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

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

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.

Study Overview

• Status: Completed
• Conditions: Oncologic Disorders
• Intervention / Treatment: Other: Ginger powder footbaths; Other: Mustard powder footbaths; Other: Warm water only footbaths

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): September 18, 2017

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Healthy volunteers; Infrared thermography; Ginger; Mustard; Footbath; Warmth perception
• Other Study ID Numbers: SWI_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
• IPD Sharing Time Frame: The data will be made available upon publication for a duration of three months.
• IPD Sharing Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No