Virtual Reality as a Tool to Reduce Pain, Anxiety, and Stress in Patients Undergoing Hysterosalpingo-Foam Sonography (HyFoSy): A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Maximum Procedural Pain Score on the Visual Analog Scale
研究概览
简要总结
This randomized controlled study will evaluate whether virtual reality (VR) reduces procedural pain and anxiety in women undergoing hysterosalpingo-foam sonography (HyFoSy), a minimally invasive ultrasound-based procedure used to assess uterine anatomy and fallopian tube patency. Participants will be randomly assigned to either a VR intervention group or a standard-care control group. The primary outcome will be maximum pain experienced during the procedure, assessed using a Visual Analog Scale (VAS). Secondary outcomes will include state anxiety, heart rate variability (as a physiological measure of autonomic response to procedural stress) and patient satisfaction
详细描述
Hysterosalpingo-foam sonography (HyFoSy) is a minimally invasive ultrasound-based procedure used to evaluate the uterine cavity and fallopian tube patency as part of the infertility evaluation. Although HyFoSy is generally well tolerated and is associated with less pain than hysterosalpingography, some women experience procedural pain and anxiety.
Pain and anxiety associated with gynecological procedures may negatively affect the patient experience and may contribute to avoidance of future gynecological examinations and procedures. Anxiety may also contribute to cervical spasm and potentially increase the technical difficulty of the procedure.
Virtual reality (VR) is a non-pharmacological intervention that has been investigated for reducing pain, anxiety, and stress during various medical procedures. Previous studies in obstetrics and gynecology have reported beneficial effects of VR during procedures including amniocentesis, hysteroscopy, and intrauterine insemination. However, the effect of VR during HyFoSy has not been adequately studied.
The purpose of this randomized controlled study is to evaluate the effect of VR on procedural pain and anxiety during HyFoSy compared with standard care. The primary outcome will be maximum procedural pain assessed using a Visual Analog Scale (VAS). State anxiety will be assessed using the State subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S). Physiological response to procedural stress will be assessed using continuous heart rate and heart rate variability (HRV) monitoring.
Participants randomized to the VR intervention group will use VR goggles beginning approximately 5 minutes before the HyFoSy procedure and throughout the procedure. Participants will be able to select their preferred relaxing VR content. Participants randomized to the standard-care group will rest for approximately 5 minutes before the procedure and will undergo HyFoSy according to standard clinical practice without VR.
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
- 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
- 否
入选标准
- •Female participants aged 18 years or older. Undergoing HyFoSy as part of routine clinical care. Able to understand the study procedures and provide written informed consent.
排除标准
- •Visual impairment preventing use of the VR device. Hearing impairment preventing use of the VR content. History of motion sickness. History of epilepsy. History of schizophrenia Use of analgesic or anxiolytic medication before the procedure, outside of regular ongoing treatment.
研究组 & 干预措施
Virtual Reality
Participants will use virtual reality goggles beginning approximately 5 minutes before the HyFoSy procedure and continuously throughout the procedure. Participants will be able to select their preferred relaxing VR content. Standard clinical care for HyFoSy will otherwise be provided
干预措施: virtual reality (Behavioral)
Standard Care
Participants will rest for approximately 5 minutes before the HyFoSy procedure and will undergo the procedure according to standard clinical practice without virtual reality intervention
干预措施: rest (Other)
结局指标
主要结局
Maximum Procedural Pain Score on the Visual Analog Scale
时间窗: Immediately after completion of the HyFoSy procedure
Maximum pain experienced by the participant during the HyFoSy procedure, assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. The maximum pain score reported during the procedure will be compared between the virtual reality and standard-care groups.
次要结局
- Change in State Anxiety Score on the STAI-S(From immediately before the HyFoSy procedure to immediately after the procedure)
- Change in Current Pain Score on the Visual Analog Scale(From immediately before to immediately after the HyFoSy procedure)
- Heart Rate During the HyFoSy Procedure(During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period)
- Heart Rate Variability: RMSSD(During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period)
- Heart Rate Variability: pNN50(During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period)
- Patient-Reported Satisfaction With the HyFoSy Procedure(Immediately after completion of the HyFoSy procedure)
- Physician-Rated Procedural Difficulty(Immediately after completion of the HyFoSy procedure)
- Successful Completion of the HyFoSy Procedure(Immediately after completion of the HyFoSy procedure)