跳至主要内容
临床试验/NCT06227039
NCT06227039招募中不适用

Using Augmented Reality With Vibroacoustic Stimulation to Improve the Patient Experience During In-Office Otorhinolaryngology Procedures

University of Virginia2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Average pain experienced

研究概览

简要总结

In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Vibration and augmented reality (AR) can be used as non-pharmacologic treatment options to treat patient anxiety and pain by using the physiology proposed by the gate-way theory of pain as well as distraction. This study seeks to compare anxiety and pain perception with patient reported survey data, as well as physiologic indicators of stress such as heart rate variability (HRV) within patients undergoing IOPs in a laryngology office with and without vibration and AR treatment.

详细描述

In-office procedures (IOPs) represent a cost-effective and safe alternative to operating room procedures for a myriad of disease processes across medical and surgical specialties. IOPs are performed under local anesthetic without general anesthesia or sedation, resulting in faster and often safer procedures by eliminating risks associated with general anesthesia. IOPs are primarily limited by patient tolerance, as there is a lack of currently available non-pharmacologic treatment options for patient anxiety, stress, discomfort, and pain during these procedures.

The Gate Control Theory of Pain postulates that only a limited amount of simultaneous sensory stimuli can be processed by the central nervous system and therefore non-painful stimuli, such as vibration or virtual distraction (i.e. virtual or augmented reality), can eliminate or lessen the perception of concurrent painful stimuli. The use of these non-painful stimuli has been shown to have clinical utility in the setting of procedures such as percutaneous injections and wound dressing changes.

However, the coupling of multiple sensory distraction techniques has not been described for IOPs. Furthermore, no investigation of sensory distraction techniques to reduce patient discomfort within the field of otolaryngology has been conducted. The focus of the proposed project is to improve patient experience during IOPs by coupling a novel vibroacoustic stimulation device with original AR software applications.

In-office otolaryngology procedures specifically involve using a rigid endoscope or a flexible nasolarynogoscopy to visualize the inside of a patient nose, sinus, posterior oropharynx, and vocal cords. Using these imaging modalities, awake, in-office procedures can be performed. However, these procedures are often very uncomfortable and anxiety producing.

The goal of the study is to determine whether or not wearing an augmented reality headset with a novel game and vibroacoustic simulation device can help reduce anxiety and improve the patient experience of in-office otolaryngology procedures. The device consists of an augmented reality headset worn by the patient, a vibration device that is applied to the patient's neck to help reduce the sensation of the procedure, and a clicker that allows the patient to interact with the augmented reality game environment.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing office-based laryngology procedure performed at home institution.

排除标准

  • 未提供

结局指标

主要结局

Average pain experienced

时间窗: measured post-treatment (1 hr).

Visual analog scale rating of average perceived pain during procedure

Pain nervousness experienced

时间窗: measured post-treatment (1 hr).

Visual analog scale rating of how nervous about pain patient was during procedure

Max pain experienced

时间窗: measured post-treatment (1 hr).

Visual analog scale rating of max perceived pain during procedure

Change in heart rate variability during procedure

时间窗: calculated post-treatment (1 hr).

Difference between heart rate variability during procedure compared with pre-procedure

Change in average heart rate

时间窗: calculated post-treatment (1 hr).

Difference between average heart rate during procedure compared with pre-procedure

Time spent thinking about pain

时间窗: measured post-treatment (1 hr).

Visual analog scale rating of percent of time spent thinking about pain during procedure

Change in maximum heart rate

时间窗: calculated post-treatment (1 hr).

Difference between maximum heart rate during procedure compared with pre-procedure

次要结局

  • Pain catastrophizing score(calculated pre-procedure (1 hr).)
  • Change is STAI score(calculated post-procedure (1 hr).)
  • Patient satisfaction(measured post-treatment (1 hr).)

研究者

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

James Daniero, MD

Associate Professor, Division Director, Laryngology and Voice Care

University of Virginia

研究点 (2)

Loading locations...

相似试验