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临床试验/NCT06877663
NCT06877663已完成不适用

Impact of Virtual Reality on Anxiety Management During Elective Surgery

University of Campania Luigi Vanvitelli1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
233
试验地点
1
主要终点
STAI score

研究概览

简要总结

The aim of this research is to assess and compare the effects of audiovisual content administered via specific Meta Quest 2 headsets on pre-surgical anxiety in patients undergoing elective surgical procedures and on procedure-related comfort.

详细描述

Preoperative anxiety is a very common condition in all individuals undergoing surgical procedures. On the day of the procedure, in fact, between 50% and 70% of patients experience anxiety, which usually peaks during anesthesia induction. The main concerns underlying pre-surgical anxiety include fear of surgical complications, worries about the duration of the procedure, the potential onset of subsequent disabilities, as well as concerns regarding general anesthesia and the associated loss of control. Additionally, a common fear is waking up and experiencing discomfort and pain during the procedure. More anxious patients are at greater risk of problems during anesthesia induction, difficulties in pain management, and a more challenging recovery. These frequent conditions highlight the need for interventions aimed at reducing preoperative anxiety.

Currently, the most common prevention/treatment for preoperative anxiety is a pharmacological approach. The pharmacological option includes sedatives and anxiolytic drugs, which, however, may cause adverse effects such as respiratory problems, drowsiness, interactions with anesthetic drugs, and prolonged recovery time. Therefore, non-pharmacological interventions are becoming increasingly common.

There are also other non-pharmacological approaches, although less widespread, including cognitive-behavioral therapy (the current gold-standard treatment for anxiety disorders), aromatherapy, and music therapy. Additionally, in pediatric surgery, audiovisual support has been tested as a means of reducing anxiety levels, particularly when focused on providing preoperative management information, administered 48 hours before the scheduled surgery. This practice has also been found to be more satisfactory than traditional play activities with toys.

Currently, several all-in-one virtual reality (VR) headsets are available on the market, capable of immersing an individual in an artificially constructed reality. Specifically, the Meta Quest 2 ™ headset (Meta®, Menlo Park, California, USA) explores VR on a standalone platform, with advanced privacy features to encrypt data and parental supervision tools to ensure appropriate content for all users. In the medical field, VR headsets have already been tested in rehabilitation, ophthalmology, and surgery as a therapeutic method for patients, as well as a fundamental tool for physician training.

The objective of this study is to evaluate the impact of VR on patients undergoing elective surgery in reducing preoperative anxiety and improving patient comfort.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigators and Outcome Assessor were all blinded to treatment allocation. Because the blinding of the operating surgeons was not feasible, they were not involved in the data collection and outcome assessment. Physicians in charge of patients' management were not involved in the operating room and were blinded to the device use. The data were collected and analyzed by physicians who were not involved in the patient's management during the study.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age >18 years
  • •Age <70 years
  • •Indication for elective surgery

排除标准

  • •Diagnosis of Anxiety Disorder, Major Depression, Personality Disorder, Bipolar Syndrome
  • •Substance abuse
  • •Inability to complete the study protocol
  • •Patients for whom the surgical procedure was not performed

研究组 & 干预措施

Virtual Reality Group

Experimental

Group A: Patients who will receive entertainment videos via VR headset in the preoperative room before surgery.

干预措施: Virtual Reality Device (Device)

Control Group

No Intervention

Group B: Patients who will receive standard preoperative care and will serve as the control group.

结局指标

主要结局

STAI score

时间窗: It will be administered at three different time points for both the control group (Group B) and the experimental Group A (screening, before surgery, and 48 hours after the operation) to quantify patient anxiety levels.

Assessment of the difference in State-Trait Anxiety Inventory (STAI; range 20-80; a higher score indicates a higher level of anxiety) score between the two groups at baseline, preoperatively, and postoperatively

次要结局

  • VAS scale(It will be evaluated at 12-24-48 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudio Gambardella

Associate Professor, MD, PhD

University of Campania Luigi Vanvitelli

研究点 (1)

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