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

February 13, 2020 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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
Immediately before the footbath (t1) and 10 minutes following the footbath (t3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
Immediately before the footbath (t1) and immediately after the footbath (t2)
Warmth perception and skin stimulus at the feet during the footbath
Time Frame: 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)
Up to 20 minutes
Change in well-being from t1 to t2
Time Frame: 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
Immediately before (t1) and immediately after the footbath (t2)
Change in well-being from t1 to t3
Time Frame: 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)
Immediately before (t1) and ten minutes following the footbath (t3)
Change in skin temperature at the feet from t1 to t3
Time Frame: 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)
Immediately before (t1) and ten minutes following the footbath (t3)
Change in skin temperature at the feet from t1 to t2
Time Frame: 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)
Immediately before the footbath (t1) and immediately after the footbath (t2)
Change in skin temperature at the hands from t1 to t3
Time Frame: 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)
Immediately before (t1) and ten minutes following the footbath (t3)
Change in skin temperature at the hands from t1 to t2
Time Frame: 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)
Immediately before the footbath (t1) and immediately after the footbath (t2)
Change in skin temperature in the face from t1 to t3
Time Frame: 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)
Immediately before (t1) and ten minutes following the footbath (t3)
Change in skin temperature in the face from t1 to t2
Time Frame: 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)
Immediately before the footbath (t1) and immediately after the footbath (t2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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