Trial document




drksid header

  DRKS00015308

Trial Description

start of 1:1-Block title

Title

„Song of Life (SOL)“: A multicenter, randomized trial on the emotional, spiritual, and psychobiological effects of music therapy in palliative care

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PAL-SOL

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients facing a terminal disease in palliative care commonly report high emotional and spiritual needs. Still, scientifically evaluated psychosocial treatments are rare. The present study therefore aims to evaluate the effectiveness of a newly developed music therapy technique (“Song of Life”; SOL) with regard to emotional and spiritual aspects of quality of life. Additionally, biopsychological stress markers will be investigated. Both patients and caregivers will be asked to provide feedback about the treatment. The effects of the music therapy will be compared to the ones of live guided relaxation exercises.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Patients facing a terminal disease in palliative care commonly report high emotional and spiritual needs. Still, scientifically evaluated psychosocial treatments are rare. The present study therefore aims to evaluate the effectiveness of a newly developed music therapy technique (“Song of Life”; SOL) with regard to quality of life, spiritual well-being, ego-integrity and distress. Additionally, biopsychological stress markers will be investigated through saliva samples (cortisol, alpha-amylase) as well as measurements of heart rate variability and peripheral blood flow. Both patients and caregivers will be asked to provide feedback about the treatment. The effects of the music therapy will be compared to the ones of live guided relaxation exercises.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015308
  •   2018/09/07
  •   [---]*
  •   yes
  •   Approved
  •   S-398/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Patients with a terminal disease receiving palliative care
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Music therapy "Song of Life"
    3 sessions of 20-30 minutes each within one week (total intervention time max. 1.5 hours)
  •   Live guided relaxation exercises
    3 sessions of 20 minutes each within one week (total intervention time 1 h)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Psychological dimension of quality of life (McGill Quality of Life Questionnaire Revised; MQOL-R; pre-post-assessment)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Patients

a) Spiritual well-being (Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; FACIT-Sp; pre-post-assessment)
b) Ego-integrity (Brief Measure of Generativity and Ego-Integrity; pre-post-assessment)
c) Global quality of life (McGill Quality of Life Questionnaire Revised; MQOL-R; pre-post-assessment)

d) Distress (NCCN Distress Thermometer; before and after each intervention session)

e) Psychobiological markers of stress through saliva samples (cortisol and alpha-amylase) as well as photoplethysmographic measurements (heart rate variability, peripheral blood flow); before, during and after the intervention

f) Retrospective evaluation of intervention (Feedback Questionnaire and qualitative interview; post-assessment)

Caregivers

Retrospective evaluation of intervention (Feedback Questionnaire and qualitative interview; post- and follow-up-assessment after 8-16 weeks)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/12/03
  •   104
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients

a) Palliative care according to OPS 8 982/OPS 8.98e or estimated life expectancy < 12 months
b) Age ≥ 18 years
c) Ability to provide informed consent
d) Sufficient German language skills
d) Clinical estimation of life expectancy > 1 week


Caregivers

a) Age ≥ 18 years
b) Sufficient German language skills

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients

- Cognitive or auditive impairment (including severe psychiatric symptoms)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Zentrum für Schmerztherapie und Palliativmedizin, Klinik für Anästhesiologie, UniversitätsKlinikum Heidelberg
    • Mr.  Priv.-Doz. Dr.  Jens  Keßler 
    • Im Neuenheimer Feld 131
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Interdisziplinäre Abteilung für Palliativmedizin, Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
    • Mr.  Prof. Dr. med.  Martin  Weber 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Medizinische Psychologie, Zentrum für Psychosoziale Medizin, UniversitätsKlinikum Heidelberg
    • Mr.  Dr. sc. hum.  Marco  Warth 
    • Bergheimer Straße 20
    • 69115  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Medizinische Psychologie, Zentrum für Psychosoziale Medizin, UniversitätsKlinikum Heidelberg
    • Mr.  Dr. sc. hum.  Marco  Warth 
    • Bergheimer Straße 20
    • 69115  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • H.W. & J. Hector Stiftung
    • Am Schloßberg 2
    • 69469  Weinheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Sonnen-Blau. Gemeinnützige Morgott-Schupp-Stiftung für frühkindliche Erziehung und Palliativversorgung
    • Krögerstraße 2
    • 60313  Frankfurt am Main
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.