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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controll<br>No sound-bed intervention | |
| Experimental: Music<br>live sound-bed music intervention | Other: Music<br>* live sound-bed music intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basler Mood Questionnaire (BBS) | 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 | filled in by the participants four times (before and after the music intervention respectively no intervention) | 30 minutes | 
| heart rate variability -Parameter (HRV) | Standard Deviation of Normal to Normal (heart rate) (SDNN) | Physiological parameters are measured twice over a period of 2 hours. | 
| HRV-Parameter | Root Mean Square of the Successive Differences (RMSSD) | Physiological parameters are measured twice over a period of 2 hours. | 
| HRV-Parameter | pNN50 (the proportion of NN50 divided by total number of NNs) | Physiological parameters are measured twice over a period of 2 hours. | 
| HRV-Parameter | ratio low frequency to high frequency (LF/HF) | Physiological parameters are measured twice over a period of 2 hours. | 
| HRV-Parameter | very low frequency (VLF) | Physiological parameters are measured twice over a period of 2 hours. | 
| HRV-Parameter | 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 |  | filled in by the participants as baseline measurement at the beginning | 
| Sense of Coherence (SOC-13) | questionnaire | filled in by the participants as baseline measurement at the beginning | 
| SF-12 Health Survey |  | filled in by the participants as baseline measurement at the beginning | 
| Electromyography (EMG) | Electromyography of the shoulder muscles | Physiological parameters are measured twice over a period of 2 hours. | 
| Skin temperature |  | Physiological parameters are measured twice over a period of 2 hours. | 
| skin conductance | skin conductance measured at the fingertip | Physiological parameters are measured twice over a period of 2 hours. | 
| Cortisol | via the saliva of the participants before and after the music intervention respectively no intervention | 20 minutes | 
| Pulse-Transit-Time (PTT) | Pulse-Transit-Time (ms) | Physiological parameters are measured twice over a period of 2 hours | 
| Perfusion-Index (PI) | Perfusion-Index | Physiological parameters are measured twice over a period of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oncology, psychology, cancer, music, sound-bed