An interventional study of ginger powder footbath and warm water only footbath in Adolescent Anorexia Nervosa, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to female participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Not applicable, Interventional, and Treatment
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.
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 24 is below the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →ARCIM Institute Academic Research in Complementary and Integrative Medicine is the lead sponsor of 30 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period.
Other: ginger powder footbath
Participants who receive a warm water only footbath four times a week over a six-week period.
Other: warm water only footbath
38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine
38-40° C warm water footbath without any additive reaching up to mid-calf level
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
Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention)
Core body temperature
Core body temperature measured using an infrared tympanical thermometer as used in clinical routine
Time frame: 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
Time frame: Baseline (pre intervention) and 6 weeks after baseline (post intervention)
Feet surface temperature
Surface temperature at the feet measured using high-resolution infrared thermography
Time frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Hand surface temperature
Surface temperature on the hands measured using high-resolution infrared thermography
Time frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Abdomen surface temperature
Surface temperature at the abdomen measured using high-resolution infrared thermography
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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〗
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SlopeInW1
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
SlopeInW2
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW3
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW4
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Stiffness Index
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Reflection Index
Measured with the GeTeMed Vitaguard 3100
Time frame: 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
Time frame: 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
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTYTX
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAX
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
AreaAY
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAYAX
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAV
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAW
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAWAV
Measured with the GeTeMed Vitaguard 3100
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTVTW
Measured with the GeTeMed Vitaguard 3100
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Respiratory rate
measured with the GeTeMed Vitaguard 3100
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up
Plan to share: No
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ARCIM Institute Academic Research in Complementary and Integrative Medicine