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| Name | Class |
|---|---|
| Biofortis Innovation Services | INDUSTRY |
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The goal of this clinical trial is to compare the frequency and duration of meditation in generally healthy adults between:
Participants will be encouraged to meditate every day in either way listed above and asked to complete Daily Study Intervention Recall for 8 weeks.
Additionally, self-reported aspects of stress and mood will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A novel mindfulness approach | Experimental |
| |
| Breathing meditation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation with guided tea consumption | Other | Mindful consumption of tea along with an approximately 10-min guide |
|
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of meditation during the study | Frequency will be expressed as days whereby a meditation day is defined as a day where subjects completed at least one meditation session. Data will be obtained from the Daily Study Intervention Recall. | 8 weeks |
| The total duration of time spent in meditation during the study | Data will be obtained from the Daily Study Intervention Recall. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The average duration of time in meditation calculated weekly | weekly over 8 weeks | |
| Changes from baseline (screening) in the total score of the Perceived Stress Scale | Five-point scale from 0 (never) to 4 (very often). The total score ranges from 0 to 40 where higher values mean higher stress levels |
| Measure | Description | Time Frame |
|---|---|---|
| Survey related to meditation benefits | On Days 28 and 55 | |
| Product/Program Satisfaction Survey | On Days 0, 28 and 55 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Innovation Services | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39657179 | Derived | Tanaka-Kanegae R, Yamada K, Cook CM, Blonquist TM, Taggart KD, Hamada K. Feasibility and Efficacy of a Novel Mindfulness App Used With Matcha Green Tea in Generally Healthy Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Dec 10;12:e63078. doi: 10.2196/63078. |
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| Breathing meditation | Other | 10-min breathing meditation |
|
| On Days 28 and 55 |
| Changes in the Mood Scale metrics |
The first ten items will be answered on a 6-point scale from 0 (not at all) to 5 (extremely). The last four metrics will be calculated according to the Two-Dimensional Mood Scale | On Days 0 and 55 |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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