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

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status: Completed

Conditions: Oncologic Disorders

Treatments: Other: Mustard powder footbaths; Other: Warm water only footbaths; Other: Ginger powder footbaths

Study type: Interventional

Funder types: Other

Identifiers

NCT04271670

SWI_03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Warm water footbath with ginger powder

Experimental group

Description:

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

Treatment:

Other: Ginger powder footbaths

Warm water footbath with mustard powder

Experimental group

Description:

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

Treatment:

Other: Mustard powder footbaths

Warm water only footbath

Active Comparator group

Description:

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

Treatment:

Other: Warm water only footbaths