Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenoZen | Experimental | Menopausal women will participate in weekly virtual reality sessions using the MenoZen VR program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenoZen | Device | Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of hot flashes | 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. | Baseline, 8 weeks |
| Change in severity of hot flashes | 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. | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Menopause-specific Quality of Life (MENQOL) Questionnaire score | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Uy | Contact | 904-953-5337 | Uy.Lauren@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chrisandra L. Shufelt, MD, MS | Mayo Clinic | Principal Investigator |
| Stephanie S. Faubion, MD, MBA | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 8 weeks |
| Change in Menopause Rating Scale (MRS) score | 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). | Baseline, 8 weeks |
| System Usability Scale (SUS) score | 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. | 8 weeks |
| Change in Simulator Sickness Questionnaire (SSQ) score | 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. | Baseline, 8 weeks |
| Change in PROMIS Sleep Disturbance short-form score | 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. | Baseline, 8 weeks |
| Change in PROMIS Depression short-form score | 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. | Baseline, 8 weeks |
| Change in PROMIS Anxiety short-form score | 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. | Baseline, 8 weeks |