Health TrialsbyHealthPanel

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

ConditionsAnxietySleep
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNatural Immune Systems Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active dermal patch

    Device

    Non-transdermal patch

  • Placebo patch

    Device

    Non-transdermal patch

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Secondary outcomes

1

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.

Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Other outcomes

1

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.

Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
2

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.

Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
3

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

Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Natural Immune Systems Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: