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临床试验/NCT06061198
NCT06061198已完成不适用

Impact of Virtual Reality on Patient's Anxiety During Upper Limb Surgery Under Regional Anesthesia

University Hospital, Mahdia2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
hypnovel consumption during surgery

研究概览

简要总结

this study was conducted in TAHER SFAR Hospital . it included 68 patients and it aims to evaluate the impact of virtual reality on patients undergoing upper limb surgery under regional anesthesia and evaluate the consumption of hypnotics during surgery , anxiety levels and patients satisfaction. this study contain 2 arms , each arm contain 34 patients . first arm received regional anesthesia and surgery under virtual reality using a VR gear . second arm received standard care

详细描述

patients who had surgery with the virtual reality experience or the VR- group ( group of patients who had surgery with standard measures without virtual reality) The patient was setup comfortably on the operating table.The echo-guided regional anesthesia appropriate to the surgical procedure is performed by an experienced anesthesiologist.In the RV+ patients, loco regional anesthesia was performed before installing the VR mask and before initiating immersing in the virtual reality space. anesthesia protocol was performed before initiating VR experience to maintain audiovisual and cognitive contact with the patient and detect possible complications For the virtual reality immersion for the VR+ group, we used an OCULUS SAMSUNG GEAR VR, a virtual reality headset connected to a SAMSUNG S7 Edge phone with headphones.The headset was worn after the loco regional anesthesia and removed at the end of the procedure.The helmet is adapted to each patient according to his head circumference measurements and the image adjustment is personalized.The VR session consists of an immersion in a natural relaxation environment produced by an application downloaded from the OCULUS STORE: VR Guided Meditation.The application offers a choice of 4 environments: Relaxing day on a tropical beach, beautiful sunset beach, mountain sunrise, or forest nap experiences . The choice of the environment is randomized according to the patient's preferences.For patients who belongs to the VR- group, the procedure was performed under standard conditions with a drape separating the patient from the operating site During surgery, the vital signs: HR, PANI, SpO2 were collected at the different peri-operative moments respectively at the entrance to the operating room (T0), 15 minutes after ALR (T1), 30 minutes after ALR (T2), 30 minutes (T3), 1 hour (T4) and 2 hours (T5) An intraoperative assessment of anxiety was performed after 15 minutes of ALR, i.e. at T1 by the LIKERT scale The anesthesist could administer anxiolytics outside of the contraindications. The molecule of choice is Midazolam and the dose taken is noted on the data collection form The administration of anxiolytics (Midazolam) is judged by clinical criteria determined in the protocol:- Anxiety during the operation judged as painful or important (higher than2 on the LIKERT scale) The session can be interrupted during the procedure for medical reasons or at the patient's request.If the local anesthesia fails and the patient is converted to general anesthesia, the protocol is cancelled and a standard induction is performed by the anesthesiologist.The events of desaturation (SpO2 < 90%), apnea, administration of anxiolytics administration of anxiolytics (to reach a minimal level of anxiety) were indicated on the data collection form.For both RV+ and RV- groups, postoperative anxiety was assessed using the scores:1- Postoperative STAI at H1 postoperative2- patient satisfaction evaluated by a LIKERT scale

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient classified ASA 1 , 2 or 3
  • patients undergoing an upper-limb surgery under regional anesthesia

排除标准

  • regional anesthesia failure
  • local anesthetics intoxications
  • symptoms of cyber-sickness

结局指标

主要结局

hypnovel consumption during surgery

时间窗: From enrollment to the end of treatment at 10 weeks

the required dose of Midazolam for a LIKERT intraoperative anxiety score goal \< 2

次要结局

  • satisfaction level during surgery(at the end of the procedure)
  • pre-operative patients's anxiety level by LIKERT score(From enrollment to the end of treatment at 10 weeks)
  • pre-operative patients's anxiety level by STAI-6 score(From enrollment to the end of treatment at 10 weeks)
  • per-operative patients's anxiety level by LIKERT score(From enrollment to the end of treatment at 10 weeks)
  • vitals : heart rate(From enrollment to the end of treatment at 10 weeks)
  • post-operative patients's anxiety level by LIKERT score(From enrollment to the end of treatment at 10 weeks)
  • vitals : oxygen saturation(From enrollment to the end of treatment at 10 weeks)
  • post-operative patients's anxiety level by STAI-6 score(From enrollment to the end of treatment at 10 weeks)
  • vitals : systolic pressure(From enrollment to the end of treatment at 10 weeks)

研究者

发起方
University Hospital, Mahdia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Majdoub Ali MD

medical professor

University Hospital, Mahdia

研究点 (2)

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