Anxiety, Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness intervention based on virtual reality technology
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.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years old. 2. ASA physical status classification I-III. 3. Diagnosis of superficial varicose veins confirmed by clinical examination and imaging studies (e.g., Doppler ultrasound, digital subtraction angiography), with documented venous insufficiency and great saphenous vein varicosity; CEAP classification grade 3-5. 4. Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia. 5. Voluntary participation in this study with signed informed consent. 6. Able to cooperate with all examinations and follow-up visits required during the study. 7. No other severe systemic diseases or surgical contraindications (e.g., severe cardiopulmonary dysfunction, coagulation abnormalities) that may compromise surgical safety or interpretation of study results.
Exclusion criteria
1. Cognitive impairment (Mini-Mental State Examination \[MMSE\] score ≤26). 2. Inability to wear VR equipment, or presence of sensory impairment (blindness or deafness). 3. History of the same type of surgery. 4. Presence of chronic or acute pain unrelated to peripheral vascular disease diagnosis. 5. Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the past 30 days. 6. Pregnancy or breastfeeding. 7. Currently receiving or previously participated in psychological intervention. 8. Prior mindfulness experience, documented history of psychiatric illness in medical records, or consultation with a trauma psychologist during the current hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory（STAI-State） | Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure) | Total scores ranging from 20 to 80, where higher scores indicate greater anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Upon arrival at waiting room (baseline), 5 minutes after surgical incision (intraoperative), and immediately upon surgical closure (prior to operating room departure) | 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" |
| 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. | Includes systolic blood pressure (mmHg),diastolic blood pressure (mmHg).The higher the number, the higher the blood pressure. |
| fatigued state | Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1). | Brief Fatigue Inventory（BFI）, with higher scores indicating greater fatigue. |
| Sleep state | Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1). | Leeds Sleep Evaluation Questionnaire (LSEQ).The total score ranging from 0 to 100 points,the higher the score, the worse the sleep quality |
| Satisfaction scale | 24 hours postoperatively (Day 1) | 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 |
| 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. | Beat of the heart per minute.The bigger the number, the faster the heart rate. |
Countries
China
Contacts
CONTACTMin Zhu, Graduate Student
Outcome results
None listed