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Completed

NCT Number: NCT06286137

Duration of Music Interventions and Pain Tolerance (DOMINANT)

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

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Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Listening to music for 1 minute

Other

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

Other

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

Other

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

Other

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.

Primary outcomes

  1. Pain tolerance

    Time frame: 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.

    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.

Secondary outcomes

  1. Heart rate variability (HRV)

    Time frame: 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.

    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).

  2. Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire

    Time frame: At baseline and immediately after the intervention, after the electric 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 a higher score indicating a higher level of anxiety.

  3. Valence and arousal, Self-Assessment manikin (SAM) questionnaire

    Time frame: At baseline and immediately after the intervention, after the electric 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.

  4. Music listening Questionnaire

    Time frame: At baseline. Measured at the same day as the experiment.

    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.

  5. Pain intensity

    Time frame: At the end of the intervention, immediately after each electric stimulus. 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.

  6. Pain unpleasantness

    Time frame: At the end of the intervention, immediately after each electric stimulus. 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: DOMINANT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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