Clinical trial NCT03519698: Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 41
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in 2-Item Warmth Perception Measure (feet) from t1 to t3
timeFrame: right before the footbath (t1) and 10 minutes following the footbath (t3)
Secondary outcomes:
measure: Change in 2-Item Warmth Perception Measure (feet) from t1 to t2
timeFrame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
measure: Change in 2-Item Warmth Perception Measure (face) from t1 to t3
timeFrame: right before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in 2-Item Warmth Perception Measure (face) from t1 to t2
timeFrame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
measure: Change in 2-Item Warmth Perception Measure (hands) from t1 to t3
timeFrame: right before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in 2-Item Warmth Perception Measure (hands) from t1 to t2
timeFrame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
measure: Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3
timeFrame: right before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2
timeFrame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
measure: Change in Distal Skin Temperature Measure (feet) from t1 to t3
timeFrame: right before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in Distal Skin Temperature Measure (feet) from t1 to t2
timeFrame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
measure: Change in Distal Skin Temperature Measure (face) from t1 to t3
timeFrame: right before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in Distal Skin Temperature Measure (face) from t1 to t2
timeFrame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
measure: Change in Distal Skin Temperature Measure (hands) from t1 to t3
timeFrame: right before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in Distal Skin Temperature Measure (hands) from t1 to t2
timeFrame: right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Filderklinik
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute; University of Tuebingen
name: Jan Vagedes, Dr.
role: STUDY_DIRECTOR
References: