Intervention Study to Measure the Effect on Perception of Pain and Anxiety in Women With Indication for Diagnostic Hysteroscopy Through the Use of Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
Randomized intervention trial with a calculated sample size of 90 women aged between 18 and 75 years and medical criteria for performing a diagnostic hysteroscopy according to the Gynecology and Obstetrics Spanish Society (SEGO).
Nowadays the investigators known that acute pain requires cognitive attention for its perception, a patient's state of anxiety depends on the subjective capacity to cope with the process and that environments created with virtual reality can cause a cognitive distraction that diminishes the perception of pain as well as a subjective psychological illusion that diminishes the anxiety that motivates the procedure.
For all the above, the investigators will study as a main objective the differences between the use of virtual reality through the use of virtual reality glasses "Oculus go model", to reduce the perception of pain and anxiety motivated by the performance of a outpatient hysteroscopy versus clinical practice. It is usual not to use analgesia, using the VAS pain scale and the STAI (State-Trait Anxiety Inventory) questionnaire to assess the state of anxiety before and after the test. In addition, as secondary objectives, the investigators will compare different aspects such as surgical time used, determination of vital signs, satisfaction studies ...
详细描述
A Cochrane review (included 32 clinical trials and 3304 patients) concluded that there was no effective and safe treatment for pain relief in patients undergoing outpatient hysteroscopy. In the same way, The Gynecology and Obstetrics Spanish Society (SEGO) discourages the routine use of analgesics prior to the test or the use of local anesthesia or sedation, since neither improves the pain nor the satisfaction of the patients in this type of test.
Nowadays, is knowed that acute pain requires cognitive attention for its perception, a patient's state of anxiety depends on the subjective capacity to cope with the process and that environments created with virtual reality can cause a cognitive distraction that diminishes the perception of pain as well as a subjective psychological illusion that diminishes the anxiety that motivates the procedure.
With all this, the investigators intend to assess through this study if patients with medical indication for diagnostic hysteroscopy can benefit from the use of Virtual Reality for the decrease in their perception of pain, anxiety or increase in the degree of satisfaction with their performance.
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- Design: Randomized intervention clinical trial
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- Sample: by contrast of hypothesis, a sample size of 90 women with an established medical indication for outpatient hysteroscopy was determined. They were randomized using excel software. As criteria of inclusion, those of SEGO with ages between 18 and 75 years were used. Criteria of exclusion those of the test, presenting some type of illness or disability that contraindicate the use of Virtual Reality (blindness, deafness, epilepsy, etc), voluntary wish of no inclusion or inability to understand the study.
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- Methodology:
- parameters to analyze:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with an established indication for diagnostic hysteroscopy according to the Spanish Society of Gynecology and Obstetrics (SEGO) criteria collected in its document of consensus, updated in 2013, with the title of "Hysteroscopy in consultation".
- •Age between 18 and 75 years.
- •Suitable cultural level for the understanding of the characteristics of the study.
- •Signature of informed consent.
排除标准
- •Not be within the criteria established by SEGO for the realization of a hysteroscopy diagnostic.
- •Existence of contraindication for hysteroscopy.
- •Present some type of disease or disability that can intervene in the object of the study: visual deficit, auditory or sensory severe, illnesses or mental syndromes.
- •Having suffered seizures, loss of knowledge, or other symptoms related to epileptic disorders that discourages the use of virtual reality glasses.
- •Women who cannot tolerate the pain at the beginning and during hysteroscopy.
- •Not signature of informed consent.
结局指标
主要结局
State-Trait Anxiety Inventory (STAI)
时间窗: Change from baseline STAI scale at 30 minutes.
State-Trait Anxiety Inventory (STAI): A psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety. Each measure has a different rating scale. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always.
Visual Analogue Scale (VAS)
时间窗: Change from baseline VAS at 30 minutes.
Visual Analogue Scale: A measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.This scale is between the values 0 to 10, being 0 the greatest pain possible and 10 the least pain. It is categorized into several sections, being intense pain 0-3, moderate pain 4-7 and low pain 8-10.
次要结局
- Systolic and Diastolic blood pressure(Changes of systolic and diastolic blood pressure from baseline at 30 minutes.)
- Oxygen saturation(Changes of oxygen saturation from baseline at 30 minutes.)
- Cardiac frequency(Changes of cardiac frequency from baseline at 30 minutes.)
研究者
David Varillas Delgado
Principal Investigator
Universidad Francisco de Vitoria