Duration of Music Interventions and Pain Tolerance (DOMINANT) (DOMINANT)

Duration of Music Interventions and PAiN Tolerance in Healthy Individuals: the DOMINANT Trial

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

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Other: Not listening to music; Other: Listening to music for 1 minute; Other: Listening to music for 5 minutes; Other: Listening to music for 20 minutes

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The control group will be seated for 20 minutes without doing anything else, and not listen to music.	Other: 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.
Experimental: 1 minute music group; The 1 minute music group will be seated for 19 minutes without doing anything else, and listen to music for 1 minute.	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).
Experimental: 5 minutes music group; The 5 minutes music group will be seated for 15 minutes without doing anything else, and listen to music for 5 minutes.	Other: 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).
Experimental: 20 minutes music group; The 20 minutes music group will listen to music for 20 minutes.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Markus Klimek, MD PhD, Erasmus Medical Center

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Music-induced analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: NL82922.078.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be shared upon request. This decision will be made by the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No