Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths
- Conditions
- Adolescent Anorexia Nervosa
- Interventions
- Other: ginger powder footbathOther: warm water only footbath
- Registration Number
- NCT03886207
- Lead Sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
- main diagnosis: Anorexia nervosa
- written informed consent of participants and legal guardians
- other eating disorder diagnosis apart from Anorexia nervosa
- known allergic reaction to ginger
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Warm water with ginger powder footbath ginger powder footbath Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period. Warm water only footbath warm water only footbath Participants who receive a warm water only footbath four times a week over a six-week period.
- Primary Outcome Measures
Name Time Method Chnge in Subjective feeling of overall warmth 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
- Secondary Outcome Measures
Name Time Method Core body temperature Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up Core body temperature measured using an infrared tympanical thermometer as used in clinical routine
Hand surface temperature Baseline (pre intervention) and 6 weeks after baseline(post intervention) Surface temperature on the hands measured using high-resolution infrared thermography
24-hour feet surface temperature Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention) 24 hour surface temperature at the feet measured using a surface data-logger (i-Button TM)
Face surface temperature Baseline (pre intervention) and 6 weeks after baseline (post intervention) Surface temperature in the face measured using high-resolution infrared thermography
Feet surface temperature Baseline (pre intervention) and 6 weeks after baseline(post intervention) Surface temperature at the feet measured using high-resolution infrared thermography
24-hour hand surface temperature Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) 24 hour surface temperature on the hands measured using a surface data-logger (i-Button TM)
24-hour torso surface temperature Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) 24 hour surface temperature at the upper torso measured using a surface data-logger (i-Button TM)
Peak to Peak Time (PPT) Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100
Abdomen surface temperature Baseline (pre intervention) and after 6 weeks (post intervention) Surface temperature at the abdomen measured using high-resolution infrared thermography
24-hour abdomen surface temperature Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) 24 hour surface temperature at the abdomen measured using a surface data-logger (i-Button TM)
Body Mass Index Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up Body Mass Index (BMI) Calculated as (Weight in Kg)/〖(Height in m)\^2〗
TimeTX Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) TimeTX in ms (millisecond), measured with the GeTeMed Vitaguard 3100
AreaAX Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
AreaAY Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
AreaAV Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Measured with the GeTeMed Vitaguard 3100
TimeTV Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) TimeTV in ms, measured with the GeTeMed Vitaguard 3100
MaxT1 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the first peak
Pulse Transit Time (PTT) Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) PTT in ms, measured with the GeTeMed Vitaguard 3100
Perfusion Index (PI) Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) PI, measured with the GeTeMed Vitaguard 3100
SlopeInW1 Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention) Measured with the GeTeMed Vitaguard 3100
SlopeInW2 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
SlopeInW3 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
SlopeInW4 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Measured with the GeTeMed Vitaguard 3100
Stiffness Index Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
QuotTVTW Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
TimeTW Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) TimeTW in ms, measured with the GeTeMed Vitaguard 3100
MinT2 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Reflection Index Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
TimeTY Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) TimeTY in ms, measured with the GeTeMed Vitaguard 3100
QuotTYTX Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Measured with the GeTeMed Vitaguard 3100
QuotAYAX Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Measured with the GeTeMed Vitaguard 3100
QuotAWAV Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
MinT1 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Pittsburgh sleep quality index Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Scores of the PSQI (Pittsburgh sleep quality index)
Eating Disorder Inventory -2 Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Scores of the EDI-2 (Eating Disorder Inventory)
Basler Befindlichkeits Skala Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up Scores of the BBS (Basler Befindlichkeits Skala =basler mood questionnaire)
AreaAW Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Measured with the GeTeMed Vitaguard 3100
MaxT2 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the second peak
QuotHRRespRate Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100
Heart rate Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) beats per minute (bpm) measured with the GeTeMed Vitaguard 3100
Respiratory rate Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) measured with the GeTeMed Vitaguard 3100
SDNN (standard deviation of normal to normal) Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Standard deviation of normal to normal beats, measured with the GeTeMed Vitaguard 3100
RMSSD (Root mean square of successive differences) Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Root mean square of successive differences, measured with the GeTeMed Vitaguard 3100
pNN50 Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Number of pairs of successive heart rate intervals that differ by more than 50 ms
HF (high frequency) Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) Area under the curve between the frequency of 0.15 to 0.4Hz measured with the GeTeMed Vitaguard 3100
LF (low frequency) Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) Area under the curve between the frequency of 0.04 to 0.15Hz measured with the GeTeMed Vitaguard 3100
LF/HF-Ratio Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) 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
Eating Disorder Examination- Questionnaire Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Scores of the EDE-Q (Eating Disorder Examination)
Becks Depressions Inventar Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Scores of the BDI-II (Becks Depression Inventar)
Hospital Anxiety and Depression Scale subscale Anxiety Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Anxiety Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at \>10 (being evaluated as pathological)
Hospital Anxiety and Depression Scale subscale Depression Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Depression Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at \>10 (being evaluated as pathological)
Short Form Health Survey 12 Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Scores of the SF-12 (Short Form 12)
Body Shape Questionnaire Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up Scores of the BSQ (Body Shape Questionnaire)
Body Image State Scale Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up 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)
Positive And Negative Affect Schedule Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up Scores of the PANAS-X (Positive and negative affect schedule)
Trial Locations
- Locations (1)
ARCIM Institute
🇩🇪Filderstadt, Baden Württemberg, Germany