Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa

Study Overview
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Brief Summary
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A randomized, controlled, three-arm study to investigate the effects of footbaths with ginger, mustard or warm water alone in female, adolescent patients with Anorexia nervosa and in healthy, female adolescents on psychophysiological parameters.

Detailed Description
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In a cross-over study design, the subjects (21 female patients with Anorexia nervosa, 20 healthy, female controls) receive footbaths with either ginger, mustard or warm water alone in a randomized order with a wash-out period of at least 1-3 days. The effects of each intervention on the objective warmth generation are measured by infrared thermography, whereas the subjective warmth perception is determined by the 'Herdecke warmth perception questionnaire'. All parameters are determined at specified times (t1 = right before, t2 = right after and t3 = 10 minutes following the footbath), which enables an evaluation based on pre-post-comparisons. The statistical analysis comprises analyses of variances based on linear mixed effects models (after checking for carry-over effects).

Official Title
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Efficacy of Footbaths With Ginger, Mustard & Warm Water Only on Psychophysiological Parameters in Female Adolescents With & Without Anorexia Nervosa - a Randomized, Controlled, Three-arm Study With Cross-over Design

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: Warm water
* Other: Mustard
* Other: Ginger


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent of the parents Age 12-18 years Exclusion Criteria: Infectious disease with body temperature above 38 °C Skin damages at the lower legs/feet Known intolerance/ anaphylaxis to mustard or ginger preparations Cardiac arrhythmia Pregnancy Insufficient knowledge of the German language BMI percentile < 10% (for control group)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Warm water<br>12 l footbath with warm water (40 °C) | Other: Warm water<br>* Footbaths were prepared with 12 liters of warm water (40 °C)<br>|
| Experimental: Warm water & Mustard<br>12 l footbath with warm water (40 °C) and 80 g mustard flour | Other: Warm water<br>* Footbaths were prepared with 12 liters of warm water (40 °C)<br>Other: Mustard<br>* 12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)<br>* Other names: Sinapis nigrea semen;|
| Experimental: Warm water & Ginger<br>12 l footbath with warm water (40 °C) and 80 g ginger flour | Other: Warm water<br>* Footbaths were prepared with 12 liters of warm water (40 °C)<br>Other: Ginger<br>* 12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)<br>* Other names: Zingiberis rhizoma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 2-Item Warmth Perception Measure (feet) from t1 to t3 | Self-reported warmth perception at both feet assessed with the Herdecke warmth perception questionnaire right before (t1) and 10 minutes following the footbath (t3). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8. | right before the footbath (t1) and 10 minutes following the footbath (t3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 2-Item Warmth Perception Measure (feet) from t1 to t2 | Self-reported warmth perception at both feet assessed with the Herdecke warmth perception questionnaire right before (t1) and right after the footbath (t2). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8. | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 
| Change in 2-Item Warmth Perception Measure (face) from t1 to t3 | Self-reported warmth perception in the face assessed with the Herdecke warmth perception questionnaire right before (t1) and 10 minutes following the footbath (t3). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8. | right before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in 2-Item Warmth Perception Measure (face) from t1 to t2 | Self-reported warmth perception in the face assessed with the Herdecke warmth perception questionnaire right before (t1) and right after the footbath (t2). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8. | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 
| Change in 2-Item Warmth Perception Measure (hands) from t1 to t3 | Self-reported warmth perception at both hands assessed with the Herdecke warmth perception questionnaire right before (t1) and 10 minutes following the footbath (t3). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8. | right before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in 2-Item Warmth Perception Measure (hands) from t1 to t2 | Self-reported warmth perception at both hands assessed with the Herdecke warmth perception questionnaire right before (t1) and right after the footbath (t2). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8. | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 
| Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3 | Self-reported overall warmth perception assessed with the Herdecke warmth perception questionnaire right before (t1) and 10 minutes following the footbath (t3). The item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 4. | right before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2 | Self-reported overall warmth perception assessed with the Herdecke warmth perception questionnaire right before (t1) and right after the footbath (t2). The item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 4. | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 
| Change in Distal Skin Temperature Measure (feet) from t1 to t3 | Distal skin temperature in °C at both feet measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and 10 minutes following the footbath (t3). | right before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in Distal Skin Temperature Measure (feet) from t1 to t2 | Distal skin temperature in °C at both feet measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and right after the footbath (t2). | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 
| Change in Distal Skin Temperature Measure (face) from t1 to t3 | Distal skin temperature in °C in the face measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and 10 minutes following the footbath (t3). | right before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in Distal Skin Temperature Measure (face) from t1 to t2 | Distal skin temperature in °C in the face measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and right after the footbath (t2). | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 
| Change in Distal Skin Temperature Measure (hands) from t1 to t3 | Distal skin temperature in °C at both hands measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and 10 minutes following the footbath (t3). | right before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in Distal Skin Temperature Measure (hands) from t1 to t2 | Distal skin temperature in °C at both hands measured with a high-definition infrared camera (FLIR-Systems, type SC660) right before (t1) and right after the footbath (t2). | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) |