The primary objective of this study is the pain tolerance of linear increasing electric stimuli between music and control setting (podcast), especially looking at the social background. Moreover, comparison of the two music interventions, self-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
acute pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain endurance expressed in amperage.
Secondary outcome
Heart Rate Variability
Anxiety (Stait-Trait-Anxiety-Inventory-6)
Emotions (Self-assessment manikin)
Pain intensity (11-likert numeric rating scale)
Music listening questionnaire
Music genres and characteristics
Background summary
Implementation of music in health care settings has shown to have many
beneficiary effects in regard of stress, anxiety and pain related outcomes.
Most clinical trials show high heterogeneity in regard of music selection and
characteristics. Direct comparisons between different music interventions are
limited. Some research suggests that self-selected or preferred music is more
beneficiary. All in all, it remains unclear which music works best. Moreover,
sociological research shows that music perception depends also on social
background. Therefore, we propose a randomized controlled trial to investigate
the effect of different music on pain tolerance in the context of social
background.
Study objective
The primary objective of this study is the pain tolerance of linear increasing
electric stimuli between music and control setting (podcast), especially
looking at the social background. Moreover, comparison of the two music
interventions, self-chosen and researcher-chosen music, will be performed.
Secondary objects are the effects on anxiety (STAI), emotion (SAM), the
sympathetic-adrenomedullary axis (HRV) and the participants music and pain
perception.
Study design
This study has a randomized cross-over design. Thus, all subjects will receive
the same three interventions in a randomized order.
Intervention
Subjects will receive two music interventions (self-chosen and
researcher-chosen music) and control (podcast) for 20 minutes each. Music will
be given by headphones. Each participant will receive every intervention in a
randomized order. In between *wash-out* periods of 20 minutes will be
established. At the end of each intervention increasing electric stimuli will
be administrated by the participant itself pressing a button.
Study burden and risks
The use of music as intervention has no known deleterious effects on subjects.
Safety precautions will be taken to limit the volume of the music on headphones
(<= 80dB). Burden includes the electric stimulus, which is minimized by safety
precautions and the completion of several safety questionnaires. Measurements
of heart rate variability will be collected with a chest strap which has no
known deleterious effects on subjects. Participation in this study includes one
visit of approximately 2 hours. There is no direct benefit for subjects.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Between 18 and 60 years of age
Female
Sufficient knowledge of the Dutch language to understand the study documents
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
Current treatment by a medical specialist or general practitioner
History of cardiac disease of arrhythmias
(Suspected) pregnancy
Diagnosed psychiatric or neurological impairments
Electric implants (e.g. pacemakers)
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 | NL84165.078.23 |