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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-15

Study Completion Date

2017-09-18

Brief Summary

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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.

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Detailed Description

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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

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Oncologic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Warm water footbath with ginger powder

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

Group Type EXPERIMENTAL

Ginger powder footbaths

Intervention Type 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 mustard powder

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

Group Type EXPERIMENTAL

Mustard powder footbaths

Intervention Type 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 only footbath

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

Group Type ACTIVE_COMPARATOR

Warm water only footbaths

Intervention Type OTHER

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

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes