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

January 12, 2015 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Germany, 70794
        • Filderklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controll
No sound-bed intervention
Experimental: Music
live sound-bed music intervention
Other: Music
live sound-bed music intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basler Mood Questionnaire (BBS)
Time Frame: 30 minutes
filled in by the participants four times (before and after the music intervention respectively no intervention)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 minutes
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)
Physiological parameters are measured twice over a period of 2 hours.
HRV-Parameter
Time Frame: Physiological parameters are measured twice over a period of 2 hours.
Root Mean Square of the Successive Differences (RMSSD)
Physiological parameters are measured twice over a period of 2 hours.
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)
Physiological parameters are measured twice over a period of 2 hours.
HRV-Parameter
Time Frame: Physiological parameters are measured twice over a period of 2 hours.
ratio low frequency to high frequency (LF/HF)
Physiological parameters are measured twice over a period of 2 hours.
HRV-Parameter
Time Frame: Physiological parameters are measured twice over a period of 2 hours.
very low frequency (VLF)
Physiological parameters are measured twice over a period of 2 hours.
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)
Physiological parameters are measured twice over a period of 2 hours.
Hamilton Anxiety and Depression Scale
Time Frame: filled in by the participants as baseline measurement at the beginning
filled in by the participants as baseline measurement at the beginning
Sense of Coherence (SOC-13)
Time Frame: filled in by the participants as baseline measurement at the beginning
questionnaire
filled in by the participants as baseline measurement at the beginning
SF-12 Health Survey
Time Frame: filled in by the participants as baseline measurement at the beginning
filled in by the participants as baseline measurement at the beginning
Electromyography (EMG)
Time Frame: Physiological parameters are measured twice over a period of 2 hours.
Electromyography of the shoulder muscles
Physiological parameters are measured twice over a period of 2 hours.
Skin temperature
Time Frame: Physiological parameters are measured twice over a period of 2 hours.
Physiological parameters are measured twice over a period of 2 hours.
skin conductance
Time Frame: Physiological parameters are measured twice over a period of 2 hours.
skin conductance measured at the fingertip
Physiological parameters are measured twice over a period of 2 hours.
Cortisol
Time Frame: 20 minutes
via the saliva of the participants before and after the music intervention respectively no intervention
20 minutes
Pulse-Transit-Time (PTT)
Time Frame: Physiological parameters are measured twice over a period of 2 hours
Pulse-Transit-Time (ms)
Physiological parameters are measured twice over a period of 2 hours
Perfusion-Index (PI)
Time Frame: Physiological parameters are measured twice over a period of 2 hours
Perfusion-Index
Physiological parameters are measured twice over a period of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Investigators

  • Principal Investigator: Jan Vagedes, Dr., ARCIM-Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTO_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Morphology

Clinical Trials on Music

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe