Trial document




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  DRKS00013301

Trial Description

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Title

Art therapy to regulate hypertension - a quantitative, controlled study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study aims to evaluate an art therapy method especially developed for patients with hypertension. The therapy comprises a series of painting exercises with watercolour. In a preliminary study with 6 patients this therapy had a positive effect in patients with hypertension, i.e., blood pressure decreased.
In the present study 30 patients with hypertension attend art therapy for 8 weeks, 5 to 6 patients at a time. Before and after the therapy a state inventory questionnaire has to be completed and an overnight ECG is recorded with a small device. At the beginning and the end of each art therapy session the blood pressure is measured.
In addition to the blood pressure data, heart rate variability (HRV) parameters are calculated from the ECG. These data are used to assess blood pressure, cardiac autonomic regulation and sleep quality in the course of the therapy. The control group consists of a waiting group, i.e. no art therapy is applied at the time the treatment group performs art therapy. The treatment group will be followed up after four months. The control group will have art therapy after the treatment group has finished. There will be four therapy locations: Bonn, Alfter, Cologne and Aachen.
The study is a collaboration between Alanus Hochschule/Alfter and the University of Witten/Herdecke.

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Brief Summary in Scientific Language

This study attempts to evaluate a manualized art therapy intervention, developed for arterial hypertension. The intervention consists of a series of artistic exercises with red and blue watercolours. Small groups of 5 to 6 patients will be treated by five different art therapists. The manual was tested in a preliminary study in 2014 on 6 patients with hypertension and showed positive on blood pressure. In particular, systolic and diastolic blood pressure decreased in the course of the art therapy.
In the present study, 60 patients with hypertension will be recruited and randomized into two groups. The treatment group receives the art therapy whereas the control group is a waiting group. The control group will receive the same art therapy after the therapy of the treatment group has finished. The treatment group will be followed up six months after the beginning of the art therapy. At the beginning and in the end of each therapy session, the blood pressure is taken. The treatment takes eight weeks, one art therapy session per week. Before and after the treatment there will be an overnight ECG with a mobile Holter device and an internal state questionnaire (HSI) (Koch, Fuchs & Morlinghaus 2007).
These measurements contain information on the leading symptom of hypertension and also on the inner state, the sleep quality and the ability of recovery during nighttime sleep based on the analysis of heart rate variability. The parameters can also be used to assess cardiac autonomic regulation and blood pressure regulation.
The art therapy locations are Bonn, Alfter, Cologne and Aachen.
This is a collaboration between Alanus Hochschule/Alfter and the University of Witten-Herdecke.

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Organizational Data

  •   DRKS00013301
  •   2018/03/12
  •   [---]*
  •   yes
  •   Approved
  •   243/2017, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   Arm1
    - Admission: Questionnaire of inner state (HSI), blood pressure, mobile overnight ECG

    Intervention:
    Manualised art therapy over 8 sessions, once a week:
    - First session: Introduction in the watercolour painting technique, a first free painting, blood pressure before and after painting
    - Session 2-7: Painting of a series of guided themes following the instructions, blood pressure before and after painting
    - Session 8: final painting, blood pressure before and after, overnight ECG, questionnaire of inner state (HSI)
    Follow up:
    - 6 months after the start of the study: blood pressure, overnight ECG, questionnaire as described above.
  •   Arm2
    - Admission: Questionnaire of inner state (HSI), blood pressure, mobile overnight ECG
    Control measurement
    - After 8 weeks parallel to session 8 of the intervention: blood pressure, questionnaire of inner state (HSI) and overnight ECG.
    Intervention:
    6 months after the start of the study, the same therapy protocol as described for the intervention group start. (8 creative art therapy sessions; blood pressure measurements, overnight ECG, questionnaire as described above).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is a decreased blood pressure after the art therapy intervention (RRafter vs. RRbefore). The immediate effects (after therapy vs. before therapy) as well as the medium term improvement of blood pressure will be evaluated (changes between each art therapy session). The long term changes of the inner state will be determined by evaluating the questionnaires (HSI, Heidelberger State Inventoy, Koch, Morlinghaus & Fuchs 2007) at the beginning, in the end of the therapy phase and during the follow up.

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Secondary Outcome

The secondary outcome will be the evaluation of the standard parameters of heart rate variability during three 5-minute-periods (respectively the central 5 minutes before, during and after the art therapy) according to the HRV standards (Task Force of the European Society of Cardiology and The North American Society of Pacing and Electrophysiology 1996):
- The mean RR-interval in milliseconds
- The standard deviation of the normal-to-normal heartbeats (SDNN) in milliseconds
- The square root of the mean squared NN-differences (RMSSD) in milliseconds
- The high frequency component (HF) of spectral analysis (0.15 to 0.4 Hz corresponding 9 to 24 oscillations per minute)
- Low frequency component (LF) of the spectral analysis (0.04 to 0.15 Hz corresponding to 2.4 to 9 oscillations per minute)
The mentioned HRV parameters will be determined for all subsequent 5-minute intervals during nighttime sleep and subsequently averaged. The ability of recovery can be assessed with this method. The decline of the LF-component or the increase of the HF-component of HRV should be considered as an improvement of the cardiac autonomic regulation. The mentioned changes may be interpreted as a reduction of stress (assessed by a decrease of the LF component). The change of these two components should go along with the alteration of SDNN and RMSSD.

Moreover, the physiological sleep quality can be determined from the cardiopulmonary coupling from the overnight ECG (Thomas et al. 2005). Therefore the classification of stable and instable sleep phases by means of the detecion of the high frequency components (stable sleep) and the low frequency components (instable sleep) of cardiopulmonary coupling will be used. An increased physiologic sleep quality and therefore a better ability of recovery of the organism should lead to less phases of instable sleep and more stable sleep phases.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • other 
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Recruitment

  •   Actual
  •   2018/03/20
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   70   Years
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Additional Inclusion Criteria

Adults capable of taking decisions with diagnosed arterial hypertonia, stable blood pressure medication, longterm known medical history and 24h blood pressure mesurement not older than two years.

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Exclusion Criteria

- Cushing’s syndrome, Conn’s syndrome, renal artery stenosis
- diseases affecting the cardiovascular regulation: thyroid dysfunction, coronary heart diseases, diabetes mellitus
- Obesity (body mass index >30)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Kunsttherapie und Therapiewissenschaft
    • Mr.  Prof. Dr. rer. medic.  Harald  Gruber 
    • Villestraße 3
    • 53347  Alfter
    • Germany
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    • Integriertes Begleitstudium Anthroposophische Medizin
    • Mr.  Prof. Dr. rer. nat.  Dirk  Cysarz 
    • Gerhard-Kienle-Weg 4
    • 58313  -herdecke
    • Germany
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    • Institut für künstlerische therapien und Therapiewissenschaft
    • Ms.  Corinne  Roy 
    • Villestraße 3
    • 53347  Alfter
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Kunsttherapie und Therapiewissenschaft
    • Ms.  Corinne  Roy 
    • Viellestraße 3
    • 53347  Alfter
    • Germany
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    • Anthroposophische Gesellschaft Deutschland e.V.Stiftung Forschungsförderung
    • Ms.  Monika  Elbert 
    • Stubenrauchstraße 77
    • 15732  Eichwalde
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Roy, Corinne u. a. (2016): Regulation von arterieller Hypertonie durch Maltherapie, in: Der Merkurstab (2016), S. 50–51
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* This entry means the parameter is not applicable or has not been set.