Clinical Research Directory
Browse clinical research sites, groups, and studies.
Music Induced Modulation of Pressure Pain Sensitivity and Affective Valence, Comparing Silence and Self-Selected Levantine Music
Sponsor: charbel najem
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.
Key Details
Gender
All
Age Range
18 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-02-12
Completion Date
2026-04-24
Last Updated
2026-03-27
Healthy Volunteers
Yes
Conditions
Interventions
Music intervention
Both groups were assessed at baseline; the participant was seated and only standard formal interaction occurred. The participant was then fitted with Sony headphones. A 15-minute rest interval was implemented between sessions to minimize potential carryover effects (Becker et al., 2024). If participants were allocated to Group 1, they were first exposed to the silence condition followed by the self-selected Levantine music. If allocated to Group 2, they were exposed to the Levantine music condition first, followed by the silence condition. This sequence was implemented to examine whether the order of conditions had a significant effect on pain
Locations (1)
Antonine University
Baabda, Baabda, Lebanon