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

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

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Warm water; Other: Mustard; Other: Ginger

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).

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Filderklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Investigators: Study Director: Jan Vagedes, Dr., ARCIM Institute; University of Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2015
• Primary Completion (Actual): June 22, 2017
• Study Completion (Actual): June 22, 2017

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: SWI_05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No