Clinical Trial on Long-Term Effects of a Biofield Patch on Anxiety, Sleep, and Energy. A Randomized Double-Blind Placebo-Controlled 4-week Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.