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The goal for this clinical trial is to compare an active biofield non-transdermal skin patch to a placebo patch in people who frequently experience anxiety.
The goal for this clinical trial is to document effects of a photobiomodulating non-transdermal patch compared to a placebo patch, in a randomized double-blind placebo-controlled design.
Data on stress and anxiety levels will be collected using the GAD and OASIS questionnaires as well as the Warwick-Edinburgh Mental Wellbeing Scales collected. The data collected will show whether the daily use of the patch leads to a change in general self-reported stress and anxiety levels. Data on energy levels will be collected using a Wellness questionnaire. Data on sleep quality will be collected using the Leeds sleep evaluation questionnaire, to document whether using the active patch impacts self-reported sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will use an active biofield patch daily for 4 weeks. The active biofield patch will look identical to a placebo patch, and will be blinded. |
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| Group 2 | Experimental | Participants will use a placebo patch daily for 4 weeks. The placebo patch will look identical to an active patch, and will be blinded. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active dermal patch | Device | Non-transdermal patch |
| |
| Placebo patch |
| Measure | Description | Time Frame |
|---|---|---|
| General Anxiety Disorder 7 (GAD 7) Questionnaire | Change from baseline in anxiety score using the General Anxiety Disorder 7-item. The General Anxiety Disorder-7 scale evaluates anxiety severity using scores ranging from 0-21, where higher scores indicate higher anxiety severity. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire | Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) score. The Overall Anxiety Severity and Impairment scale evaluates anxiety and impact on daily living in participants with a score between 0 and 25, where higher scores indicate higher anxiety severity and impact on daily living. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Warwick-Edinburgh Mental Wellbeing Scale | Changes from baseline in mental wellbeing using the Warwick-Edinburgh Mental Wellbeing scale. The Warwick-Edinburgh Mental Wellbeing scale evaluates self reported happiness and satisfaction as well as psychological functioning, good relationships with others, and self realization. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
Inclusion Criteria:
Healthy adults of all genders;
Age 18-75 years (inclusive);
BMI between 18.0 and 34.9 (inclusive)
Experiencing intermittent episodes of anxiety on a regular basis, leading to either avoiding specific situations, or experiencing stress both in anticipation of, and during such situations.
Specific situations that occur regularly that cause anxiety, for example:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gitte S Jensen, PhD | Contact | 541 882 0112 | Gitte@nislabs.com | |
| Alex Cruickshank | Contact | Alex@nislabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Randomized, double-blinded, placebo-controlled study design
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| Device |
Non-transdermal patch |
|
| Wellness Questionnaire | Change from baseline in wellness evaluated using a Wellness questionnaire. The Wellness questionnaire consists of 30 questions, generating scores for physical, mental functioning, emotional wellbeing, stress, social functioning, sleep, and energy/vitality, where higher scores reflect better wellness. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Leeds Sleep Questionnaire | Changes from baseline in sleep quality. The Leeds Sleep Evaluation Questionnaire is a 10 item linear-log scale based on questions across several domains of sleep, where higher scores reflect better sleep quality | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks. |