Pain Intensity

    Time frame: Up to 72 hours after surgery

    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.

  3. Postoperative Opioid Consumption

    Time frame: During the first 24 hours after surgery

    Total postoperative opioid consumption will be calculated and converted to intravenous morphine milligram equivalents.

  4. Incidence of Postoperative Nausea and Vomiting

    Time frame: During the first 24 hours after surgery

    Number and proportion of participants experiencing nausea, vomiting, or both during the postoperative period.

  5. Duration of Stay in the Post-Anesthesia Care Unit

    Time frame: On the day of surgery

    Time from admission to discharge from the post-anesthesia care unit.

  6. Quality of Recovery at 72 Hours Measured With QoR-15

    Time frame: 72 hours after surgery

    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. Quality of Recovery on Postoperative Day 7 Measured With QoR-15

    Time frame: 7 days after surgery

    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.

  8. Quality of Recovery on Postoperative Day 10 Measured With QoR-15

    Time frame: 10 days after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pether Jildenstål, Professor

CONTACT

[email protected]

+46 76-026 66 58

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Recovery With Virtual Reality for Stress & Pain (ReVRS)

Acronym: ReVRS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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