Clinical trial NCT04271670: Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncologic Disorders
Keywords: Ginger
Mustard
Footbath
Warmth perception
Infrared thermography
Healthy volunteers
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3
timeFrame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)
Secondary outcomes:
measure: Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2
timeFrame: Immediately before the footbath (t1) and immediately after the footbath (t2)
measure: Change in subjective feeling of warmth in the face as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3
timeFrame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in subjective feeling of warmth in the face as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2
timeFrame: Immediately before the footbath (t1) and immediately after the footbath (t2)
measure: Change in subjective feeling of warmth at the hands as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3
timeFrame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in subjective feeling of warmth at the hands as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2
timeFrame: Immediately before the footbath (t1) and immediately after the footbath (t2)
measure: Change in subjective feeling of overall warmth as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3
timeFrame: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)
measure: Change in subjective feeling of overall warmth as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2
timeFrame: Immediately before the footbath (t1) and immediately after the footbath (t2)
measure: Warmth perception and skin stimulus at the feet during the footbath
timeFrame: Up to 20 minutes
measure: Change in well-being from t1 to t2
timeFrame: Immediately before (t1) and immediately after the footbath (t2)
measure: Change in well-being from t1 to t3
timeFrame: Immediately before (t1) and ten minutes following the footbath (t3)
measure: Change in skin temperature at the feet from t1 to t3
timeFrame: Immediately before (t1) and ten minutes following the footbath (t3)
measure: Change in skin temperature at the feet from t1 to t2
timeFrame: Immediately before the footbath (t1) and immediately after the footbath (t2)
measure: Change in skin temperature at the hands from t1 to t3
timeFrame: Immediately before (t1) and ten minutes following the footbath (t3)
measure: Change in skin temperature at the hands from t1 to t2
timeFrame: Immediately before the footbath (t1) and immediately after the footbath (t2)
measure: Change in skin temperature in the face from t1 to t3
timeFrame: Immediately before (t1) and ten minutes following the footbath (t3)
measure: Change in skin temperature in the face from t1 to t2
timeFrame: Immediately before the footbath (t1) and immediately after the footbath (t2)
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute
name: Jan Vagedes, MD
role: STUDY_DIRECTOR
References: