Recovery With Virtual Reality for Stress and Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Preoperative Virtual Reality
BehavioralA 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 interventionParticipants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality Plus Usual CareExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
24 hours after surgerySecondary outcomes
1
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.
Time frame
From immediately before to immediately after the intervention, approximately 10-20 minutes2
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.
Time frame
Up to 72 hours after surgery3
Postoperative Opioid Consumption
Total postoperative opioid consumption will be calculated and converted to intravenous morphine milligram equivalents.
Time frame
During the first 24 hours after surgery4
Incidence of Postoperative Nausea and Vomiting
Number and proportion of participants experiencing nausea, vomiting, or both during the postoperative period.
Time frame
During the first 24 hours after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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