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

Morphology Clinical Trial

— MTO_03  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255916
• Other study ID #: MTO_03
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: January 12, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Other:
• Music
live sound-bed music intervention

Locations

Country	Name	City	State
Germany	Filderklinik	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

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