Duration of Music Interventions and Pain Tolerance (DOMINANT)
- Conditions
- Pain, Acute
- Interventions
- Other: Not listening to musicOther: Listening to music for 1 minuteOther: Listening to music for 5 minutesOther: Listening to music for 20 minutes
- Registration Number
- NCT06286137
- Lead Sponsor
- Erasmus Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Not listening to music The control group will be seated for 20 minutes without doing anything else, and not listen to music. 1 minute music group Listening to music for 1 minute The 1 minute music group will be seated for 19 minutes without doing anything else, and listen to music for 1 minute. 5 minutes music group Listening to music for 5 minutes The 5 minutes music group will be seated for 15 minutes without doing anything else, and listen to music for 5 minutes. 20 minutes music group Listening to music for 20 minutes The 20 minutes music group will listen to music for 20 minutes.
- Primary Outcome Measures
Name Time Method Pain tolerance 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 Outcome Measures
Name Time Method Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire 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.
Music listening Questionnaire 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.
Pain intensity 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.
Heart rate variability (HRV) 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).
Valence and arousal, Self-Assessment manikin (SAM) questionnaire 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.
Pain unpleasantness 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.
Trial Locations
- Locations (1)
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands