Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.

Schlotterbeck Hervé1 个研究点分布在 1 个国家目标入组 150 人2024年3月29日

适应症Virtual Reality Medical Device Local Anesthesia Pain

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Virtual Reality
发起方: Schlotterbeck Hervé
入组人数: 150
试验地点: 1
主要终点: Global pain intensity experienced during the procedure.
状态: 招募中
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.

注册库

clinicaltrials.gov

开始日期

2024年3月29日

结束日期

2026年12月31日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Schlotterbeck Hervé

责任方

Sponsor Investigator

主要研究者

Schlotterbeck Hervé

Principal Investigator

Ente Ospedaliero Cantonale, Bellinzona

入排标准

入选标准

•Patients over 18 year old,
•Patients who signed the consent form and accepted to participate to the trial,
•New cardiac electronic device implantation or cardiac electronic device battery change,
•Surgical procedure planned in ambulatory care.

排除标准

•Communication limitations,
•Surgical procedure planned in sedation or narcosis,
•Severe sensorial deficits (visual, auditory),
•Claustrophobia,
•Known motion sickness,
•Patient isolated or with contact precautions,
•Known or anticipated psychiatric diseases,
•Patient known for epilepsia,
•Opened scar and or ongoing infection at the level of the face and/or eyes,
•Patient evaluated non suitable for the study by the surgeon, cardiologist or anesthetist.

结局指标

主要结局

Global pain intensity experienced during the procedure.

时间窗: At the end of surgery

Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).

次要结局

Need for supplementary sedation and/or analgesia during the procedure.(At the end of surgery)
Total dose of local anaesthetic used during the procedure.(At the end of surgery)
Change in anesthetic strategy during procedure.(At the end of surgery)
Global anxiety intensity experienced during the procedure.(At the end of surgery)
Patient's perceived procedure duration.(At the end of surgery)
Incidence of hypotensive or hypoxic events during procedure.(At the end of surgery)
Interruption of virtual reality experience during the procedure.(At the end of surgery)
Patient's comfort during the procedure assessed by the surgeon and cardiologist.(At the end of surgery)
Maximal systolic arterial blood pressure.(At the end of surgery)
Incidence of motion sickness during the virtual reality experience.(At patient discharge (or at a maximum of 4 hours after the end of surgery))
Intra- and post-procedure complications.(At patient discharge (or at a maximum of 4 hours after the end of surgery))
Overall patient's comfort and satisfaction experienced during the procedure.(At patient discharge (or at a maximum of 4 hours after the end of surgery))