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

ARCIM Institute Academic Research in Complementary and Integrative Medicine36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Oncologic Disorders

Interventions

Ginger powder footbathsOTHER

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 footbathsOTHER

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 footbathsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

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