The main objective is to investigate the effect of different durations of music interventions on pain endurance. Secondary objectives are to investigate the effects of music duration on heart rate variability and subjective measurements of emotions…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is pain endurance (expressed in amperage).
Secondary outcome
Secundary endpoints are heart rate variability (expressed in milliseconds) and
subjective measurements of emotions, anxiety and pain.
Background summary
Music interventions reduce perioperative pain and anxiety. A recent study shows
that healthy participants seem less susceptible to acute pain when listening to
music. However, it is yet unclear how long music needs to be presented in order
to have an effect. Therefore, we would like to propose a pilot randomized
controlled trial in order to investigate the optimal duration of musical
interventions.
Study objective
The main objective is to investigate the effect of different durations of music
interventions on pain endurance. Secondary objectives are to investigate the
effects of music duration on heart rate variability and subjective measurements
of emotions, anxiety and pain.
Study design
This study will be performed as a pilot randomized controlled trial.
Intervention
Respectively 1, 20 and 40 minutes of patient preferred music presented through
headphones.
Study burden and risks
Music as an intervention is not known to have a negative effect on subjects.
The volume of the music will not exceed 80 decibels. The burden includes the
electric stimuli. Negative consequences are minimized by taking safety
precautions. Participation in this study includes one outpatient visit of
approximately 60 minutes. There is no direct benefit for the subjects.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
>= 18 years of age
Sufficient knowledge of the Dutch language to understand the study documents
(in the judgement of the attending physician or researcher)
Provision of written informed consent by subject
Exclusion criteria
Significant hearing impairment
Current complaints of tinnitus
Current use of analgesic medication
Presence of acute or chronic pain
History of cardiac disease or arrhythmia
Current treatment by a medical specialist or general practitioner
Active or professional musician or singer
Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82922.078.22 |