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Completed

NCT Number: NCT04271670

Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease

A randomized, controlled, three-arm trial to investigate the effects of warm water footbaths with and without the addition of ginger or mustard powder on psychosocial parameters in patients with an oncological disease and in healthy controls.

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Key information

Conditions

Oncologic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

A randomized, controlled trial with cross-over design in which the subjects (23 patients with an oncological disease, 13 healthy controls) receive warm water footbaths with added ginger (experimental) or mustard powder (experimental) or without additives (active comparator). The wash-out period between two consecutive footbath interventions is at least one day. Outcome measures are assessed right before (t1), right after (t2) and 10 minutes following the footbath (t3). The main focus is on the change in subjective perception of warmth distribution between t1 and t3. Moreover, the objective skin temperature distribution and psychosocial scores are assessed. The primary outcome measure is analyzed with a linear mixed effects model (after checking for carry-over effects). Secondary outcome measures are described descriptively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent
  • Age between 18 and 65 years
  • Oncological disorder with at least one chemotherapy or radiation in the treatment history
  • Current inpatient treatment in the oncology ward of the Filderklinik (Filderstadt, Germany) with a minimum stay of 4 days

Exclusion criteria

  • Infectious disease (with more than 38 °C core body temperature)
  • Skin lesion on the lower legs or feet
  • Hypersensitivity to mustard or ginger products
  • Cardiac arrhythmia
  • Pregnancy
  • Insufficient knowledge of the German language
  • Bedriddenness
  • Poor general condition (according to the assessment of the attending physicians)

Treatment and study plan

Ginger powder footbaths

Other

20-minute footbath with 12 liters of 40°C warm water and an additive of 80g dried ginger powder (reaching up to mid-calf level)

Mustard powder footbaths

Other

20-minute footbath with 12 liters of 40° C warm water and an additive of 80g dried mustard powder (reaching up to mid-calf level)

Warm water only footbaths

Other

20-minute footbath with 12 liters of 40° C warm water without any additive (reaching up to mid-calf level)

Primary outcomes

  1. Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3

    Time frame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)

    Self-reported feeling of warmth at the feet, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

Secondary outcomes

  1. Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2

    Time frame: Immediately before the footbath (t1) and immediately after the footbath (t2)

    Self-reported feeling of warmth at the feet, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

  2. Change in subjective feeling of warmth in the face as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3

    Time frame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)

    Self-reported feeling of warmth in the face, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

  3. Change in subjective feeling of warmth in the face as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2

    Time frame: Immediately before the footbath (t1) and immediately after the footbath (t2)

    Self-reported feeling of warmth in the face, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

  4. Change in subjective feeling of warmth at the hands as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3

    Time frame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)

    Self-reported feeling of warmth at the hands, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

  5. Change in subjective feeling of warmth at the hands as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2

    Time frame: Immediately before the footbath (t1) and immediately after the footbath (t2)

    Self-reported feeling of warmth at the hands, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

  6. Change in subjective feeling of overall warmth as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3

    Time frame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)

    Self-reported feeling of overall warmth, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

  7. Change in subjective feeling of overall warmth as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2

    Time frame: Immediately before the footbath (t1) and immediately after the footbath (t2)

    Self-reported feeling of overall warmth, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot

  8. Warmth perception and skin stimulus at the feet during the footbath

    Time frame: Up to 20 minutes

    Self-reported perception of warmth and skin stimulus during the footbath, assessed with a dynamic warmth and skin stimulus visual analog scale (VAS), applied once per minute (0 = cold/no stimulus; 10 = very hot/very strong stimulus)

  9. Change in well-being from t1 to t2

    Time frame: Immediately before (t1) and immediately after the footbath (t2)

    Self-reported well-being, assessed with the "Basler Befindlichkeits-Skala" (Basel Mood Questionnaire, BBS; 16 items; 7-point rating scale; higher values

  10. Change in well-being from t1 to t3

    Time frame: Immediately before (t1) and ten minutes following the footbath (t3)

    Self-reported well-being, assessed with the "Basler Befindlichkeits-Skala" (Basel Mood Questionnaire, BBS; 16 items; 7-point rating scale; higher values represent a better outcome)

  11. Change in skin temperature at the feet from t1 to t3

    Time frame: Immediately before (t1) and ten minutes following the footbath (t3)

    Skin temperature (in °C) at both feet, measured with a high-definition infrared camera (FLIR-Systems, type SC660)

  12. Change in skin temperature at the feet from t1 to t2

    Time frame: Immediately before the footbath (t1) and immediately after the footbath (t2)

    Skin temperature (in °C) at both feet, measured with a high-definition infrared camera (FLIR-Systems, type SC660)

  13. Change in skin temperature at the hands from t1 to t3

    Time frame: Immediately before (t1) and ten minutes following the footbath (t3)

    Skin temperature (in °C) at both hands, measured with a high-definition infrared camera (FLIR-Systems, type SC660)

  14. Change in skin temperature at the hands from t1 to t2

    Time frame: Immediately before the footbath (t1) and immediately after the footbath (t2)

    Skin temperature (in °C) at both hands, measured with a high-definition infrared camera (FLIR-Systems, type SC660)

  15. Change in skin temperature in the face from t1 to t3

    Time frame: Immediately before (t1) and ten minutes following the footbath (t3)

    Skin temperature (in °C) in the face, measured with a high-definition infrared camera (FLIR-Systems, type SC660)

  16. Change in skin temperature in the face from t1 to t2

    Time frame: Immediately before the footbath (t1) and immediately after the footbath (t2)

    Skin temperature (in °C) in the face, measured with a high-definition infrared camera (FLIR-Systems, type SC660)

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study title

Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

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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