Anorexia Nervosa
Conditions
Brief summary
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
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).
Interventions
OTHERWarm water
Footbaths were prepared with 12 liters of warm water (40 °C)
OTHERMustard
12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)
OTHERGinger
12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)
Sponsors
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 18 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 2-Item Warmth Perception Measure (feet) from t1 to t3 | right before the footbath (t1) and 10 minutes following the footbath (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 2-Item Warmth Perception Measure (face) from t1 to t3 | right before the footbath (t1) and 10 minutes following the footbath (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. |
| Change in 2-Item Warmth Perception Measure (face) from t1 to t2 | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 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. |
| Change in 2-Item Warmth Perception Measure (hands) from t1 to t3 | right before the footbath (t1) and 10 minutes following the footbath (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. |
| Change in 2-Item Warmth Perception Measure (hands) from t1 to t2 | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 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. |
| Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3 | right before the footbath (t1) and 10 minutes following the footbath (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. |
| Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2 | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 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. |
| Change in 2-Item Warmth Perception Measure (feet) from t1 to t2 | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 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. |
| Change in Distal Skin Temperature Measure (feet) from t1 to t2 | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 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). |
| Change in Distal Skin Temperature Measure (face) from t1 to t3 | right before the footbath (t1) and 10 minutes following the footbath (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). |
| Change in Distal Skin Temperature Measure (face) from t1 to t2 | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 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). |
| Change in Distal Skin Temperature Measure (hands) from t1 to t3 | right before the footbath (t1) and 10 minutes following the footbath (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). |
| Change in Distal Skin Temperature Measure (hands) from t1 to t2 | right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length) | 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). |
| Change in Distal Skin Temperature Measure (feet) from t1 to t3 | right before the footbath (t1) and 10 minutes following the footbath (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). |
Countries
Germany
Outcome results
None listed