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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oncologic Disorders

Intervention / Treatment
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* Other: Ginger powder footbaths
* Other: Mustard powder footbaths
* Other: Warm water only footbaths


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant receives all three footbath interventions (warm water only=WA, with added ginger powder=GI, with added mustard powder=MU) in a randomized order stratified by gender. For this, participants are randomly allocated to one of six possible footbath sequences (a: MU-WA-GI, b: MU-GI-WA, c: WA-GI-MU, d: WA-MU-GI, e: GI-MU-WA, f: GI-WA-MU). For the main analysis, groups are pooled together with regard to the intervention received (WA vs. MU vs. GI) after checking for potential carry-over effects.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm water footbath with ginger powder<br>Footbath with ginger powder with a maximum duration of 20 minutes. | Other: Ginger powder footbaths<br>* 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)<br>|
| Experimental: Warm water footbath with mustard powder<br>Footbath with mustard powder with a maximum duration of 20 minutes. | Other: Mustard powder footbaths<br>* 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)<br>|
| Active Comparator: Warm water only footbath<br>Warm water only footbath with a maximum duration of 20 minutes. | Other: Warm water only footbaths<br>* 20-minute footbath with 12 liters of 40° C warm water without any additive (reaching up to mid-calf level)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective feeling of warmth at the feet as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t3 | Self-reported feeling of warmth at the feet, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and 10 minutes following the footbath (t3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective feeling of warmth at the feet as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t2 | Self-reported feeling of warmth at the feet, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and immediately after the footbath (t2) | 
| Change in subjective feeling of warmth in the face as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t3 | Self-reported feeling of warmth in the face, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in subjective feeling of warmth in the face as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t2 | Self-reported feeling of warmth in the face, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and immediately after the footbath (t2) | 
| Change in subjective feeling of warmth at the hands as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t3 | Self-reported feeling of warmth at the hands, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in subjective feeling of warmth at the hands as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t2 | Self-reported feeling of warmth at the hands, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and immediately after the footbath (t2) | 
| Change in subjective feeling of overall warmth as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t3 | Self-reported feeling of overall warmth, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and 10 minutes following the footbath (t3) | 
| Change in subjective feeling of overall warmth as assessed by the Herdecke Warmth Perception Questionnaire from t1 to t2 | Self-reported feeling of overall warmth, measured with the Herdecke Warmth Perception Questionnaire, score between 0=cold and 4=hot | Immediately before the footbath (t1) and immediately after the footbath (t2) | 
| Warmth perception and skin stimulus at the feet during the footbath | 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) | Up to 20 minutes | 
| Change in well-being from t1 to t2 | Self-reported well-being, assessed with the Basler Befindlichkeits-Skala (Basel Mood Questionnaire, BBS; 16 items; 7-point rating scale; higher values | Immediately before (t1) and immediately after the footbath (t2) | 
| Change in well-being from t1 to 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) | Immediately before (t1) and ten minutes following the footbath (t3) | 
| Change in skin temperature at the feet from t1 to t3 | Skin temperature (in °C) at both feet, measured with a high-definition infrared camera (FLIR-Systems, type SC660) | Immediately before (t1) and ten minutes following the footbath (t3) | 
| Change in skin temperature at the feet from t1 to t2 | Skin temperature (in °C) at both feet, measured with a high-definition infrared camera (FLIR-Systems, type SC660) | Immediately before the footbath (t1) and immediately after the footbath (t2) | 
| Change in skin temperature at the hands from t1 to t3 | Skin temperature (in °C) at both hands, measured with a high-definition infrared camera (FLIR-Systems, type SC660) | Immediately before (t1) and ten minutes following the footbath (t3) | 
| Change in skin temperature at the hands from t1 to t2 | Skin temperature (in °C) at both hands, measured with a high-definition infrared camera (FLIR-Systems, type SC660) | Immediately before the footbath (t1) and immediately after the footbath (t2) | 
| Change in skin temperature in the face from t1 to t3 | Skin temperature (in °C) in the face, measured with a high-definition infrared camera (FLIR-Systems, type SC660) | Immediately before (t1) and ten minutes following the footbath (t3) | 
| Change in skin temperature in the face from t1 to t2 | Skin temperature (in °C) in the face, measured with a high-definition infrared camera (FLIR-Systems, type SC660) | Immediately before the footbath (t1) and immediately after the footbath (t2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginger, Mustard, Footbath, Warmth perception, Infrared thermography, Healthy volunteers