Postoperative Pain, Postoperative Recovery, Preoperative Anxiety
Conditions
Keywords
Virtual Reality, Perioperative Care, Gynecologic Surgery, Quality of Recovery, QoR-15, Preoperative Anxiety, Postoperative Pain, Opioid Consumption, Postoperative Nausea and Vomiting, Nonpharmacologic Intervention
Brief 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. 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: 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.
Interventions
BEHAVIORALPreoperative 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.
Participants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study because participants and clinical staff are aware of whether the preoperative virtual reality intervention is administered.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Postoperative Recovery Measured With QoR-15 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Preoperative Anxiety | 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. |
| Postoperative Pain Intensity | 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. |
| Postoperative Opioid Consumption | During the first 24 hours after surgery | Total postoperative opioid consumption will be calculated and converted to intravenous morphine milligram equivalents. |
| Incidence of Postoperative Nausea and Vomiting | During the first 24 hours after surgery | Number and proportion of participants experiencing nausea, vomiting, or both during the postoperative period. |
| Duration of Stay in the Post-Anesthesia Care Unit | On the day of surgery | Time from admission to discharge from the post-anesthesia care unit. |
| Quality of Recovery at 72 Hours Measured With QoR-15 | 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. |
| Quality of Recovery on Postoperative Day 7 Measured With QoR-15 | 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. |
| Quality of Recovery on Postoperative Day 10 Measured With QoR-15 | 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. |
Contacts
CONTACTPether Jildenstål, Professor
Outcome results
None listed