NCT07633743招募中不适用
MenoZen VR for Menopause Symptom Management: Phase 2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in frequency of hot flashes
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.
研究组 & 干预措施
MenoZen
Experimental
Menopausal women will participate in weekly virtual reality sessions using the MenoZen VR program.
干预措施: MenoZen (Device)
结局指标
主要结局
Change in frequency of hot flashes
时间窗: Baseline, 8 weeks
Change in frequency of hot flashes will be assessed using the Hot Flash Daily Diary (HFDD). Participants will track the number of hot flashes experienced daily.
Change in severity of hot flashes
时间窗: Baseline, 8 weeks
Change in severity of hot flashes will be assessed using the Hot Flash Daily Diary (HFDD). Participants will rate the type and severity of symptoms of each hot flash on a scale of mild, moderate, severe, and very severe.
次要结局
- Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score(Baseline, 8 weeks)
- Change in Menopause Rating Scale (MRS) score(Baseline, 8 weeks)
- System Usability Scale (SUS) score(8 weeks)
- Change in Simulator Sickness Questionnaire (SSQ) score(Baseline, 8 weeks)
- Change in PROMIS Sleep Disturbance short-form score(Baseline, 8 weeks)
- Change in PROMIS Depression short-form score(Baseline, 8 weeks)
- Change in PROMIS Anxiety short-form score(Baseline, 8 weeks)
研究者
Chrisandra L. Shufelt, MD
Principal Investigator
Mayo Clinic
研究点 (2)
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