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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.
Mayo Clinic
Jacksonville, Florida, United States
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.
Time frame: 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.
Time frame: Baseline, 8 weeks
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).
Time frame: 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).
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks