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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warm water footbath with ginger powder | Experimental | Footbath with ginger powder with a maximum duration of 20 minutes. |
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| Warm water footbath with mustard powder | Experimental | Footbath with mustard powder with a maximum duration of 20 minutes. |
|
| Warm water only footbath | Active Comparator | Warm water only footbath with a maximum duration of 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Vagedes, MD | ARCIM Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcim Institute | Filderstadt | Baden-Wurttemberg | 70794 | Germany |
Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
The data will be made available upon publication for a duration of three months.
The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
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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.
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| 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) |
|
| 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) |