Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Warm water footbath with ginger powder
Footbath with ginger powder with a maximum duration of 20 minutes.
干预措施: Ginger powder footbaths (Other)
Warm water footbath with mustard powder
Footbath with mustard powder with a maximum duration of 20 minutes.
干预措施: Mustard powder footbaths (Other)
Warm water only footbath
Warm water only footbath with a maximum duration of 20 minutes.
干预措施: Warm water only footbaths (Other)
结局指标
主要结局
Change in subjective feeling of warmth at the feet as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t3
时间窗: Immediately before the footbath (t1) and 10 minutes following the footbath (t3)
Self-reported feeling of warmth at the feet, measured with the "Herdecke Warmth Perception Questionnaire", score between 0=cold and 4=hot
次要结局
- 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 overall warmth as assessed by the "Herdecke Warmth Perception Questionnaire" from t1 to t2(Immediately before the footbath (t1) and immediately after the footbath (t2))
- Warmth perception and skin stimulus at the feet during the footbath(Up to 20 minutes)
- 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 overall warmth 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 well-being from t1 to t3(Immediately before (t1) and ten minutes following the footbath (t3))
- Change in skin temperature in the face 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 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))
- Change in well-being from t1 to t2(Immediately before (t1) and immediately after the footbath (t2))
- Change in skin temperature at the feet from t1 to t3(Immediately before (t1) and ten minutes following the footbath (t3))
- Change in skin temperature at the feet from t1 to t2(Immediately before the footbath (t1) and immediately after the footbath (t2))
- Change in skin temperature at the hands from t1 to t2(Immediately before the footbath (t1) and immediately after the footbath (t2))
- Change in skin temperature in the face from t1 to t3(Immediately before (t1) and ten minutes following the footbath (t3))
- Change in skin temperature at the hands from t1 to t3(Immediately before (t1) and ten minutes following the footbath (t3))