Trial document





This trial has been registered retrospectively.
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  DRKS00006137

Trial Description

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Title

Music therapy in palliative care - Psychophysiological effects of a music-based relaxation intervention

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Music therapy is one of the most commonly used complementary therpies in palliative care. Despite its wide acceptance and positive clinical experiences, the lack of high quality studies impedes an evidence based indication of music therapy in the palliative care field. Therefore, the aim of the present study is to evaluate the psychophysiological effects of a music therapy relaxation intervention on patients' subjective perception of relaxation, well-being, and pain, their autonomous reaction indexed by heart rate variability, and quality of life. The effects of a music therapy relaxation intervention are compared to a verbal relaxation intervention.

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Brief Summary in Scientific Language

Music therapy is one of the most commonly used complementary therpies in palliative care. Despite its wide acceptance and positive clinical experiences, the lack of high quality studies impedes an evidence based indication of music therapy in the palliative care field. Therefore, the aim of the present study is to evaluate the psychophysiological effects of a music therapy relaxation intervention on patients' subjective perception of relaxation, well-being, and pain, their autonomous reaction indexed by heart rate variability, and quality of life.

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Organizational Data

  •   DRKS00006137
  •   2014/07/04
  •   [---]*
  •   yes
  •   Approved
  •   S-406/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   OPS 8-982 Complex Palliative Care Treatment
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Interventions/Observational Groups

  •   Music therapy relaxation intervention
    2 sessions of 30 minutes each over a time period of 3 days (total intervention time: 1h)
  •   Verbal relaxation intervention via headphones
    2 sessions of 30 minutes each over a time period of 3 days (total intervention time: 1h)
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Characteristics

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

Subjective perception of:
- relaxation
- well-being
- pain

(VAS pre-post, respectively)

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Secondary Outcome

Heart rate variability during the intervention (30 min. continous measurement)

Health-related quality of life: EORTC QLQ-C15-PAL
baseline to follow up (after completion of the second session)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/05/01
  •   84
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Palliative care according to OPS-8-982
Sufficient understanding of German or English language

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Exclusion Criteria

terminal/prefinal phase
cognitive impairments (e.g. brain metastases)
apallic syndrome
deafness

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentrum für Schmerztherapie und Palliativmedizin Klinik für Anaesthesiologie Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Hubert J.  Bardenheuer 
    • Im Neuenheimer Feld 131
    • 69120  Heidelberg
    • Germany
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    • SRH Hochschule Heidelberg
    • Mr.  Dipl.-Psych.  Marco  Warth 
    • Maria-Probst-Straße 3
    • 69123  Heidelberg
    • Germany
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    • SRH Hochschule Heidelberg
    • Mr.  Dipl.-Psych.  Marco  Warth 
    • Maria-Probst-Straße 3
    • 69123  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Schmerztherapie und Palliativmedizin Klinik für Anaesthesiologie Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Hubert J.  Bardenheuer 
    • Im Neuenheimer Feld 131
    • 69120 
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/10
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Trial Publications, Results and other Documents

  •   Warth, M., Keßler, J., Hillecke, T.K. & Bardenheuer, H.J. (in press). Rezeptive Musiktherapie in der Palliativmedizin - Eine randomisiert kontrollierte Studie zur Beurteilung entspannungsfördernder Effekte. Deutsches Ärzteblatt.
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* This entry means the parameter is not applicable or has not been set.