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临床试验/NCT06649383
NCT06649383招募中4 期

Virtual Reality for Elderly Patients in Anesthesia and Surgical Care

Pether Jildenstal4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月16日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
90
试验地点
4
主要终点
propofol mg/kg

研究概览

简要总结

We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.

详细描述

This study is a randomized controlled trial based on both quantitative and qualitative methods. Inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery/treatment under local anesthesia and sedation. Randomization is to either standard sedation or sedation/VR. Randomization is carried out using mixed, sealed envelopes. The studies will be conducted at the following locations:

Hallands Hospital, Kungsbacka: Open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia.

Sahlgrenska Hospital: Intervention, cannulation of the groin and vascular surgery performed via catheters/guides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration.

Alingsås Hospital: Surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration.

Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory (STAI-S) and pain assessment using a numerical rating scale (NRS) from 0-11.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 65 years, planed surgery in local anesthesia/regional anesthesia

排除标准

  • dementia, unable to cooperate, cognitive impairment

结局指标

主要结局

propofol mg/kg

时间窗: during the surgery (90 minutes max)

dose of propofol given during surgery to the participant

次要结局

  • Surgeons satisfaction(Directly after surgery is finished)
  • Stress/anxiety(during the surgery (90 minutes max))
  • Nurse anesthetists experience, (questionnaire).(Directly after surgery is finished)
  • Level of pain(Directly after surgery is finished)

研究者

发起方
Pether Jildenstal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pether Jildenstal

Professor Pether Jildenstal Gothenburg University

Göteborg University

研究点 (4)

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