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

NCT04271670 | Completed

• 1 other identifier: SWI_03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oncologic Disorders

Keywords

Ginger; Mustard; Footbath; Warmth perception; Infrared thermography; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2

  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

  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

  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

  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

  Immediately before the footbath (t1) and immediately after the footbath (t2)

Study Arms (3)

Warm water footbath with ginger powder

EXPERIMENTAL

Footbath with ginger powder with a maximum duration of 20 minutes.

Other: Ginger powder footbaths

Warm water footbath with mustard powder

EXPERIMENTAL

Footbath with mustard powder with a maximum duration of 20 minutes.

Other: Mustard powder footbaths

Warm water only footbath

ACTIVE COMPARATOR

Warm water only footbath with a maximum duration of 20 minutes.

Other: Warm water only footbaths

Interventions

Ginger powder footbaths OTHER

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)

Warm water footbath with ginger powder

Mustard powder footbaths OTHER

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 footbath with mustard powder

Warm water only footbaths OTHER

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

Warm water only footbath

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Study Officials

• Jan Vagedes, MD

  ARCIM Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: January 15, 2016
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon publication for a duration of three months.
• 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.

Locations

DE (1)