Comparisons Between Virtual Reality and Hypno-Virtual Reality for Procedural Pain and Anxiety During a Diagnostic Hysteroscopy: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Patient's acceptability towards the intervention
研究概览
简要总结
Background: Hysteroscopy (HSC) is a minimally invasive gynecological procedure that is considered to be the gold standard for diagnosing and treating intrauterine pathologies. In recent years, its use in outpatient settings for diagnosis has grown significantly due to its efficiency, low complication rate, and good patient acceptability. However, many patients still report significant pain and anxiety during the procedure. Despite advances in instrumentation and technique, pain remains a key reason for procedural failure, often worsened by preprocedural anxiety. While pharmacological strategies can be used to address this issue, they are not always suitable due to lack of effectiveness or feasibility. As a result, non-pharmacological approaches such as virtual reality (VR) and hypnosis are being increasingly explored.
Objective: This pilot study aims to assess the feasibility, acceptability and preliminary effects of immersive virtual reality (IVR) and Hypno-VR (HVR) in managing pain and anxiety during diagnostic HSC.
Methods: This pilot randomized controlled trial (RCT) will follow a three-arm parallel design to compare: 1- standard care, 2- IVR + standard care, and 3- HVR + standard care, during diagnostic HSC. A total of 45 participants (15/arm) will be recruited from the CHU Sainte-Justine's gynecology clinic and randomly assigned to one of the three groups. Primary outcomes will concern feasibility and acceptability including satisfaction of both patients and healthcare professionals. Secondary outcomes will assess self-reported pain and anxiety, physiological responses, procedure duration, procedure failure, and conversion rate from the "no-touch" vaginoscopy technique to traditional tools like the speculum and tenaculum. Demographic characteristics will also be explored as potential moderators of intervention effectiveness.
Results/Conclusion: This pilot study will provide preliminary data on the effects of IVR and HVR on procedural pain and anxiety during diagnostic HSC. It will also assess the feasibility and the acceptability of integrating these interventions into an outpatient setting. The findings will provide essential data in preparation for a larger clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Minimum 18 years old
- •Speak and read French or English
- •Scheduled to undergo a diagnostic hysteroscopy
排除标准
- •Having a diagnosis of epilepsy
- •Recent ophthalmologic surgery (< 1month) or any ophtalmologic problems that could interfere with the patient's ability to use the VR technology
研究组 & 干预措施
Usual Care Treatment
Standard protocol offered at CHU Ste-Justine's Hospital before a diagnostic hysteroscopy procedure
干预措施: Usual Care Group (Other)
Immersive Virtual Reality Distraction (IVR)
Use of IVR during diagnostic hysteroscopy
干预措施: Immersive Virtual Reality Distraction (IVR) (Device)
Hypno-Virtual Reality distraction (HVR)
Use of HVR during diagnostic hysteroscopy
干预措施: Hypno-Virtual Reality Distraction (HVR) (Device)
结局指标
主要结局
Patient's acceptability towards the intervention
时间窗: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)
The patient's acceptability towards the intervention will be assessed using the Treatment Acceptability \& Preference (TAP) questionnaire: 10 questions (6 Likert-scale items from 0 to 4 and 4 open-ended questions). These questions focus on acceptability, satisfaction, ease of use, perceptions, and suggestions for improvement (T2).
The patient's satisfaction level
时间窗: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)
The patient's satisfaction level towards the intervention will be assessed using a Verbal Numerical Rating Scale (VNRS), ranging from 0 to 10, where 0 indicates "very dissatisfied" and 10 indicates "very satisfied." Patients will be asked the following question: "Considering anxiety relief, pain relief, side effects, and emotional recovery, how satisfied were you with the treatments you received during the procedure?" (T2).
Completion rate of the planned intervention
时间窗: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)
Completion rate of the planned intervention will be assessed as the proportion of participants who complete their allocated intervention out of the total number of participants randomized.
The healthcare professionals' satisfaction level
时间窗: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)
The healthcare professionals' satisfaction level will be assessed using a customized questionnaire comprising 7-10 items, depending on the intervention used. Each item will be rated on a four-point Likert scale, ranging from "Strongly agree" to "Strongly disagree," evaluating their satisfaction with the intervention and its perceived impact on the procedure (T2).
Recruitment rate
时间窗: To be reported right before the procedure, at baseline (T0)
Recruitment rate will be assessed as the proportion of patients who consent to participate out of the total number of HSC procedures performed.
次要结局
- Change in heart rate(Heart rate (beats per minute) will be measured right before the procedure, at baseline (T0) and about 2 minutes after the end of the hysteroscopy procedure (T2).)
- Anxiety intensity(Measurements will be taken at baseline (T0), 2 minutes after the intervention (T2), and one week later (T3). The T3 evaluation will be conducted by a research assistant through the participant's preferred mode of communication.)
- Failure of hysteroscopy(To be reported during the procedure (T1))
- Required time for the procedure(To be reported during the procedure (T1))
- Pain intensity(Assessments will be conducted at baseline (T0), 2 minutes after the intervention (T2), and one week post-intervention (T3). The T3 assessment will be performed by a research assistant.)
研究者
Sylvie Le May
Principal investigator
St. Justine's Hospital