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

Anorexia Nervosa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519698
• Other study ID #: SWI_05
• Status: Completed
• Phase: N/A
• Start date: December 15, 2015
• Est. completion date: June 22, 2017

Study information

• Verified date: May 2018
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Warm water
Footbaths were prepared with 12 liters of warm water (40 °C)
• Mustard
12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)
• Ginger
12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)

Locations

Country	Name	City	State
Germany	Filderklinik	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)