Clinical trial NCT02285452: Psychophysiological Effects of Thorax Wraps With Ginger and Mustard Flour
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: physiologcal phenomena
.HRV Parameters
respiratory activity
thorax wraps
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes in temperature
timeFrame: max. 40 minutes
measure: Respiratory activity (expiratory CO2 and NO-measurement)
timeFrame: max. 40 minutes
Secondary outcomes:
measure: Basler Mood Questionnaire (BBS)
timeFrame: 40 minutes
measure: Herdecker Wärmeempfindungs-Fragebogen (HeWef)
timeFrame: 40 minutes
measure: Warmth perception and skin irritation (NRS)
timeFrame: 40 minutes
measure: heart rate variability -Parameter (HRV)
timeFrame: Physiological parameters are measured over a period of 40 minutes
measure: heart rate variability -Parameter (HRV)
timeFrame: Physiological parameters are measured over a period of 40 minutes
measure: heart rate variability -Parameter (HRV)
timeFrame: Physiological parameters are measured over a period of 40 minutes
measure: heart rate variability -Parameter (HRV)
timeFrame: Physiological parameters are measured over a period of 40 minutes
measure: heart rate variability -Parameter (HRV)
timeFrame: Physiological parameters are measured over a period of 40 minutes
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Filderklinik
state: Baden-Württemberg
Study officials:
affiliation: ARCIM-Institute
name: Jan Vagedes, Dr.
role: PRINCIPAL_INVESTIGATOR
References: