NCT07633743尚未招募不适用
MenoZen VR for Menopause Symptom Management: Phase 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The purpose of this research is to evaluate the feasibility, acceptability, tolerability, and clinical efficacy of MenoZen VR (virtual reality) for managing menopause symptoms in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women currently between 45-60 years of age;
- •Have moderate to severe VMS, defined as 28 or more hot flashes per week (including night sweats) and were sufficient severity to prompt them to seek therapeutic intervention;
- •Are English-speaking;
- •Able to participate fully in all aspects of the study;
- •Have understood and signed study informed consent;
- •Have access to a computer or smartphone and home Wi-Fi;
- •Willing to participate in weekly VR sessions for 8 weeks.
排除标准
- •Women receiving systemic menopause hormonal therapy (progesterone, testosterone, estrogen). Low-dose topical vaginal estrogen is okay;
- •Women receiving non-hormonal therapy for the management of hot flashes (fezolinetant or elinzanetant, any SSRI/SNRI, oxybytunin, and/or gabapentin being prescribed for hot flashes, if for other reasons and still with hot flashes then okay);
- •Women receiving active cognitive behavioral therapy (CBT) for hot flashes. CBT for mood symptoms is okay;
- •Have a known, active, untreated clinically significant psychiatric condition (severe depression, psychosis, bipolar disorder, or severe depression);
- •Have severe visual, auditory, or vestibular impairments that may interfere with VR use;
- •Have a facial/head deformity that will prohibit the wearing of a VR head mounted displace (HMD);
- •Self-reported history of acute and/or severe motion sickness;
- •Have had a seizure in the past year;
- •Concurrently enrolled in another intervention trial for menopause symptoms;
- •Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
研究者
Chrisandra L. Shufelt, MD
Principal Investigator
Mayo Clinic
研究点 (1)
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