An interventional study of Listening to music and Listening to a podcast in Pain and Analgesia, sponsored by Markus Klimek. Completed at 1 site in Netherlands. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by Markus Klimek · Not applicable, Interventional, and Basic science
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.
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.
This is the only study on the registry with Markus Klimek as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The self-chosen music playlist will be assembled by the participant in advance.
Other: Listening to music
The researcher-chosen music playlists will primarily be composed by the Music as Medicine research group from Erasmus Medical Center, based on current expert opinion. The playlist will be created with the goal to help while experiencing pain based on previous literature.
Other: Listening to music
The choice of podcast will be based on expert opinion of the sociology department of the Erasmus University Rotterdam.
Other: Listening to a podcast
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.
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.
Pain tolerance in amperage
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.
Time frame: During the intervention, after listening 20 minutes to the music/ podcast. Measured at the same day as the experiment.
Pain intensity
Pain intensity will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain intensity.
Time frame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment
Pain unpleasantness
Pain unpleasantness will be measured using the Numeric Rating Scale. Values range from 0 to 10, with higher values indicating higher pain unpleasantness.
Time frame: Immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Heart rate variability (HRV)
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).
Time frame: During the intervention. Measured at the same day as the experiment.
Anxiety measured with State-Trait Anxiety Inventory (STAI)-6
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.
Time frame: At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Affective reaction measures with Self-Assessment Manikin (SAM)
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.
Time frame: At baseline and immediately after each increasing electric pain stimuli. Measured at the same day as the experiment.
Music listening Questionnaire
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.
Time frame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
Music gernes and characteristics
The self-chosen and researcher-chosen music will be assessed and compared using the Spotify® Application Programming Interface (API).
Time frame: Immediately after the completion of all interventions. Measured at the same day as the experiment.
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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