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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2017-06-22

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.

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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).

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Warm water

12 l footbath with warm water (40 °C)

Group Type PLACEBO_COMPARATOR

Warm water

Intervention Type OTHER

Footbaths were prepared with 12 liters of warm water (40 °C)

Warm water & Mustard

12 l footbath with warm water (40 °C) and 80 g mustard flour

Group Type EXPERIMENTAL

Warm water

Intervention Type OTHER

Footbaths were prepared with 12 liters of warm water (40 °C)

Mustard

Intervention Type OTHER

12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)

Warm water & Ginger

12 l footbath with warm water (40 °C) and 80 g ginger flour

Group Type EXPERIMENTAL

Warm water

Intervention Type OTHER

Footbaths were prepared with 12 liters of warm water (40 °C)

Ginger

Intervention Type OTHER

12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)

Interventions

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Warm water

Footbaths were prepared with 12 liters of warm water (40 °C)

Intervention Type OTHER

Mustard

12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)

Intervention Type OTHER

Ginger

12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)

Intervention Type OTHER

Other Intervention Names

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Sinapis nigrea semen Zingiberis rhizoma

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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes