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Completed

NCT Number: NCT03886207

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

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.

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Key information

Conditions

Adolescent Anorexia Nervosa Anorexia Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

8 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ARCIM Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginger powder footbath

Other

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

Other

38-40° C warm water footbath without any additive reaching up to mid-calf level

Primary outcomes

  1. Chnge in Subjective feeling of overall warmth

    Time frame: 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 outcomes

  1. Core body temperature

    Time frame: 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

  2. Face surface temperature

    Time frame: Baseline (pre intervention) and 6 weeks after baseline (post intervention)

    Surface temperature in the face measured using high-resolution infrared thermography

  3. Feet surface temperature

    Time frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)

    Surface temperature at the feet measured using high-resolution infrared thermography

  4. Hand surface temperature

    Time frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)

    Surface temperature on the hands measured using high-resolution infrared thermography

  5. Abdomen surface temperature

    Time frame: Baseline (pre intervention) and after 6 weeks (post intervention)

    Surface temperature at the abdomen measured using high-resolution infrared thermography

  6. 24-hour feet surface temperature

    Time frame: 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)

  7. 24-hour hand surface temperature

    Time frame: 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)

  8. 24-hour abdomen surface temperature

    Time frame: 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)

  9. 24-hour torso surface temperature

    Time frame: 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)

  10. Body Mass Index

    Time frame: 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〗

  11. Pulse Transit Time (PTT)

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

    PTT in ms, measured with the GeTeMed Vitaguard 3100

  12. Perfusion Index (PI)

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

    PI, measured with the GeTeMed Vitaguard 3100

  13. Peak to Peak Time (PPT)

    Time frame: 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

  14. SlopeInW1

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

    Measured with the GeTeMed Vitaguard 3100

  15. SlopeInW2

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

    Measured with the GeTeMed Vitaguard 3100

  16. SlopeInW3

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

    Measured with the GeTeMed Vitaguard 3100

  17. SlopeInW4

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

    Measured with the GeTeMed Vitaguard 3100

  18. Stiffness Index

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

    Measured with the GeTeMed Vitaguard 3100

  19. Reflection Index

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

    Measured with the GeTeMed Vitaguard 3100

  20. TimeTX

    Time frame: 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

  21. TimeTY

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

    TimeTY in ms, measured with the GeTeMed Vitaguard 3100

  22. QuotTYTX

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

    Measured with the GeTeMed Vitaguard 3100

  23. AreaAX

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

    Measured with the GeTeMed Vitaguard 3100

  24. AreaAY

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

    Measured with the GeTeMed Vitaguard 3100

  25. QuotAYAX

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

    Measured with the GeTeMed Vitaguard 3100

  26. AreaAV

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

    Measured with the GeTeMed Vitaguard 3100

  27. AreaAW

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

    Measured with the GeTeMed Vitaguard 3100

  28. QuotAWAV

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

    Measured with the GeTeMed Vitaguard 3100

  29. QuotTVTW

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

    Measured with the GeTeMed Vitaguard 3100

  30. TimeTV

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

    TimeTV in ms, measured with the GeTeMed Vitaguard 3100

  31. TimeTW

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

    TimeTW in ms, measured with the GeTeMed Vitaguard 3100

  32. MinT1

    Time frame: 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

  33. MinT2

    Time frame: 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

  34. MaxT1

    Time frame: 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

  35. MaxT2

    Time frame: 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

  36. QuotHRRespRate

    Time frame: 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

  37. Heart rate

    Time frame: 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

  38. Respiratory rate

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

    measured with the GeTeMed Vitaguard 3100

  39. SDNN (standard deviation of normal to normal)

    Time frame: 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

  40. RMSSD (Root mean square of successive differences)

    Time frame: 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

  41. pNN50

    Time frame: 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

  42. HF (high frequency)

    Time frame: 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

  43. LF (low frequency)

    Time frame: 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

  44. LF/HF-Ratio

    Time frame: 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

  45. Pittsburgh sleep quality index

    Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up

    Scores of the PSQI (Pittsburgh sleep quality index)

  46. Eating Disorder Inventory -2

    Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up

    Scores of the EDI-2 (Eating Disorder Inventory)

  47. Eating Disorder Examination- Questionnaire

    Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up

    Scores of the EDE-Q (Eating Disorder Examination)

  48. Becks Depressions Inventar

    Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up

    Scores of the BDI-II (Becks Depression Inventar)

  49. Hospital Anxiety and Depression Scale subscale Anxiety

    Time frame: 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)

  50. Hospital Anxiety and Depression Scale subscale Depression

    Time frame: 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)

  51. Body Image State Scale

    Time frame: 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)

  52. Positive And Negative Affect Schedule

    Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up

    Scores of the PANAS-X (Positive and negative affect schedule)

  53. Short Form Health Survey 12

    Time frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up

    Scores of the SF-12 (Short Form 12)

  54. Basler Befindlichkeits Skala

    Time frame: 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)

  55. Body Shape Questionnaire

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • Filderklinik, Filderstadt, Germany

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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