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Completed

NCT Number: NCT02255916

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

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Music

Other

live sound-bed music intervention

Primary outcomes

  1. Basler Mood Questionnaire (BBS)

    Time frame: 30 minutes

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

Secondary outcomes

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

    Time frame: 30 minutes

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

  2. heart rate variability -Parameter (HRV)

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

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

  3. HRV-Parameter

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

    Root Mean Square of the Successive Differences (RMSSD)

  4. HRV-Parameter

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

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

  5. HRV-Parameter

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

    ratio low frequency to high frequency (LF/HF)

  6. HRV-Parameter

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

    very low frequency (VLF)

  7. HRV-Parameter

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

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

  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)

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

    questionnaire

  10. SF-12 Health Survey

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

  11. Electromyography (EMG)

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

    Electromyography of the shoulder muscles

  12. Skin temperature

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

  13. skin conductance

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

    skin conductance measured at the fingertip

  14. Cortisol

    Time frame: 20 minutes

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

  15. Pulse-Transit-Time (PTT)

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

    Pulse-Transit-Time (ms)

  16. Perfusion-Index (PI)

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

    Perfusion-Index

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study title

Short-term Effects of Live Sound-bed Music on Physiological and Psychological Parameters in Healthy Oncology Staff - A Randomized Controlled Trial With Crossover Design

Acronym: MTO_03

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 3, 2014
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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