バイオフィールドパッチの不安、睡眠、エネルギーに対する長期的効果
不安、睡眠、エネルギーに対するバイオフィールドパッチの長期効果に関する臨床試験。無作為化二重盲検プラセボ対照4週間試験。
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alex Cruickshank
- メール：Alex@nislabs.com
研究連絡先のバックアップ
- 名前：Gitte S Jensen, PhD
- 電話番号：541 882 0112
- メール：Gitte@nislabs.com
研究場所
-
-
Oregon
-
Klamath Falls、Oregon、アメリカ、97601
- 募集
- NIS Labs
-
コンタクト：
- Gitte S. Jensen, PhD
- 電話番号：5418840112
- メール：gitte@nislabs.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group 1
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. |
Non-transdermal patch |
|
実験的：Group 2
Participants will use a placebo patch daily for 4 weeks. The placebo patch will look identical to an active patch, and will be blinded. |
Non-transdermal patch |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
General Anxiety Disorder 7 (GAD 7) Questionnaire
時間枠：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire
時間枠：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Warwick-Edinburgh Mental Wellbeing Scale
時間枠：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
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
|
|
Wellness Questionnaire
時間枠：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
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
時間枠：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks.
|
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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。