Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease
- Conditions
- Oncologic Disorders
- Interventions
- Other: Warm water only footbathsOther: Ginger powder footbathsOther: Mustard powder footbaths
- Registration Number
- NCT04271670
- Lead Sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Warm water only footbath Warm water only footbaths Warm water only footbath with a maximum duration of 20 minutes. Warm water footbath with ginger powder Ginger powder footbaths Footbath with ginger powder with a maximum duration of 20 minutes. Warm water footbath with mustard powder Mustard powder footbaths Footbath with mustard powder with a maximum duration of 20 minutes.
- Primary Outcome Measures
Name Time Method Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3 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 Outcome Measures
Name Time Method Change in subjective feeling of warmth in the face as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2 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
Change in subjective feeling of warmth at the hands as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3 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
Change in subjective feeling of overall warmth as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2 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
Warmth perception and skin stimulus at the feet during the footbath 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)
Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2 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
Change in subjective feeling of overall warmth as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3 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
Change in well-being from t1 to t3 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)
Change in skin temperature in the face from t1 to t2 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)
Change in subjective feeling of warmth in the face as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3 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
Change in subjective feeling of warmth at the hands as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2 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
Change in well-being from t1 to t2 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
Change in skin temperature at the feet from t1 to t3 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)
Change in skin temperature at the feet from t1 to t2 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)
Change in skin temperature at the hands from t1 to t2 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)
Change in skin temperature in the face from t1 to t3 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)
Change in skin temperature at the hands from t1 to t3 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)
Trial Locations
- Locations (1)
Arcim Institute
🇩🇪Filderstadt, Baden-Württemberg, Germany