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Completed

NCT Number: NCT03519698

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

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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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Warm water

Other

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

Mustard

Other

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

Other names: Sinapis nigrea semen

Ginger

Other

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

Other names: Zingiberis rhizoma

Primary outcomes

  1. Change in 2-Item Warmth Perception Measure (feet) from t1 to t3

    Time frame: right before the footbath (t1) and 10 minutes following the footbath (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 outcomes

  1. Change in 2-Item Warmth Perception Measure (feet) from t1 to 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)

    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.

  2. Change in 2-Item Warmth Perception Measure (face) from t1 to t3

    Time frame: right before the footbath (t1) and 10 minutes following the footbath (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.

  3. Change in 2-Item Warmth Perception Measure (face) from t1 to 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)

    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.

  4. Change in 2-Item Warmth Perception Measure (hands) from t1 to t3

    Time frame: right before the footbath (t1) and 10 minutes following the footbath (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.

  5. Change in 2-Item Warmth Perception Measure (hands) from t1 to 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)

    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.

  6. Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3

    Time frame: right before the footbath (t1) and 10 minutes following the footbath (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.

  7. Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to 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)

    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.

  8. Change in Distal Skin Temperature Measure (feet) from t1 to t3

    Time frame: right before the footbath (t1) and 10 minutes following the footbath (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).

  9. Change in Distal Skin Temperature Measure (feet) from t1 to 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)

    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).

  10. Change in Distal Skin Temperature Measure (face) from t1 to t3

    Time frame: right before the footbath (t1) and 10 minutes following the footbath (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).

  11. Change in Distal Skin Temperature Measure (face) from t1 to 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)

    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).

  12. Change in Distal Skin Temperature Measure (hands) from t1 to t3

    Time frame: right before the footbath (t1) and 10 minutes following the footbath (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).

  13. Change in Distal Skin Temperature Measure (hands) from t1 to 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)

    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).

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 9, 2018
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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