Pain, Analgesia
Conditions
Keywords
music, pain, analgesia, music-induced analgesia, socioeconomic status, cultural capital
Brief summary
This study will investigate the effect of different music on the pain tolerance during an increasing electric stimulus in healthy individuals, taking social background into account.
Detailed description
The implementation of music in health care settings has shown promising results in alleviating stress, anxiety, and pain-related outcomes. However, the heterogeneity in music selection and characteristics across clinical trials has made it difficult to draw direct comparisons between different music interventions. Additionally, the influence of social background on music perception remains largely unexplored, despite its potential significance. Therefore, a collaboration of medical and sociological experts propose a randomized controlled trial to investigate the effects of two different music interventions on pain tolerance, taking into account the participants' social backgrounds. The primary objective of this study is to assess the impact of self-chosen and researcher-chosen music compared to a control intervention (podcast) on pain tolerance among healthy female volunteers at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.
Interventions
OTHERListening to music
All participants will listen to self-chosen or researcher-chosen music with noise-cancelling headphones (JBL Tune 770NC). The music will be administered for 20 minutes before participants receive increasing electric pain stimuli.
OTHERListening to a podcast
ln the control condition, participants will listen to a podcast with noise-cancelling headphones (JBL Tune 770NC). The podcast will be administered for 20 minutes before participants receive increasing electric pain stimuli.
Sponsors
Erasmus University Rotterdam
Markus Klimek
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance.
Intervention model description
This randomized controlled trial will have a Latin-square design and investigates the effect of self-chosen music and researcher-chosen music. Each participant will receive the same three interventions (self-chosen music, researcher-chosen music and control) in a randomized order. Listening to an informative podcast will serve as a control condition. During each intervention subjects will receive electric stimuli (experimental phase). The highest electric stimuli to tolerate (pain tolerance) will be detected. Each experimental phase will last 20 minutes and in between a wash-out period of 20 minutes will be completed.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 60 years of age * Female * 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 * 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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain tolerance in amperage | During the intervention, after listening 20 minutes to the music/ podcast. Measured at the same day as the experiment. | The primary object of this study is the pain tolerance by increasing electric stimuli. The measurement will be performed after each intervention while participants are still listening to the music or podcast. Each measurement will be performed three times. Results will be reported in amperage and analyzed with an explorative approach looking at social background. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain unpleasantness | Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment. | Pain unpleasantness will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain unpleasantness. |
| Heart rate variability (HRV) | During the intervention. Measured at the same day as the experiment. | HRV, the variation in time between adjacent heartbeats, can be used as a marker for autonomic function. Furthermore, an increase of HRV has been found after music interventions, possibly due to the effect on the parasympatic nervous system. HRV will be measured continuously using an Acentas Chest Strap (BM innovations GmbH). |
| Anxiety measured with State-Trait Anxiety Inventory (STAI)-6 | At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment. | The STAI-6 questionnaire is a validated and frequently used questionnaire to assess anxiety. The questionnaire comprises six items and the total scores ranges from 20 to 80, with higher score indicating a higher level of anxiety. |
| Pain intensity | Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment | Pain intensity will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain intensity. |
| Music listening Questionnaire | Immediately after the completion of all interventions. Measured at the same day as the experiment. | This questionnaire will consist of four items. Participants will be asked to indicate which type of music they believe was the most and least effective for managing pain, and whether they have an explanation for this. Additionally, we will ask for their opinion of the podcast (control condition) and elaborate in which extend the podcast helped to alleviate the pain. |
| Music gernes and characteristics | Immediately after the completion of all interventions. Measured at the same day as the experiment. | The self-chosen and researcher-chosen music will be assessed and compared using the Spotify® Application Programming Interface (API). |
| Affective reaction measures with Self-Assessment Manikin (SAM) | At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment. | The SAM is a non-verbal pictorial assessment technique that directly measures the pleasure, arousal, and dominance associated with a person's affective reaction to a wide variety of stimuli. Each measurement value ranges from 1 to 9, which indicates different levels of pleasure, arousal and dominance. |
Countries
Netherlands
Outcome results
None listed