Healthy Adults (Hospital Oncology Ward)MTO_03NCT02255916
Short-term Effects of Sound-bed Music Therapy in Healthy Caregivers of a Hospital Oncology Ward (MTO_03)
A study testing Music in people with Healthy Adults (Hospital Oncology Ward) and Physiological Phenomena (e.g.HRV Parameters), run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults (Hospital Oncology Ward), Physiological Phenomena (e.g.HRV Parameters), Morphology
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- signed informed consent of the participant
- affiliation to the staff of the hospital oncology ward
Who cannot join
- insufficient knowledge of the German language
- alcohol, caffeine or nicotine less than 3 hours before the beginning
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Adults (Hospital Oncology Ward), Physiological Phenomena (e.g.HRV Parameters), Morphology
- Being tested
- Music
- Keywords
- oncology, psychology, cancer, music, sound-bed
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
live sound-bed music intervention
| Study group | Role | What they receive |
|---|---|---|
| Controll | No intervention | No sound-bed intervention |
| Music | Experimental | live sound-bed music intervention Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basler Mood Questionnaire (BBS)
filled in by the participants four times (before and after the music intervention respectively no intervention)
Measured: 30 minutes
Secondary outcomes (16)
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)
Measured: 30 minutes
heart rate variability -Parameter (HRV)
Standard Deviation of Normal to Normal (heart rate) (SDNN)
Measured: Physiological parameters are measured twice over a period of 2 hours.
HRV-Parameter
Root Mean Square of the Successive Differences (RMSSD)
Measured: Physiological parameters are measured twice over a period of 2 hours.
HRV-Parameter
pNN50 (the proportion of NN50 divided by total number of NNs)
Measured: Physiological parameters are measured twice over a period of 2 hours.
HRV-Parameter
ratio low frequency to high frequency (LF/HF)
Measured: Physiological parameters are measured twice over a period of 2 hours.
HRV-Parameter
very low frequency (VLF)
Measured: 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)
Measured: Physiological parameters are measured twice over a period of 2 hours.
Hamilton Anxiety and Depression Scale
Measured: filled in by the participants as baseline measurement at the beginning
Sense of Coherence (SOC-13)
questionnaire
Measured: filled in by the participants as baseline measurement at the beginning
SF-12 Health Survey
Measured: filled in by the participants as baseline measurement at the beginning
Electromyography (EMG)
Electromyography of the shoulder muscles
Measured: Physiological parameters are measured twice over a period of 2 hours.
Skin temperature
Measured: Physiological parameters are measured twice over a period of 2 hours.
skin conductance
skin conductance measured at the fingertip
Measured: 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
Measured: 20 minutes
Pulse-Transit-Time (PTT)
Pulse-Transit-Time (ms)
Measured: Physiological parameters are measured twice over a period of 2 hours
Perfusion-Index (PI)
Perfusion-Index
Measured: Physiological parameters are measured twice over a period of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adults (Hospital Oncology Ward)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr., Principal investigator, ARCIM-Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255916
- Sponsor's protocol ID
- MTO_03
- Acronym
- MTO_03
- Status last verified
- Jan 2015
- First submitted
- 9 Sep 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02255916
- Acronym / sponsor ID
- MTO_03 / MTO_03
- Conditions
- Healthy Adults (Hospital Oncology Ward), Physiological Phenomena (e.g.HRV Parameters), Morphology
- Keywords
- oncology, psychology, cancer, music, sound-bed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controll | No intervention | –No sound-bed intervention |
| Music | Experimental | Other: Musiclive sound-bed music intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- signed informed consent of the participant
- affiliation to the staff of the hospital oncology ward
Key exclusion criteria (2 listed)
- insufficient knowledge of the German language
- alcohol, caffeine or nicotine less than 3 hours before the beginning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musiclive sound-bed music intervention | Other | Music |
Primary outcome
Basler Mood Questionnaire (BBS)
Time frame: 30 minutes
filled in by the participants four times (before and after the music intervention respectively no intervention)
16 secondary outcomes
additional questions addressing body warmth, subjective painlessness and general mental state
Time frame: 30 minutes
heart rate variability -Parameter (HRV)
Time frame: 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.
HRV-Parameter
Time frame: 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.
HRV-Parameter
Time frame: 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.
Hamilton Anxiety and Depression Scale
Time frame: 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
SF-12 Health Survey
Time frame: 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.
Skin temperature
Time frame: 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.
Cortisol
Time frame: 20 minutes
Pulse-Transit-Time (PTT)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, Dr. principal investigator
ARCIM-Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Healthy Adults (Hospital Oncology Ward) and Physiological Phenomena (e.g.HRV Parameters), run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basler Mood Questionnaire (BBS) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.