mindvybe Continuous Feedback - Pre-Session Questionnaire

Informed Consent Form
Purpose of the Study: You are invited to participate in a research study evaluating the effects of the mindvybe™ Vagus Nerve Stimulation Device on mood, stress, well-being, physical comfort, and mental clarity. This study involves continuous data collection to gather insights into the device’s effects.

Participation Details:
- Participation is completely voluntary.
- You must be 18 years or older to participate.
- Your involvement consists of answering one questionnaire before each session and one immediately after.
- No compensation is provided for participation.
Confidentiality: All collected data will be anonymized and analyzed in grouped form, ensuring your privacy is protected.

Consent: By submitting this form, you acknowledge that you have read and understood the information provided. You voluntarily agree to participate in the study.
Pre-Session Questionnaire
Name

First NameLast Name
Date of Birth

MonthDayYear
Date
Email
example@example.com
Sex
How long have you been using the mindvybe™ device?
How frequently do you use the mindvybe™ device?
Instructions:

* Read Questions Carefully: Focus on different well-being aspects, like emotions, anxiety, stress, and physical comfort.

* Reflect on Your State: Consider your current feelings and physical sensations.

* Use the 0 to 10 Scale: Rate experiences from 0 (most negative) to 10 (most positive).

* Be Honest: There are no right or wrong answers; your true responses help assess therapy effectiveness.

* Estimate if Unsure: If exact feelings are hard to pinpoint, estimate.
1. How would you rate your current state of mind (emotional state)?

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1 is very negative emotional state, 10 is very positive emotional state
2. How would you rate your current level of anxiety?

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1 is no anxiety, 10 is extreme anxiety
3. How would you rate your current level of stress?

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1 is no stress, 10 is extreme stress
4. How relaxed do you feel at this moment?

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1 is not relaxed at all, 10 is completely relaxed
5. How would you rate your level of mental clarity right now?

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1 is completely foggy, 10 is perfectly clear
6. How fatigued do you feel right now?

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1 is no fatigue, 10 is extreme fatigue
7. How would you rate your energy level right now?

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1 is completely drained, 10 is fully energized
8. How would you rate your level of brain fog right now?

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1 is No brain fog, 10 is Severe brain fog
9. How would you rate your current level of physical comfort?

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1 is feeling significant physical discomfort, 10 is feeling complete physical comfort
10. How would you rate your overall sense of well-being at this moment?

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1 is poor overall well-being, 10 is excellent overall well-being
11. How would you rate your mood at this moment?

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1 is extremely low mood , 10 is extremelly good mood
12. How would you rate your current level of focus and concentration?

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1 is no focus; completely distracted, 10 is fully focused; excellent concentration
Should be Empty:

Informed Consent Form

Pre-Session Questionnaire