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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-03077-01 | Other Identifier | Swedish Ethical Review Authority |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Plus Usual Care | Experimental | 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. |
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| Usual Care | Active Comparator | Participants receive usual perioperative care without virtual reality during the corresponding preoperative period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pether Jildenstål, Professor | Contact | +46 76-026 66 58 | pether.jildenstal@med.lu.se |
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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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
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Open-label study because participants and clinical staff are aware of whether the preoperative virtual reality intervention is administered.
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| 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. |
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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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |