Clinical trial NCT02255916: Short-term Effects of Sound-bed Music Therapy in Healthy Caregivers of a Hospital Oncology Ward (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults (Hospital Oncology Ward)
Physiological Phenomena (e.g.HRV Parameters)
Morphology
Keywords: oncology
psychology
cancer
music
sound-bed
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Basler Mood Questionnaire (BBS)
timeFrame: 30 minutes
Secondary outcomes:
measure: additional questions addressing body warmth, subjective painlessness and general mental state
timeFrame: 30 minutes
measure: heart rate variability -Parameter (HRV)
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: HRV-Parameter
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: HRV-Parameter
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: HRV-Parameter
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: HRV-Parameter
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: HRV-Parameter
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: Hamilton Anxiety and Depression Scale
timeFrame: filled in by the participants as baseline measurement at the beginning
measure: Sense of Coherence (SOC-13)
timeFrame: filled in by the participants as baseline measurement at the beginning
measure: SF-12 Health Survey
timeFrame: filled in by the participants as baseline measurement at the beginning
measure: Electromyography (EMG)
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: Skin temperature
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: skin conductance
timeFrame: Physiological parameters are measured twice over a period of 2 hours.
measure: Cortisol
timeFrame: 20 minutes
measure: Pulse-Transit-Time (PTT)
timeFrame: Physiological parameters are measured twice over a period of 2 hours
measure: Perfusion-Index (PI)
timeFrame: Physiological parameters are measured twice over a period of 2 hours
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Filderklinik
state: Baden-Württemberg
Study officials:
affiliation: ARCIM-Institute
name: Jan Vagedes, Dr.
role: PRINCIPAL_INVESTIGATOR
References: