Longterm Effects of a Biofield Patch on Anxiety, Sleep, and Energy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active dermal patch, Placebo patch.
- Who it may be relevant to
- Registry conditions: Anxiety, Sleep. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Trial on Long-Term Effects of a Biofield Patch on Anxiety, Sleep, and Energy. A Randomized Double-Blind Placebo-Controlled 4-week Trial.
Overview
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.
Detailed description
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.
Interventions
- Device Active dermal patch
Non-transdermal patch - Device Placebo patch
Non-transdermal patch
Primary outcome measures
- General Anxiety Disorder 7 (GAD 7) Questionnaire [Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks]
Secondary outcome measures (1)
- Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire [Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks]
Eligibility criteria
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:
- Performing specific tasks at work or at home;
- Inter-personal conflicts at work or at home;
- Driving or commuting;
- Fearful and worrying about one's own situation (such as paying bills);
- Worrying about ongoing problems experienced by others.
Exclusion criteria
- Cancer during past 12 months;
- Chemotherapy during past 12 months;
- Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication;
- Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
- Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change;
- Serious active illness within past 6 months;
- People who are pregnant, nursing, or trying to become pregnant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- NIS Labs — Klamath Falls
Identifiers
NCT: NCT07353021 · 206-008