Clinical trial NCT06286137: Duration of Music Interventions and Pain Tolerance (DOMINANT)
Official title: Duration of Music Interventions and PAiN Tolerance in Healthy Individuals: the DOMINANT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: Music-induced analgesia
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain tolerance
timeFrame: 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 outcomes:
measure: Heart rate variability (HRV)
timeFrame: 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.
measure: Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire
timeFrame: At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.
measure: Valence and arousal, Self-Assessment manikin (SAM) questionnaire
timeFrame: At baseline and immediately after the intervention, after the electric stimuli. Measured at the same day as the experiment.
measure: Music listening Questionnaire
timeFrame: At baseline. Measured at the same day as the experiment.
measure: Pain intensity
timeFrame: At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.
measure: Pain unpleasantness
timeFrame: At the end of the intervention, immediately after each electric stimulus. Measured at the same day as the experiment.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Markus Klimek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666.
citation: 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.
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.
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.
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.
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.