Longterm Effects of a Biofield Patch on Anxiety, Sleep, and Energy

Natural Immune Systems

Status: Not yet enrolling

Conditions: Anxiety; Sleep

Treatments: Device: Placebo patch; Device: Active dermal patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07353021

206-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Device: Active dermal patch

Group 2

Experimental group

Description:

Participants will use a placebo patch daily for 4 weeks. The placebo patch will look identical to an active patch, and will be blinded.

Treatment:

Device: Placebo patch