Stress Clinical Trial
Official title:
Randomized, Prospective, Sham-controlled, Blinded, Cross-over Clinical Study of the Effect of the Virtual Reality (VR) Technology on Recovery of Indicators of the Autonomic Nervous System in Healthy Volunteers Affected by Moderate Stress
Verified date | April 2019 |
Source | Pure Purr LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study assess the effect of the VR technology (Pure Purr technology) on the recovery of
the autonomic nervous system in healthy volunteers affected by moderate stress. Study subject
randomized into two groups: in Group 1 volunteers first be tested with the VR headset A, and
during the next visit- headset B. Group 2 volunteers first be tested with the VR headset B,
and during the next visit- headset A. Before, after and during VR session was conducted
stress modulation and ECG recording.
The Pure Purr technology combines several audio and visual stimuli aimed at activation of the
parasympathetic nervous system. Therefore, this study will investigate the effect of this
technology on the recovery of autonomic nervous system performance after moderate stress.
Status | Completed |
Enrollment | 94 |
Est. completion date | November 14, 2018 |
Est. primary completion date | November 14, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Females and males 20-60 years old; 2. Volunteers have no history of cardiovascular diseases; 3. Volunteers have no essential abnormalities on the ECG; 4. Normal or moderate level of situational anxiety based on the Spielberger State-Trait Anxiety Inventory (STAI); 5. Signed Informed Consent Form for participation in the study. Exclusion Criteria: 1. Intolerance to the VR technology; 2. HR 110 bpm or below 50 bpm; 3. RR above 23 breaths per minute; 4. Abuse of alcohol, psychotropic substances and narcotic agents; 5. Smoking more than 100 cigarettes a week; 6. Administration of medicinal products for the treatment of cardiovascular and nervous system diseases 3 days prior to participation in the study; 7. Drinking tonics and energy drinks for at least 2 hours prior to participation in the study; 8. Severe or acute forms of respiratory, urogenital, gastrointestinal, haematological, metabolic, endocrine, or neurological diseases; 9. Mental disorders, which, in the opinion of the investigator, may distort the results of the study; 10. Participation in any clinical study over the last 3 months prior to enrolment to the study; 11. Parkinson's disease, Parkinson's symptoms, tremor, restless leg syndrome, and other motility disorders; 12. Pregnancy; 13. Any disease of the thyroid gland. |
Country | Name | City | State |
---|---|---|---|
Ukraine | Doctor Sam Medical Network | Kyiv | Kyiv Region |
Lead Sponsor | Collaborator |
---|---|
Pure Purr LLC | Pharmaxi LLC |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Power in high frequency range (HF) [ms2] | Change from Power in high frequency range (HF) [ms2] at 5 minutes before and after VR technology using | The outcome measure will be assessed between two visits with minimum interval 24 up to seven days | |
Secondary | The square root of the mean of the sum of the squares of differences between adjacent NN intervals (rMSSD), [ms] | Change from rMSSD variable at 5 minutes before and after VR technology using | The outcome measure will be assessed between two visits with minimum interval 24 up to seven days | |
Secondary | Standard deviation of all NN intervals (SDNN), [ms] | Change from SDNN variable at 5 minutes before and after VR technology using | The outcome measure will be assessed between two visits with minimum interval 24 up to seven days | |
Secondary | Ratio Power in low frequency range [ms2]/ Power in high frequency range [ms2] (Ratio LF [ms2]/HF [ms2]) | Change from Ratio LF [ms2]/HF [ms2] at 5 minutes before and after VR technology using | The outcome measure will be assessed between two visits with minimum interval 24 up to seven days | |
Secondary | Total power (TP), [ms2] | Change from Total power (TP) variable at 5 minutes before and after VR technology using | The outcome measure will be assessed between two visits with minimum interval 24 up to seven days | |
Secondary | Heart Rate (HR) variable. | Change from Heart Rate (HR) variable at 5 minutes before and after VR technology using | The outcome measure will be assessed between two visits with minimum interval 24 up to seven days | |
Secondary | BP (both systolic and diastolic blood pressure) variable. | Change from systolic and diastolic blood pressure at 5 minutes before and after VR technology using | The outcome measure will be assessed between two visits with minimum interval 24 up to seven days | |
Secondary | Spielberger state-trait anxiety inventory (STAI) variable. | Change from STAI variable at 5 minutes before and after VR technology using. STAI-Examination of the level of situational anxiety. Statement for ?xamination: Calm down Safe Tense Annoyed Comfortable Upset Concerned with future misfortunes Relaxed Anguished At ease Self-confidence Nervous Restless Downhearted Rested Satisfied Concerned Stunned Happy I fell good The range for each subscale from 1 to 4 point. Processing of results: Calculate the total score based on answers given by volunteers. While interpreting the results, use the following levels of anxiety: up to 30 points — low, 31 - 44 points — moderate; 45 and more — high. |
The outcome measure will be assessed between two visits with minimum interval 24 up to seven days |
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