Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Adolescent Anorexia Nervosa

Intervention / Treatment
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* Other: ginger powder footbath
* Other: warm water only footbath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: main diagnosis: Anorexia nervosa written informed consent of participants and legal guardians Exclusion Criteria: other eating disorder diagnosis apart from Anorexia nervosa known allergic reaction to ginger

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are age and core body temperature stratified and then randomized to one of the two groups (footbath with warm water with additional ginger powder or warm water only). Assessments are taken before and after the six-week intervention phase as well as at six-month follow-up.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm water with ginger powder footbath<br>Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period. | Other: ginger powder footbath<br>* 38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine<br>|
| Active Comparator: Warm water only footbath<br>Participants who receive a warm water only footbath four times a week over a six-week period. | Other: warm water only footbath<br>* 38-40° C warm water footbath without any additive reaching up to mid-calf level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chnge in Subjective feeling of overall warmth | Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire | Baseline (pre intervention), 6 weeks after baseline (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core body temperature | Core body temperature measured using an infrared tympanical thermometer as used in clinical routine | Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up | 
| Face surface temperature | Surface temperature in the face measured using high-resolution infrared thermography | Baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| Feet surface temperature | Surface temperature at the feet measured using high-resolution infrared thermography | Baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| Hand surface temperature | Surface temperature on the hands measured using high-resolution infrared thermography | Baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| Abdomen surface temperature | Surface temperature at the abdomen measured using high-resolution infrared thermography | Baseline (pre intervention) and after 6 weeks (post intervention) | 
| 24-hour feet surface temperature | 24 hour surface temperature at the feet measured using a surface data-logger (i-Button TM) | Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention) | 
| 24-hour hand surface temperature | 24 hour surface temperature on the hands measured using a surface data-logger (i-Button TM) | Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) | 
| 24-hour abdomen surface temperature | 24 hour surface temperature at the abdomen measured using a surface data-logger (i-Button TM) | Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) | 
| 24-hour torso surface temperature | 24 hour surface temperature at the upper torso measured using a surface data-logger (i-Button TM) | Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) | 
| Body Mass Index | Body Mass Index (BMI) Calculated as (Weight in Kg)/〖(Height in m)^2〗 | Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up | 
| Pulse Transit Time (PTT) | PTT in ms, measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| Perfusion Index (PI) | PI, measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| Peak to Peak Time (PPT) | Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| SlopeInW1 | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention) | 
| SlopeInW2 | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| SlopeInW3 | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| SlopeInW4 | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| Stiffness Index | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| Reflection Index | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| TimeTX | TimeTX in ms (millisecond), measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| TimeTY | TimeTY in ms, measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| QuotTYTX | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| AreaAX | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| AreaAY | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| QuotAYAX | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| AreaAV | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| AreaAW | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| QuotAWAV | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| QuotTVTW | Measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| TimeTV | TimeTV in ms, measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| TimeTW | TimeTW in ms, measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| MinT1 | Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| MinT2 | Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| MaxT1 | Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the first peak | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| MaxT2 | Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the second peak | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| QuotHRRespRate | Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| Heart rate | beats per minute (bpm) measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| Respiratory rate | measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| SDNN (standard deviation of normal to normal) | Standard deviation of normal to normal beats, measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| RMSSD (Root mean square of successive differences) | Root mean square of successive differences, measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| pNN50 | Number of pairs of successive heart rate intervals that differ by more than 50 ms | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| HF (high frequency) | Area under the curve between the frequency of 0.15 to 0.4Hz measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) | 
| LF (low frequency) | Area under the curve between the frequency of 0.04 to 0.15Hz measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| LF/HF-Ratio | Ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz), measured with the GeTeMed Vitaguard 3100 | Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) | 
| Pittsburgh sleep quality index | Scores of the PSQI (Pittsburgh sleep quality index) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Eating Disorder Inventory -2 | Scores of the EDI-2 (Eating Disorder Inventory) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Eating Disorder Examination- Questionnaire | Scores of the EDE-Q (Eating Disorder Examination) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Becks Depressions Inventar | Scores of the BDI-II (Becks Depression Inventar) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Hospital Anxiety and Depression Scale subscale Anxiety | Anxiety Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Hospital Anxiety and Depression Scale subscale Depression | Depression Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Body Image State Scale | Mean of all six item values (range from 0-9) with higher values indicating a positive body image state of the BISS (Body Image State Scale) | Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up | 
| Positive And Negative Affect Schedule | Scores of the PANAS-X (Positive and negative affect schedule) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Short Form Health Survey 12 | Scores of the SF-12 (Short Form 12) | Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up | 
| Basler Befindlichkeits Skala | Scores of the BBS (Basler Befindlichkeits Skala =basler mood questionnaire) | Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up | 
| Body Shape Questionnaire | Scores of the BSQ (Body Shape Questionnaire) | Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia, Footbath, Ginger powder, Thermogenic substances, Thermoregulation, External applications, Anthroposophic medicine, Eating disorders