Oncologic DisordersNCT04271670
Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease
A study testing Ginger powder footbaths, Mustard powder footbaths and Warm water only footbaths in people with Oncologic Disorders, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oncologic Disorders
- What is being tested?
- Ginger powder footbaths, Mustard powder footbaths and Warm water only footbaths
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2016to 18 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Oncologic Disorders
- Being tested
- Ginger powder footbaths, Mustard powder footbaths, Warm water only footbaths
- Keywords
- Ginger, Mustard, Footbath, Warmth perception, Infrared thermography, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Warm water footbath with ginger powder | Experimental | Footbath with ginger powder with a maximum duration of 20 minutes. Receives: Other: Ginger powder footbaths |
| Warm water footbath with mustard powder | Experimental | Footbath with mustard powder with a maximum duration of 20 minutes. Receives: Other: Mustard powder footbaths |
| Warm water only footbath | Active comparator | Warm water only footbath with a maximum duration of 20 minutes. Receives: Other: Warm water only footbaths |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Immediately before the footbath (t1) and immediately after the footbath (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Jan 2016
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, MD, Study director, ARCIM Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271670
- Sponsor's protocol ID
- SWI_03
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04271670
- Acronym / sponsor ID
- SWI_03
- Conditions
- Oncologic Disorders
- Keywords
- Ginger, Mustard, Footbath, Warmth perception, Infrared thermography, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Warm water footbath with ginger powder | Experimental | Other: Ginger powder footbathsFootbath with ginger powder with a maximum duration of 20 minutes. |
| Warm water footbath with mustard powder | Experimental | Other: Mustard powder footbathsFootbath with mustard powder with a maximum duration of 20 minutes. |
| Warm water only footbath | Active comparator | Other: Warm water only footbathsWarm water only footbath with a maximum duration of 20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger powder footbaths20-minute footbath with 12 liters of 40°C warm water and an additive of 80g dried ginger powder (reaching up to mid-calf level) | Other | Warm water footbath with ginger powder |
| Mustard powder footbaths20-minute footbath with 12 liters of 40° C warm water and an additive of 80g dried mustard powder (reaching up to mid-calf level) | Other | Warm water footbath with mustard powder |
| Warm water only footbaths20-minute footbath with 12 liters of 40° C warm water without any additive (reaching up to mid-calf level) | Other | Warm water only footbath |
Primary outcome
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
16 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Warmth perception and skin stimulus at the feet during the footbath
Time frame: Up to 20 minutes
Change in well-being from t1 to t2
Time frame: 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)
Change in skin temperature at the feet from t1 to t3
Time frame: 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)
Change in skin temperature at the hands from t1 to t3
Time frame: 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)
Change in skin temperature in the face from t1 to t3
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, MD study director
ARCIM Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger powder footbaths, Mustard powder footbaths and Warm water only footbaths in people with Oncologic Disorders, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.