The primary objective is to determine the impact of listening to music prior and during receiving electric stimuli on pain enduranceSecondary objectives are to measure how subjective anxiety, HRV, sAA and sCortisol are involved in the management of…
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain endurance (mA)
Secondary outcome
Heart rate variability
Anxiety (VAS anxiety)
Salivary cortisol
Salivary alpha amylase
Sex
Age
Highest level of education
Hand dominance
Medication use
Use of oral contraceptives
Smoking
Use of drugs
Use of alcohol
Anxiety/Depression/PTSD
History of experience with electric pain stimulus models
Importance of music
Background summary
Many studies have investigated the effect of music on pain and stress in a
surgical population. It is unclear whether these results can be extrapolated to
the non-surgical population that also receives many painful medical procedures.
This study will be performed in a controlled setting in order to investigate
the true analgesic effect of music. Also the mechanism of the analgesic of
effect of music is unknown. We will investigate whether the analgesic effect is
due to an increased pain tolerance. Furthermore we will investigate how the
'sympathetic-adrenomedullary'-axis and the
'hypothalamic-pituitary-adrenocortica'-axis are involved in the management of
stressful situations.
Study objective
The primary objective is to determine the impact of listening to music prior
and during receiving electric stimuli on pain endurance
Secondary objectives are to measure how subjective anxiety, HRV, sAA and
sCortisol are involved in the management of this painful event with and without
music.
Study design
Parallel randomized controlled trial, with two study arms
Intervention
Music
Study burden and risks
Participants only have to visit the Erasmus MC once. Their visit will take up
to 1.5 hours. The study will be terminated prematurely in case of strong
signals of negative influence of music intervention or electric stimuli on
multiple subjects. The risk of music is negligible as recent meta-analysis
showed no side-effects of recorded music through headphones
Furthermore, the risk of the electric stimuli is minimized by the fact that the
stimuli give a maximum current of 20mA. Moreover for safety the program is made
so that the patient never can start a second stimulus after one other without
the researcher releases the signal in the meantime and there is both an
emergency button in *Stimusol* and a physical, red stop button that can be
pressed by the participant or researcher.
Wytemaweg 80 80
Rotterdam 3015CN
NL
Wytemaweg 80 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
- Adult (age *18 years and < 70 years)
- Good 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 impairments, impeding listening to music.
- Current use of analgesic, anti-depressant, anti-anxiety medication,
antihypertensive medication.
- Current treatment by a medical specialist or general practitioner.
- Current (suspected) pregnancy.
- Severe mental or psychiatric disorder.
- Presence of pain complaints, such as acute pain, myalgia, or presence of a
chronic pain syndrome (defined as ongoing pain lasting longer
than 3 months).
- Current complaints of tinnitus.
- Medical history of cardiac rhythm disorders.
- Current use of corticosteroids.
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 | NL74554.078.20 |