Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour

Study Overview
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Brief Summary
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In integrative medicine wraps are applied for different indications. In this study the effects of thorax with ginger and mustard flour are investigated under standardized conditions. Heart rate variability, well being, warmth distribution and respiratory activity of healthy subjects will be measured.

Detailed Description
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The purpose of this study is to investigate the effects of different thorax wraps in healthy subjects. Subjects undergo three different interventions (wraps with ginger flour, mustard flour or warm water (placebo)) on three different days. Heart rate variability and respiratory activity is measured for ten minutes before, during (up to 20 minutes) and for ten minutes after each thorax wrap. To investigate the effects on heat development and regulation, photos are taken with a thermographic infrared camera at various moments in time. Participants are asked to fill in questionnaires referring to their subjective perceptions of warmth, bodily warmth distribution and wellbeing. The order of the thorax wrap interventions is randomized.

Official Title
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Psychophysiological Efficacy of Thorax Wraps With Ginger or Mustard Flour in Comparison to Wraps With Warm Water in Healthy Subjects - a Randomized, Placebo-controlled, Three-armed Study With Cross-over Design

Conditions
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Healthy

Intervention / Treatment
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* Drug: Zingiberis Rhizoma plv.
* Drug: Sinapis nigrea semen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Exclusion Criteria: Inflectional disease with body temperature > 38 °C. Skin damage on the thorax area Known intolerance or hypersensitivity to mustard or ginger products. Heart failure. Asthma bronchiale. Taking medication with influence on heart rate variability ( mainly tricyclic antidepressants and beta blocker). Consumption of coffee or nicotine less than three hours before the intervention. Pregnancy. Deficient knowledge of the German language.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thorax wrap with ginger flour (Zingiberis Rhizoma plv.)<br>Thorax wrap with ginger flour, duration max. 20 minutes | Drug: Zingiberis Rhizoma plv.<br> <br> |
| Active Comparator: Thorax wrap with mustard flour (Sinapis nigrea semen)<br>Thorax wrap with mustard flour, duration max 20 minutes | Drug: Sinapis nigrea semen<br> <br> |
| Placebo Comparator: Thorax wrap with warm water (placebo)<br>Thorax wrap with warm water (placebo), duration: 20 minutes | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in temperature | Temperature (in °Celsius) of feet, lower legs, hands and face measured with a thermographic infrared camera (pre-post-comparison) | max. 40 minutes | 
| Respiratory activity (expiratory CO2 and NO-measurement) | Physiological parameters are measured for pre-post comparison. | max. 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basler Mood Questionnaire (BBS) | filled in by the participants nine times (before and after the thorax wrap and 10 minutes after the intervention) | 40 minutes | 
| Herdecker Wärmeempfindungs-Fragebogen (HeWef) | filled in by the participants nine times (before and after the thorax wrap and 10 minutes after the intervention) | 40 minutes | 
| Warmth perception and skin irritation (NRS) | Warmth perception and skin irritation during the intervention every minute (measured with a numeric rating scale). | 40 minutes | 
| heart rate variability -Parameter (HRV) | Standard Deviation of Normal to Normal (heart rate) (SDNN) | Physiological parameters are measured over a period of 40 minutes | 
| heart rate variability -Parameter (HRV) | Root Mean Square of the Successive Differences (RMSSD) | Physiological parameters are measured over a period of 40 minutes | 
| heart rate variability -Parameter (HRV) | ratio low frequency to high frequency (LF/HF) | Physiological parameters are measured over a period of 40 minutes | 
| heart rate variability -Parameter (HRV) | very low frequency (VLF) | Physiological parameters are measured over a period of 40 minutes | 
| heart rate variability -Parameter (HRV) | NN50 (the number of pairs of successive NNs that differ by more than 50 ms) | Physiological parameters are measured over a period of 40 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physiologcal phenomena, .HRV Parameters, respiratory activity, thorax wraps