MOSART: The Influence of Music Choice on Pain Tolerance in the Context of Social Background

Sponsor

Markus Klimek (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008951

Collaborator

Erasmus University Rotterdam (Other)

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Analgesia	Other: Listening to music Other: Listening to a podcast	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

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.

Primary Purpose:

Basic Science

Official Title:

The Influence of Music Choice on Pain Tolerance in the Context of Social Background in Healthy Volunteers: the MOSART Trial - A Randomized Controlled Trial

Anticipated Study Start Date :

Aug 22, 2023

Anticipated Primary Completion Date :

Aug 22, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-chosen music The self-chosen music playlist will be assembled by the participant in advance.	Other: Listening 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.
Experimental: Researcher-chosen 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 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.
Active Comparator: Podcast (control) The choice of podcast will be based on expert opinion of the sociology department of the Erasmus University Rotterdam.	Other: Listening 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.

Arm

Intervention/Treatment

Experimental: Self-chosen music

The self-chosen music playlist will be assembled by the participant in advance.

Other: Listening 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.

Experimental: Researcher-chosen 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

Active Comparator: Podcast (control)

The choice of podcast will be based on expert opinion of the sociology department of the Erasmus University Rotterdam.

Other: Listening 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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