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

Adolescent Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886207
• Other study ID #: ANS_03
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: July 2020
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 27, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Anorexia Nervosa
• Anorexia
• Anorexia Nervosa

Intervention

Other:
• ginger powder 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
• warm water only footbath
38-40° C warm water footbath without any additive reaching up to mid-calf level

Locations

Country	Name	City	State
Germany	ARCIM Institute	Filderstadt	Baden Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine	Filderklinik, Filderstadt, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Face surface temperature	Surface temperature in the face measured using high-resolution infrared thermography	Baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	Feet surface temperature	Surface temperature at the feet measured using high-resolution infrared thermography	Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Secondary	Hand surface temperature	Surface temperature on the hands measured using high-resolution infrared thermography	Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Secondary	Abdomen surface temperature	Surface temperature at the abdomen measured using high-resolution infrared thermography	Baseline (pre intervention) and after 6 weeks (post intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	SlopeInW1	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
Secondary	SlopeInW2	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	SlopeInW3	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	SlopeInW4	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Secondary	Stiffness Index	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	Reflection Index	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	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)
Secondary	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)
Secondary	QuotTYTX	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Secondary	AreaAX	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	AreaAY	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	QuotAYAX	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Secondary	AreaAV	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Secondary	AreaAW	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	QuotAWAV	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	QuotTVTW	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Respiratory rate	measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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