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

NCT07496866 | Active Not Recruiting DMC

• 1 other identifier: AntonineU
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants; Healthy Young Adults

Keywords

Levantine music; Valence; Pain pressure sensitivity; Healthy participants; Experimental trial

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Sensitivity

  PPT was assessed as the primary outcome to quantify participants' sensitivity to mechanical pain. PPT measurements were obtained using a Wagner digital algometer at standardized musculoskeletal sites. Participants were instructed to indicate the point at which applied pressure first became painful, and the force (in kilograms) was recorded. Each site was measured twice, with the mean value used for analysis. PPT was measured under both experimental conditions-silence and self-selected Levantine music-to evaluate the modulatory effects of music on pressure pain sensitivity. Changes in PPT between conditions were used to determine the analgesic or pain-modulating effect of the music intervention, with higher PPT values indicating reduced pain sensitivity. This method is consistent with prior research demonstrating that PPT is a reliable and valid marker of musculoskeletal pain sensitivity.

  Up to 80 minutes of assesing the participants at the 3 interventions

Secondary Outcomes (3)

• Affective Valence

  Up to 80 minutes to test the valence change with the 3 interventions

• Blood Pressure

  During the 3 intervention session (approximately 80 minutes)

• Heart Rate

  Up to 80 minutes during the 3 intervention conditions

Study Arms (2)

Group one: Baseline , Silenced, Levantine Music

OTHER

First 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). They will then be first exposed to the silence condition followed by the self-selected Levantine music.

Other: Music intervention

Group Two: Baseline, Levantine Music, Silenced

EXPERIMENTAL

First 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). They were then first exposed to the self-selected Levantine Music condition followed by the silenced condition.

Other: Music intervention

Interventions

Music intervention OTHER

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

Group Two: Baseline, Levantine Music, Silenced; Group one: Baseline , Silenced, Levantine Music

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Lebanese adults aged 18 to 25 years
• No chronic pain
• No hearing impairment
• No current use of analgesic medication

You may not qualify if:

• Neurological disorders
• Recent injury at PPT assessment sites
• Regular use of medication
• Pregnancy
• Severe allergic reactions
• Systemic disease
• Neurological disease
• Metabolic disease
• Cardiovascular disease
• Chronic pain
• Ongoing psychiatric or psychological treatment
• Hypertension (\>140/90 mmHg)

Sponsors & Collaborators

• charbel najem: lead

Study Sites (1)

Antonine University

Baabda, Baabda, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistision
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instuctor and proffesor at the Antonine University

Model Details: This randomized crossover study counterbalanced design study will follow a double blinded, experimental design aimed at examining the modulation of PPT and affective valence induced by two auditory conditions which are silence and self-selected Levantine music

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: February 12, 2026
• Primary Completion: April 5, 2026
• Study Completion: April 24, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)