Clinical Trial

Music Induced Modulation of Pressure Pain Sensitivity and Affective Valence, Comparing Silence and Self-Selected Levantine Music

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Record status
This record was last updated March 27, 2026 (before its estimated April 5, 2026 completion). Its status may not reflect the trial's current state.
Summary
Pain perception is strongly influenced by emotional state, and music has emerged as a promising non-pharmacological tool for pain modulation through its effects on affective state, attention, and autonomic physiology. Despite growing evidence supporting music-induced analgesia, most studies have focused on Western populations and music genres. Levantine music, rooted in the maqam system-melodic modes with deeply embedded emotional associations- remains largely unexplored in this context. Furthermore, evidence on the effects of music on healthy individuals is limited. Objective: This pilot study aims to examine the effect of self-selected Levantine music on pressure pain threshold (PPT) and affective valence compared to silence in healthy Lebanese university students, and to establish feasibility for a future full-scale randomized controlled trial. Design: Randomized, crossover, counterbalanced pilot study with assessor blinding. Approved by the Antonine University Ethics Committee. Reported following CONSORT guidelines. Participants: 12 healthy Lebanese adults (aged 18-25), divided into 2 groups of 6. Inclusion requires no chronic pain, no hearing impairment, and no current analgesic use. Participants are excluded for neurological, cardiovascular, metabolic, or psychiatric conditions, recent injury at testing sites, or hypertension (\>140/90 mmHg). Procedure: Both groups were assessed at baseline while seated, with PPT, blood pressure, heart rate, and affective valence (SAM) all recorded before any auditory condition began. Participants were then fitted with the Sony WH-1000XM6 noise-cancelling headphones. Group 1 starts with silence, then listens to self-selected Levantine music. Group 2 does the reverse. A 15-minute rest period separates the two conditions to avoid carryover effects. All sessions take place at the same time of day, in a standardized environment, with noise controlled through the same headphones. Outcome Measures: * Primary: PPT, measured using a Wagner FPX 50 digital algometer (kg/cm²) at two sites on the non-dominant side: the upper trapezius and the lateral calf. Pressure is applied at 1 kg/s; the mean of four readings is used. A ≥10% increase in PPT from baseline defines a responder. Meaningful change is evaluated against the Minimal Detectable Change (MDC95). * Primary: NPRS: An 11-point numeric pain rating scale (0 = no pain, 10 = worst possible pain) administered during each PPT measurement. * Secondary: SAM: The Self-Assessment Manikin, a non-verbal pictorial scale measuring emotional valence, arousal, and dominance (Cronbach's α = 0.83), completed at baseline and after each condition. * Secondary: BP \& HR: Blood pressure and heart rate measured via digital sphygmomanometer and oximeter as markers of autonomic cardiovascular response. Statistical Analysis: Descriptive statistics (mean ± SD) will be reported for all outcomes. Primary inferential analysis will use a repeated-measures ANOVA or linear mixed-effects model. Exploratory mediation analysis will assess whether changes in valence and/or arousal mediate the relationship between auditory condition and PPT change. Pilot findings will inform power calculations for the full-scale trial. Hypotheses: Self-selected Levantine music is expected to produce a greater increase in PPT than silence, with positive affective valence and optimal arousal hypothesized as partial mediators of this effect.
Trial Details
NCT Number NCT07496866
Lead Sponsor charbel najem
Conditions Healthy Participants, Healthy Young Adults
Enrollment 32 participants
Start Date 2026-02-12
Primary Completion 2026-04-05 (estimated)
Study Completion 2026-04-24 (estimated)
Updated on ClinicalTrials.gov 2026-03-27