Efficacy of Footbaths With Ginger, Mustard & Warm Water Only on Psychophysiological Parameters in Female Adolescents With & Without Anorexia Nervosa - a Randomized, Controlled, Three-arm Study With Cross-over Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in 2-Item Warmth Perception Measure (feet) from t1 to t3
研究概览
简要总结
A randomized, controlled, three-arm study to investigate the effects of footbaths with ginger, mustard or warm water alone in female, adolescent patients with Anorexia nervosa and in healthy, female adolescents on psychophysiological parameters.
详细描述
In a cross-over study design, the subjects (21 female patients with Anorexia nervosa, 20 healthy, female controls) receive footbaths with either ginger, mustard or warm water alone in a randomized order with a wash-out period of at least 1-3 days. The effects of each intervention on the objective warmth generation are measured by infrared thermography, whereas the subjective warmth perception is determined by the 'Herdecke warmth perception questionnaire'. All parameters are determined at specified times (t1 = right before, t2 = right after and t3 = 10 minutes following the footbath), which enables an evaluation based on pre-post-comparisons. The statistical analysis comprises analyses of variances based on linear mixed effects models (after checking for carry-over effects).
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent of the parents
- •Age 12-18 years
排除标准
- •Infectious disease with body temperature above 38 °C
- •Skin damages at the lower legs/feet
- •Known intolerance/ anaphylaxis to mustard or ginger preparations
- •Cardiac arrhythmia
- •Pregnancy
- •Insufficient knowledge of the German language
- •BMI percentile < 10% (for control group)
研究组 & 干预措施
Warm water
12 l footbath with warm water (40 °C)
干预措施: Warm water (Other)
Warm water & Mustard
12 l footbath with warm water (40 °C) and 80 g mustard flour
干预措施: Warm water (Other)
Warm water & Mustard
12 l footbath with warm water (40 °C) and 80 g mustard flour
干预措施: Mustard (Other)
Warm water & Ginger
12 l footbath with warm water (40 °C) and 80 g ginger flour
干预措施: Warm water (Other)
Warm water & Ginger
12 l footbath with warm water (40 °C) and 80 g ginger flour
干预措施: Ginger (Other)
结局指标
主要结局
Change in 2-Item Warmth Perception Measure (feet) from t1 to t3
时间窗: right before the footbath (t1) and 10 minutes following the footbath (t3)
Self-reported warmth perception at both feet assessed with the "Herdecke warmth perception questionnaire" right before (t1) and 10 minutes following the footbath (t3). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a total between 0 - 8.
次要结局
- Change in 2-Item Warmth Perception Measure (feet) from t1 to t2(right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length))
- Change in 2-Item Warmth Perception Measure (face) from t1 to t3(right before the footbath (t1) and 10 minutes following the footbath (t3))
- Change in 2-Item Warmth Perception Measure (face) from t1 to t2(right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length))
- Change in 2-Item Warmth Perception Measure (hands) from t1 to t3(right before the footbath (t1) and 10 minutes following the footbath (t3))
- Change in 2-Item Warmth Perception Measure (hands) from t1 to t2(right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length))
- Change in Distal Skin Temperature Measure (face) from t1 to t2(right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length))
- Change in Distal Skin Temperature Measure (hands) from t1 to t3(right before the footbath (t1) and 10 minutes following the footbath (t3))
- Change in Distal Skin Temperature Measure (hands) from t1 to t2(right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length))
- Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3(right before the footbath (t1) and 10 minutes following the footbath (t3))
- Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2(right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length))
- Change in Distal Skin Temperature Measure (feet) from t1 to t3(right before the footbath (t1) and 10 minutes following the footbath (t3))
- Change in Distal Skin Temperature Measure (feet) from t1 to t2(right before the footbath (t1) and right after the footbath (t2, 5-20 minutes after t1 depending on the actual footbath length))
- Change in Distal Skin Temperature Measure (face) from t1 to t3(right before the footbath (t1) and 10 minutes following the footbath (t3))
研究者
Dr. Jan Vagedes
Director, Clinical Research
ARCIM Institute Academic Research in Complementary and Integrative Medicine