Menopause
Conditions
Brief summary
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.
Interventions
DEVICEMenoZen
Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of hot flashes | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score | Baseline, 8 weeks | The Menopause-specific Quality of Life (MENQOL) questionnaire evaluates how menopausal symptoms affect a woman's daily life. It consists of 29 items categorized into four domains: vasomotor symptoms, psychosocial symptoms, physical symptoms, and sexual symptoms. Participants indicate whether they have experienced each symptom in the past week and rate to what extent each symptom has troubled them on a 7-point Likert scale (0 = not at all bothered; 6 = extremely bothered). Total score ranges from 0 (asymptomatic) to 232 (extremely troublesome). |
| Change in Menopause Rating Scale (MRS) score | Baseline, 8 weeks | The Menopause Rating Scale (MRS) is an 11 item questionnaire that evaluates severity of menopause symptoms. Participants indicate the severity of each symptom on a 5-point Likert scale (0 = none; 4 = very severe) Total score ranges from 0 (no symptoms) to 44 (very severe symptoms). |
| System Usability Scale (SUS) score | 8 weeks | The System Usability Scale is a 10 item questionnaire that evaluates user satisfaction. Participants answer questions about the VR program on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree). Total score ranges from 10 to 50, with higher scores indicating a greater level of overall satisfaction. |
| Change in Simulator Sickness Questionnaire (SSQ) score | Baseline, 8 weeks | The Simulator Sickness Questionnaire is a 16 item questionnaire assessing the severity of symptoms that may occur due to exposure to a VR environment. Participants answer questions on a 4-point Likert scale (1 = none; 4 = severe). Total score ranges from 16 to 64, with higher scores indicating more severe symptoms. |
| Change in PROMIS Sleep Disturbance short-form score | Baseline, 8 weeks | The PROMIS Sleep Disturbance short-form is an 8 item questionnaire that assesses perceived sleep quality and sleep-related impairment over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = very good; 5 = very poor), with higher scores indicating worse quality of sleep. |
| Change in PROMIS Depression short-form score | Baseline, 8 weeks | The PROMIS Depression short-form is an 8 item questionnaire that assesses perceived depression related emotional distress over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = never; 5 = always), with higher scores indicating more severe symptoms of depression. |
| Change in PROMIS Anxiety short-form score | Baseline, 8 weeks | The PROMIS Anxiety short-form is an 8 item questionnaire that assesses perceived anxiety related emotional distress over the last 7 days. Participants answer questions on a 5-point Likert scale (1 = never; 5 = always), with higher scores indicating more severe symptoms of anxiety. |
Countries
United States
Contacts
CONTACTLauren Uy
PRINCIPAL_INVESTIGATORChrisandra L. Shufelt, MD, MS
Mayo Clinic
PRINCIPAL_INVESTIGATORStephanie S. Faubion, MD, MBA
Mayo Clinic
Outcome results
None listed