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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Warm water
Mustard
Ginger
Sponsored by
ARCIM Institute Academic Research in Complementary and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Filderklinik

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Warm water

Warm water & Mustard

Warm water & Ginger

Arm Description

12 l footbath with warm water (40 °C)

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).

Full Information

First Posted
January 12, 2018
Last Updated
May 8, 2018
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03519698
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
June 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warm water
Arm Type
Placebo Comparator
Arm Description
12 l footbath with warm water (40 °C)
Arm Title
Warm water & Mustard
Arm Type
Experimental
Arm Description
12 l footbath with warm water (40 °C) and 80 g mustard flour
Arm Title
Warm water & Ginger
Arm Type
Experimental
Arm Description
12 l footbath with warm water (40 °C) and 80 g ginger flour
Intervention Type
Other
Intervention Name(s)
Warm water
Intervention Description
Footbaths were prepared with 12 liters of warm water (40 °C)
Intervention Type
Other
Intervention Name(s)
Mustard
Other Intervention Name(s)
Sinapis nigrea semen
Intervention Description
12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)
Intervention Type
Other
Intervention Name(s)
Ginger
Other Intervention Name(s)
Zingiberis rhizoma
Intervention Description
12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)
Primary Outcome Measure Information:
Title
Change in 2-Item Warmth Perception Measure (feet) from t1 to t3
Description
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.
Time Frame
right before the footbath (t1) and 10 minutes following the footbath (t3)
Secondary Outcome Measure Information:
Title
Change in 2-Item Warmth Perception Measure (feet) from t1 to t2
Description
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.
Time Frame
right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Title
Change in 2-Item Warmth Perception Measure (face) from t1 to t3
Description
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.
Time Frame
right before the footbath (t1) and 10 minutes following the footbath (t3)
Title
Change in 2-Item Warmth Perception Measure (face) from t1 to t2
Description
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.
Time Frame
right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Title
Change in 2-Item Warmth Perception Measure (hands) from t1 to t3
Description
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.
Time Frame
right before the footbath (t1) and 10 minutes following the footbath (t3)
Title
Change in 2-Item Warmth Perception Measure (hands) from t1 to t2
Description
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.
Time Frame
right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Title
Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3
Description
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.
Time Frame
right before the footbath (t1) and 10 minutes following the footbath (t3)
Title
Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2
Description
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.
Time Frame
right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Title
Change in Distal Skin Temperature Measure (feet) from t1 to t3
Description
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).
Time Frame
right before the footbath (t1) and 10 minutes following the footbath (t3)
Title
Change in Distal Skin Temperature Measure (feet) from t1 to t2
Description
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).
Time Frame
right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Title
Change in Distal Skin Temperature Measure (face) from t1 to t3
Description
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).
Time Frame
right before the footbath (t1) and 10 minutes following the footbath (t3)
Title
Change in Distal Skin Temperature Measure (face) from t1 to t2
Description
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).
Time Frame
right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)
Title
Change in Distal Skin Temperature Measure (hands) from t1 to t3
Description
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).
Time Frame
right before the footbath (t1) and 10 minutes following the footbath (t3)
Title
Change in Distal Skin Temperature Measure (hands) from t1 to t2
Description
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).
Time Frame
right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Vagedes, Dr.
Organizational Affiliation
ARCIM Institute; University of Tuebingen
Official's Role
Study Director
Facility Information:
Facility Name
Filderklinik
City
Filderstadt
State/Province
Baden-Württemberg
ZIP/Postal Code
70794
Country
Germany

12. IPD Sharing Statement

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

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