Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain (VR-TSP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 4
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
A randomized controlled, prospective, multicenter, open label, superiority trial aims to evaluate the effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain.
详细描述
215 eligible patients will be enrolled. All enrolled patients will have an NRS score at 24 hours postoperatively, and those with a score greater than or equal to 4 will be randomly assigned to the test and control groups.
Patients in the experimental group will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes.
The control group will not experience postoperative analgesic adjuvant therapy software and will only record the pain level within 30 minutes. Subjects will complete a study summary form upon completion of follow-up.
All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection (5 ml): 50 mg/piece, intravenous injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age greater than or equal to 18 years.
- •2.Patients within 1 day after thoracoscopic surgery.
- •3.Junior high school degree or above, Mandarin communication is unimpeded, with certain Internet knowledge and mobile phone reading and writing skills.
- •4.The score of the numeric grading scale (NRS) at 24 hours postoperatively ≥ 4 points.
- •5.Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to complete the follow-up as required by the protocol.
排除标准
- •1.Patients with severe cognitive impairment.
- •2.Patients with a previous diagnosis of epilepsy, dementia, migraine, or other neurological disease that may result in the inability to use postoperative analgesic adjuvant therapy software or that may have adverse effects.
- •3.Patients who are unable to understand or speak Mandarin.
- •4.Patients who have visual abnormalities, severe hearing impairment, or motion sickness, etc., and are unable to view VR.
- •5.Patients with trauma to the eyes, face, or neck that prevents the comfortable use of the VR device.
- •6.Patients with severe heart, liver, kidney, hematologic, digestive, nervous system diseases and malnutrition.
- •7.Patients who have previously used virtual reality software for pain that has not responded to treatment.
- •8.Patients with a history of severe alcohol abuse, long-term heavy drinking, and symptoms of alcohol dependence.
- •9.Patients who have participated in any analgesic interventional study within the past 1 week.
- •10.Females who are pregnant or plan to become pregnant during the study.
- •11.The patient or their immediate family member works for a digital health or pharmaceutical company for acute or chronic pain treatment.
- •12.Patients who are unable to use electronic devices such as smartphones.
- •13.Other conditions that the investigator considers inappropriate for participation in a clinical trial.
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.
The NRS score is a commonly used postoperative pain assessment tool. The score uses a numeric scale from 0 to 10, on which patients are asked to mark their level of pain, with 0 being no pain and 10 being the most severe pain.
次要结局
- Incidence of serious adverse events(Assessment of serious adverse events is completed within 2 days postoperatively)
- Incidence of adverse events(Assessment of adverse events is completed within 2 days postoperatively)