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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warm water | Placebo Comparator | 12 l footbath with warm water (40 °C) |
|
| Warm water & Mustard | Experimental | 12 l footbath with warm water (40 °C) and 80 g mustard flour |
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| Warm water & Ginger | Experimental | 12 l footbath with warm water (40 °C) and 80 g ginger flour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warm water | Other | Footbaths were prepared with 12 liters of warm water (40 °C) |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Vagedes, Dr. | ARCIM Institute; University of Tuebingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Filderklinik | Filderstadt | Baden-Wurttemberg | 70794 | Germany |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000588 | Amines |
| C000713927 | ginger extract |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
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| Mustard | Other | 12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.) |
|
|
| Ginger | Other | 12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.) |
|
|
| 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) |