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
Qualifiers
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
Treatments tested in this trial
- Preoperative Virtual Reality
- Usual Perioperative Care
Treatment groups
140 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov