Duration of Music Interventions and Pain Tolerance (DOMINANT)

Pain, Acute Clinical Trial

— DOMINANT  

Official title:

Duration Of Music Interventions aNd pAiN Tolerance in Healthy Individuals: the DOMINANT Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286137
• Other study ID #: NL82922.078.22
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Erasmus Medical Center
• Contact: Emy S van der Valk Bouman, MD
• Phone: +31646461901
• Email: e.vandervalkbouman[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.

Description:

Music interventions reduce perioperative pain and anxiety. However, it is yet unclear how long music needs to be presented in order to have an effect. Therefore, the investigators would like to propose a pilot randomized controlled trial in order to investigate the optimal duration of musical interventions. The main objective of this study is to investigate the effect of different durations of music interventions on pain tolerance (expressed in amperage). Secondary objectives are to investigate the effects of music duration on heart rate variability (expressed in milliseconds) and subjective measurements of emotions, anxiety and pain. Healthy volunteers (age ≥18 years) will be included, and the study will take place at the outpatient clinic of the Center of Pain Medicine, Erasmus Medical Center, Rotterdam.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Between 18 and 64 years of age

• 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

• History of cardiac disease or arrhythmias

• Current treatment by a medical specialist or general practitioner

• Professional musician or singer (practicing in average >1 hour each day)

• Pregnancy

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Other:
• Listening to music for 1 minute
Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 19 minutes before the 1 minute music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).
• Listening to music for 5 minutes
Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 1 minute through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels. The 15 minutes before the 5 minutes music listening intervention, participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones).
• Listening to music for 20 minutes
Participants will be instructed to make a 20-minute playlist with their own preferred music, using a tablet and a music listening app. That playlist will then be presented on shuffle mode for 20 minutes through headphones provided by the hospital. Volume can be selected by the participants. However, in order to prevent hearing loss the volume cannot exceed 80 decibels.
• Not listening to music
Participants will be instructed to remain seated and are not allowed to do anything else (for example using their phones), for a duration of 20 minutes.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

Basinski K, Zdun-Ryzewska A, Greenberg DM, Majkowicz M. Preferred musical attribute dimensions underlie individual differences in music-induced analgesia. Sci Rep. 2021 Apr 21;11(1):8622. doi: 10.1038/s41598-021-87943-z. — View Citation

Fu VX, Oomens P, Klimek M, Verhofstad MHJ, Jeekel J. The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysis. Ann Surg. 2020 Dec;272(6):961-972. doi: 10.1097/SLA.0000000000003506. — View Citation

Howlin C, Stapleton A, Rooney B. Tune out pain: Agency and active engagement predict decreases in pain intensity after music listening. PLoS One. 2022 Aug 3;17(8):e0271329. doi: 10.1371/journal.pone.0271329. eCollection 2022. — View Citation

Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666. — View Citation

Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17. — View Citation

Lunde SJ, Vuust P, Garza-Villarreal EA, Vase L. Music-induced analgesia: how does music relieve pain? Pain. 2019 May;160(5):989-993. doi: 10.1097/j.pain.0000000000001452. No abstract available. — View Citation

Martin-Saavedra JS, Vergara-Mendez LD, Pradilla I, Velez-van-Meerbeke A, Talero-Gutierrez C. Standardizing music characteristics for the management of pain: A systematic review and meta-analysis of clinical trials. Complement Ther Med. 2018 Dec;41:81-89. doi: 10.1016/j.ctim.2018.07.008. Epub 2018 Jul 11. — View Citation

Valevicius D, Lepine Lopez A, Diushekeeva A, Lee AC, Roy M. Emotional responses to favorite and relaxing music predict music-induced hypoalgesia. Front Pain Res (Lausanne). 2023 Oct 25;4:1210572. doi: 10.3389/fpain.2023.1210572. eCollection 2023. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain tolerance	The primary objective of the study is the pain tolerance. This tolerance will be measured using electric stimuli directly after the 20 minutes of listening to music or sitting in silence. Each measurement will be performed three times. Results will be expressed in amperage.	At the end of the intervention, after the 20 minutes of listening to music or sitting in silence. Measured at the same day as the experiment.
Secondary	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).	During the 20 minutes of listening to music or sitting in silence, and during the eletric stimuli directly after those 20 minutes. Measured at the same day as the experiment.
Secondary	Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire	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 a higher score indicating a higher level of anxiety.	At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.
Secondary	Valence and arousal, Self-Assessment manikin (SAM) questionnaire	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.	At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.
Secondary	Music listening Questionnaire	This questionnaire will consist of 7 open questions about music importance and music listening behavior. Participants will be asked to what extend they are a lover of music from a scale of 1 to 7, where a higher value is a higher amout of loving music. Next, participants will be asked how many minutes per day they listen actively and passively to music. Finally, participants will be asked in open questions about their favorite genres, their favorite moments of listening to music, if they play an instrument and if there is music that they dislike.	At baseline. Measured at the same day as the experiment.
Secondary	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.	At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.
Secondary	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.	At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.