Health TrialsbyHealthPanel

MenoZen VR for Menopause Symptom Management

ConditionMenopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • MenoZen

    Device

    Participants will complete weekly self-administered virtual reality sessions via MenoZenVR, using a VR headset, for 8 consecutive weeks.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: MenoZenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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.

Time frame
8 weeks
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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