ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02255916
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Adults (Hospital Oncology Ward) Physiological Phenomena (e.g.HRV Parameters) Morphology Other: Music Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Controll
No sound-bed intervention
Experimental: Music
live sound-bed music intervention
Other: Music
live sound-bed music intervention




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255916


Locations
Germany
Filderklinik
Filderstadt, Baden-Württemberg, Germany, 70794
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Investigators
Principal Investigator: Jan Vagedes, Dr. ARCIM-Institute

Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT02255916     History of Changes
Other Study ID Numbers: MTO_03
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
oncology
psychology
cancer
music
sound-bed

Additional relevant MeSH terms:
Neoplasms