NCT03886207已完成不适用
Efficacy of Foot Baths With and Without Ginger Powder Additive on the Subjective Feeling of Warmth and on Body Core Temperature of Adolescents With Anorexia Nervosa - a Randomized, Controlled Pilot Study
ARCIM Institute Academic Research in Complementary and Integrative Medicine1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年4月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Chnge in Subjective feeling of overall warmth
研究概览
简要总结
A study to explore whether warm water footbaths with added ginger powder can improve thermoregulatory processes in adolescent anorexia nervosa patients and provide them with an increase in subjective feeling of warmth. The participants will receive a warm footbath four times a week for six weeks with a physiological and psychological testing point once before the beginning of the six-week footbath period and once after.
详细描述
This is a two-arm randomized controlled trial to evaluate the efficacy of warm water footbaths with added ginger powder (experimental) compared to warm water only footbaths (control) in adolescent anorexia nervosa patients. Participants will receive footbaths 4 times per week before bed-time over a period of six weeks.The main focus is on subjective increase in overall body warmth. Moreover, core body temperature, skin temperature at the extremities and several psychological as well as physiological scores and parameters are assessed before and after the six-week intervention. A follow-up is planned at six months post intervention, where core body temperature, physiological and psychological parameters are once more tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •main diagnosis: Anorexia nervosa
- •written informed consent of participants and legal guardians
排除标准
- •other eating disorder diagnosis apart from Anorexia nervosa
- •known allergic reaction to ginger
研究组 & 干预措施
Warm water with ginger powder footbath
Experimental
Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period.
干预措施: ginger powder footbath (Other)
Warm water only footbath
Active Comparator
Participants who receive a warm water only footbath four times a week over a six-week period.
干预措施: warm water only footbath (Other)
结局指标
主要结局
Chnge in Subjective feeling of overall warmth
时间窗: Baseline (pre intervention), 6 weeks after baseline (post intervention)
Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire
次要结局
- 24-hour torso surface temperature(Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention))
- pNN50(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- Positive And Negative Affect Schedule(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Face surface temperature(Baseline (pre intervention) and 6 weeks after baseline (post intervention))
- Pittsburgh sleep quality index(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Eating Disorder Inventory -2(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Basler Befindlichkeits Skala(Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up)
- Feet surface temperature(Baseline (pre intervention) and 6 weeks after baseline(post intervention))
- 24-hour hand surface temperature(Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention))
- Peak to Peak Time (PPT)(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- Abdomen surface temperature(Baseline (pre intervention) and after 6 weeks (post intervention))
- 24-hour abdomen surface temperature(Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention))
- Body Mass Index(Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up)
- TimeTX(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- AreaAX(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- AreaAY(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- AreaAV(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- TimeTV(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- MaxT1(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- Pulse Transit Time (PTT)(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- Perfusion Index (PI)(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- SlopeInW1(Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention))
- SlopeInW2(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- SlopeInW3(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- SlopeInW4(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- Stiffness Index(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- QuotTVTW(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- TimeTW(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- MinT2(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- Reflection Index(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- TimeTY(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- QuotTYTX(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- QuotAYAX(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- QuotAWAV(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- MinT1(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- Core body temperature(Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up)
- Hand surface temperature(Baseline (pre intervention) and 6 weeks after baseline(post intervention))
- 24-hour feet surface temperature(Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention))
- AreaAW(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- MaxT2(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- QuotHRRespRate(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- Heart rate(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- Respiratory rate(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- SDNN (standard deviation of normal to normal)(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- RMSSD (Root mean square of successive differences)(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- HF (high frequency)(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention))
- LF (low frequency)(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- LF/HF-Ratio(Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention))
- Eating Disorder Examination- Questionnaire(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Becks Depressions Inventar(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Hospital Anxiety and Depression Scale subscale Anxiety(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Hospital Anxiety and Depression Scale subscale Depression(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Short Form Health Survey 12(Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up)
- Body Shape Questionnaire(Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up)
- Body Image State Scale(Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up)
研究者
研究点 (1)
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