Trial document





This trial has been registered retrospectively.
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  DRKS00004164

Trial Description

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Title

Improvements of physiological parameters after one single Rhythmical Massage intervention in stressed adults – a prospective, randomised, single-blinded Study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The goal of this first randomised, controlled, single-blinded trial was to evaluate the effects of a single Rhythmical Massage (RTM) intervention compared to a standardised sham massage group (SM) in healthy adults. Additionally, olfactory effects have been assessed through a comparison with a RTM group with aroma oil (RA) and without aroma oil (RM). All participants were randomised into the three groups in a balanced gender ratio and recruited through advertising at a university hospital. All subjects were exposed to an experimental strained situation, the Trier Social Stress Test (TSST), before receiving a single massage intervention of about 60 minutes incl. 20 minutes of rest period. Primary hypothesis was an additive effect of RM and RA, with 90% of the total effect attributable to RM and 10% to RA.

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Brief Summary in Scientific Language

Healthy adults were randomised to one of three groups (RM, RA or SM). Data assessment took place over a period of three hours in addition to a measurement of a 24-hour electrocardiogram. All participants were instructed not to drink coffee, alcohol or to eat three hours prior to the beginning of the study. Appointments were given between 7am and 11am. Initially, the salivary cortisol was collected for the first time and participants had to answer the first questionnaire (baselineparameters, TICS). Afterwards, the Trier Social Stress Test (TSST) was conducted in an adjoining room with two assistants followed by the second questionnaire (MDBF, BF-S, B-L & VAS). Before and after 20 minutes of massage, the second and third salivary cortisol sample was collected. After another 10 minutes of massage and 20 minutes of rest, the fourth and fifth salivary cortisol sample took place. Finally, participants responded to the third questionnaire (MDBF, BF-S, B-L & VAS). Prior to the beginning of the massage and afterwards we assessed 30 minutes of finger-bloodpressure.

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Organizational Data

  •   DRKS00004164
  •   2012/05/25
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  •   yes
  •   Approved
  •   EA4/116/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Stress
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Interventions/Observational Groups

  •   Participants were exposed to an experimental strained situation, the Trier Social Stress Test (TSST), before receiving a single Rhythmical massage intervention with aroma oil (lavender and turf) of about 60 minutes incl. 20 minutes of rest period
  •   Participants were exposed to an experimental strained situation, the Trier Social Stress Test (TSST), before receiving a single Rhythmical massage intervention with neutral oil (jojoba oil) of about 60 minutes incl. 20 minutes of rest period
  •   Participants were exposed to an experimental strained situation, the Trier Social Stress Test (TSST), before receiving a single sham massage intervention with neutral oil (jojoba oil) of about 60 minutes incl. 20 minutes of rest period
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Placebo, Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

heart rate variability was assessed over a period of 24 hours; the assessment of the fingerbloodpressure took place prior to the massage and after over a period of 30 minutes; salivary cortisol was assessed five times prior to, during and after the massage

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Secondary Outcome

Following questionnaires were assessed prior to the massage and afterwards:
existential orientation Scale from von Zerssen (Befindlichkeitsliste); list of somatic complaints from von Zerssen (Beschwerdeliste); multidimensional questionnaire on existential orientation by Steyer (Mehrdimensionaler Befindlichkeitsfragebogen); visual analog scales

All questionnaires assess the actual well-being and are therefore valid assessments of short-term effects in therapy trials.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/01/20
  •   123
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

participants had to give written informed consent in participating and the transfer of their data under a pseudonym

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Exclusion Criteria

acute and chronic diseases or other severe psychiatric comorbidity that could affect their participation

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Addresses

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    • Charité - Universitätsmedizin Berlin
    • Mr.  Dr. med.  Georg  Seifert 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Dr. med.  Georg  Seifert 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Ms.  Jenny Lena  Kanitz 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Dr. Hauschka Stiftung
    • 73085  Bad Boll/ Eckwalden
    • Germany
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    • Software AG Stiftung
    • Am Einchwäldchen 6
    • 64297  Darmstadt
    • Germany
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    • Christophorus Stiftung in der GLS Treuhand e.V.
    • Kernerplatz 2
    • 70182  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/05/03
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.