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

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

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

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.

Anorexia, Footbath, Ginger powder, Thermogenic substances, Thermoregulation, External applications, Anthroposophic medicine, Eating disorders

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.

Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period.

38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine

Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire

Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up

Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention)

Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)

Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)

Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)

Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

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

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

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

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

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

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

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

Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)

Anxiety Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)

Depression Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)

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), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up

Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up

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