Application Effect of VR Combined With Lidocaine Local Infiltration Anesthesia in PICC Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Success rate of one puncture
研究概览
简要总结
We try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of PICC catheter school-age children. Using the convenience sampling method, the selection in May 2020, 2021 - may need to PICC placement of children as the research object, is divided into three groups A, B, c, group A in ultrasound guided by PICC placement; Group B and group C adopt VR intervention, and 5 min before the beginning of the next surgery using VR equipment. Group B was anesthetized after the needle was placed into the guide wire, and group C was anesthetized before the needle was placed into the guide wire.
详细描述
This study investigated the effect of VR combined with lidocaine local infiltration anesthesia in peripherally inserted central catheter (PICC) insertion, aiming to improve one-needle puncture success rate, reduce pain, reduce fear, improve compliance and catheterization time.
From May 2020 to May 2021, children requiring PICC were recruited by convenience sampling and divided into three groups: A, B and C. Group A was implanted with PICC under ultrasound guidance. Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began. Group B was anesthetized after the puncture needle was sent into the guide wire, and group C was anesthetized before the puncture needle was sent into the guide wire.The success rate of one puncture, pain, fear, compliance and catheterization time were compared among the three groups. A sample size and power analysis were conducted to determine the sample size required.The investigators assumed a medium effect size (f2 = 0.25) of the active VR. Using 2 tails and alpha = .05, a fixed-effect linear regression model would offer power greater than 0.80 with a total sample size of 159 children. To ensure adequate power, the investigators planned to recruit 56 participants for each group. Three groups were all operated by PICC specialist nurses, and the standard operation procedure of PICC catheterization was implemented in accordance with the infusion therapy nursing practice guidelines and implementation rules and the 2016 INS guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged between 6 and 12 years.
- •Undergoing their inaugural ultrasound-guided PICC insertion in an up.
- •Voluntarper limby participation and informed consent by parents or guardians.
排除标准
- •Children with severe cardiocerebral conditionsor critical coagulopathies.
- •Known lidocaine allergies.
- •Severe mental illness or cognitive impairment in patients.
研究组 & 干预措施
Group A
Catheters were implanted according to PICC routine procedures:Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter
Group B
The virtual reality device used was PICO NE2, with accessories including helmet equipment , (with a field of view of about 98°, built-in Android 8.1 system, Qualcomm Snapdragon processor), and an infrared sensor (handle)and the VR headset was worn in the optimal state 5 minutes before catheterization.After preparing the vr device,Sterilized skin -maximum sterile barrier-ultrasound-guided puncture insertion of guidewire -local infiltration anesthesia with 2% lidocaine -broad skin, insertion of skin expansion sheath -insertion of catheter
干预措施: Virtual reality technology (Device)
Group C
The virtual reality device used was PICO NE2, with accessories including helmet equipment , (with a field of view of about 98°, built-in Android 8.1 system, Qualcomm Snapdragon processor), and an infrared sensor (handle)and the VR headset was worn in the optimal state 5 minutes before catheterization.After preparing the vr devicea and disinfecting the skin, local infiltration anesthesia was administered at the prepuncture site under ultrasound guidance using 0.5ml of 2% lidocaine. Approximately 2 minutes later, a skin puncture was performed and a guidewire was inserted. A broad incision was made to accommodate the torn vascular sheath for delivering the catheter to the predetermined length
干预措施: Virtual reality technology (Device)
Group C
The virtual reality device used was PICO NE2, with accessories including helmet equipment , (with a field of view of about 98°, built-in Android 8.1 system, Qualcomm Snapdragon processor), and an infrared sensor (handle)and the VR headset was worn in the optimal state 5 minutes before catheterization.After preparing the vr devicea and disinfecting the skin, local infiltration anesthesia was administered at the prepuncture site under ultrasound guidance using 0.5ml of 2% lidocaine. Approximately 2 minutes later, a skin puncture was performed and a guidewire was inserted. A broad incision was made to accommodate the torn vascular sheath for delivering the catheter to the predetermined length
干预措施: different timing of lidocaine injection (Other)
结局指标
主要结局
Success rate of one puncture
时间窗: Immediately after the end of the catheterization
The blood vessel was entered by one puncture, and there was no other operation to explore the subcutaneous vessel, pull out the needle or change the puncture site
次要结局
- pain score(Immediately after the end of the catheterization)
研究者
Qi Yu
Deputy chief nurse
Tongji Hospital