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Background: Patients undergoing minimally invasive vascular surgery under local anesthesia often experience significant anxiety and pain, which may compromise surgical outcomes. Virtual reality (VR)-based mindfulness interventions may offer a novel approach to enhance the perioperative experience. Methods: This single-center, prospective randomized controlled trial will enroll 160 patients, randomly assigned in a 1:1 ratio to either the intervention group (VR mindfulness intervention) or the control group (standard care). Primary outcome: State trait anxiety scale (STAI-State) measures anxiety. Secondary outcomes: Numeric Rating Scale (NRS) for pain, vital signs, sleep quality, fatigue levels, satisfaction. Expected Results: VR mindfulness intervention is anticipated to significantly reduce anxiety and pain levels while improving sleep quality, fatigue levels, and patient satisfaction. Conclusion: As a safe, cost-effective, and immersive non-pharmacological intervention, VR mindfulness therapy holds promise for enhancing perioperative care quality.
This study randomly assigned 160 patients whose groups had not yet been determined to two groups (intervention and control) in a 1:1 ratio. The block size was set to 4 based on the number of study groups. Randomization into 40 blocks was performed using SAS 9.4 software. Group allocation was concealed using the envelope method. A trained nurse sequentially opened envelopes according to patient enrollment order and assigned patients to the control or intervention group based on the allocation plan within each envelope.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness intervention based on virtual reality technology | Experimental | On the day of surgery, the first intervention took place in the preoperative waiting area. A mindfulness-trained operating room nurse guided the patient in wearing Huawei VR glasses and selecting pre-recorded mindfulness audio track A. The second intervention occurred in the operating room at the start of surgery. The patient again wore Huawei VR glasses and selected pre-recorded mindfulness audio track B. |
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| Routine Psychological Care | No Intervention | The control group patients received routine psychological care under identical medical conditions, including preoperative visits (providing information about the surgical procedure, expected outcomes, and other surgery-related details) and psychological support (comfort and encouragement). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness intervention based on virtual reality technology | Behavioral | On the day of surgery, the operating room staff brought patients to the preoperative waiting area in advance. Patients in the intervention group were assigned to a dedicated room within the preoperative waiting area. They were invited to sit in comfortable chairs and observe their surroundings. Operating room nurses trained in mindfulness assisted patients in putting on Huawei VR Glasses. They selected the pre-recorded Mindfulness Theory Course 1 + Guided Mindfulness Audio A for the first intervention. Subsequently, a second intervention was conducted when patients entered the operating room and surgery commenced. Operating room nurses assisted patients in wearing the Huawei VR Glass and selected the pre-recorded mindfulness theory course 2 + mindfulness guidance audio B. |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory(STAI-State) | Total scores ranging from 20 to 80, where higher scores indicate greater anxiety. | Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | The Numerical Rating Scale for Pain (NRS).The score from 0 to 10, where 0 means "no pain at all" and 10 means "the most severe pain" | Upon arrival at waiting room (baseline), 5 minutes after surgical incision (intraoperative), and immediately upon surgical closure (prior to operating room departure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Zhu, Graduate Student | Contact | 13545070566 | 824932159@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 11408299 | Background | Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and Alzheimer's disease in later life: longitudinal, population based study. BMJ. 2001 Jun 16;322(7300):1447-51. doi: 10.1136/bmj.322.7300.1447. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2026 | Jun 15, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| blood pressure |
Includes systolic blood pressure (mmHg),diastolic blood pressure (mmHg).The higher the number, the higher the blood pressure. |
| Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative),monitor every 5 minutes starting from the beginning of surgery until the end of surgery. |
| fatigued state | Brief Fatigue Inventory(BFI), with higher scores indicating greater fatigue. | Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1). |
| Sleep state | Leeds Sleep Evaluation Questionnaire (LSEQ).The total score ranging from 0 to 100 points,the higher the score, the worse the sleep quality | Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1). |
| Satisfaction scale | Each dimension is scored using a 5-point Likert scale ranging from " never" (1 point) to "very frequently or always" (5 points).Higher scores indicate greater patient satisfaction | 24 hours postoperatively (Day 1) |
| heart rate | Beat of the heart per minute.The bigger the number, the faster the heart rate. | Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative),monitor every 5 minutes starting from the beginning of surgery until the end of surgery. |
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