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

Oncologic Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271670
• Other study ID #: SWI_03
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: September 18, 2017

Study information

• Verified date: February 2020
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 18, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Oncologic Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	Arcim Institute	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)