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临床试验/NCT04721587
NCT04721587已完成不适用

Effectiveness of Virtual Reality as a Pain and Anxiety Distraction Strategy on Office Hysteroscopy

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年2月18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
160
试验地点
1
主要终点
Pain score

研究概览

简要总结

Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. The "see and treat" strategy allows diagnosis and treatment in the same surgical act, and gives the technique a high resolution capacity, reducing the number of procedures the patient must undergo. The technological development of instruments has made it possible to have small-caliber endoscopic systems that have made this technique possible in an outpatient setting. Outpatient management allows patients to avoid the possible risks and inconveniences associated with the surgical environment, such as the waiting list and the need for anesthesia, as well as an earlier return to their activities of daily life. Despite the high resolution rates, a not inconsiderable percentage of women experience anxiety or pain during outpatient hysteroscopy, and this is the leading cause of treatment failure. In order to improve the tolerance and comfort of the patient, the usefulness of various strategies, both pharmacological and non-pharmacological, has been evaluated for pain reduction, with different results.

Virtual Reality (VR) has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental processes, chronic pruritus or venipuncture. There is no published study to our knowledge that evaluates the usefulness of VR in reducing the levels of anxiety and pain perceived during a hysteroscopic procedure.

The working hypothesis to be evaluated with this study is that the use of a VR device with reproduction of relaxing and distraction environments reduces the perception of pain and anxiety of the patient during an outpatient hysteroscopy.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being over 18 years
  • Understand and accept the study procedures
  • Sign the informed consent.
  • Indication of outpatient hysteroscopy according to the care protocols of the center
  • Not taking drugs for the treatment of anxiety.

排除标准

  • Not being able to understand the nature of the study and / or the procedures to be followed
  • Not signing the informed consent
  • Be under the age of 18
  • Pregnancy
  • Being diagnosed with anxiety disorder or being treated with anxiolytics
  • Patients suffering from vertigo
  • Patients with epilepsy
  • Active ear infection
  • Patients with diagnosed hypertension
  • Patients with cardiovascular disease
  • Patients with psychosis or severe mental illness

结局指标

主要结局

Pain score

时间窗: Intraprocedure

Decrease of 1 point or more in the level of pain measured by an 11-point visual analog scale, a validity scale that comprises 11 consecutive values from 0 to 10, with "0" corresponding to no pain and "10" to worst pain imaginable.

次要结局

  • Skin conductace(Intraprocedure)
  • Heart Rate(Intraprocedure)
  • Blood Pressure(Intraprocedure)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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