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CompletedNCT02255916MTO_03Updated Jan 13, 2015

Short-term Effects of Sound-bed Music Therapy in Healthy Caregivers of a Hospital Oncology Ward (MTO_03)

An interventional study of Music in Healthy Adults (Hospital Oncology Ward), Physiological Phenomena (e.g.HRV Parameters) and Morphology, sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-13.

Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the effects of live sound-bed music on physiological and psychological parameters in staff of a hospital oncology ward.

02

Conditions studied

  • Healthy Adults (Hospital Oncology Ward)
  • Physiological Phenomena (e.g.HRV Parameters)
  • Morphology

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Keywords

  • oncology
  • psychology
  • cancer
  • music
  • sound-bed
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine is the lead sponsor of 30 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • signed informed consent of the participant
  • affiliation to the staff of the hospital oncology ward

Exclusion criteria

Exclusion Criteria:

  • insufficient knowledge of the German language
  • alcohol, caffeine or nicotine less than 3 hours before the beginning
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Controll

    No sound-bed intervention

  • Experimental
    Music

    live sound-bed music intervention

    Other: Music

Interventions

  • OtherMusic

    live sound-bed music intervention

06

What researchers measure

Primary outcomes

  1. Basler Mood Questionnaire (BBS)

    filled in by the participants four times (before and after the music intervention respectively no intervention)

    Time frame: 30 minutes

Secondary outcomes

  1. additional questions addressing body warmth, subjective painlessness and general mental state

    filled in by the participants four times (before and after the music intervention respectively no intervention)

    Time frame: 30 minutes

  2. heart rate variability -Parameter (HRV)

    Standard Deviation of Normal to Normal (heart rate) (SDNN)

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  3. HRV-Parameter

    Root Mean Square of the Successive Differences (RMSSD)

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  4. HRV-Parameter

    pNN50 (the proportion of NN50 divided by total number of NNs)

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  5. HRV-Parameter

    ratio low frequency to high frequency (LF/HF)

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  6. HRV-Parameter

    very low frequency (VLF)

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  7. HRV-Parameter

    NN50 (the number of pairs of successive NNs that differ by more than 50 ms)

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  8. Hamilton Anxiety and Depression Scale

    Time frame: filled in by the participants as baseline measurement at the beginning

  9. Sense of Coherence (SOC-13)

    questionnaire

    Time frame: filled in by the participants as baseline measurement at the beginning

  10. SF-12 Health Survey

    Time frame: filled in by the participants as baseline measurement at the beginning

  11. Electromyography (EMG)

    Electromyography of the shoulder muscles

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  12. Skin temperature

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  13. skin conductance

    skin conductance measured at the fingertip

    Time frame: Physiological parameters are measured twice over a period of 2 hours.

  14. Cortisol

    via the saliva of the participants before and after the music intervention respectively no intervention

    Time frame: 20 minutes

  15. Pulse-Transit-Time (PTT)

    Pulse-Transit-Time (ms)

    Time frame: Physiological parameters are measured twice over a period of 2 hours

  16. Perfusion-Index (PI)

    Perfusion-Index

    Time frame: Physiological parameters are measured twice over a period of 2 hours

07

Study locations

1 site
  • Filderklinik
    Filderstadt, Baden-Württemberg 70794, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02255916
Lead sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Responsible party
Sponsor
First posted
Oct 3, 2014
Start date
Sep 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 13, 2015

Study contacts

Jan Vagedes, Dr.
principal investigator · ARCIM-Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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