Evaluation of the Sedative Effect of Music Listening on Pain Induced by a Thermal Stimulus (Cold Pressor Test)
Phase: NA
Conditions: Analgesic Effects of Music
Sponsor: Rawane El Dimachki

 
 
 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
 
Sedative Effect of Music Listening on Pain Induced by a Thermal Stimulus (Cold Pressor Test) 
 
 
 
 
 
 
 
14/11/2025 
 
 

Protocol 2: Sedative Effect of Music Listening on Pain Induced by a Thermal Stimulus 
(Cold Pressor Test) 
This study aims to evaluate the sedative effect of music listening on pain induced by a thermal 
stimulus (cold pressor test) in a significant sample of healthy young adults (n = 40), by examining 
the musicological components likely to induce analgesic and anxiolytic sedation. 
I- 
Objectives 
The main objective of this research is to evaluate the sedative effect of music listening on 
participants’ pain and anxiety during the cold pressor test, in order to justify the musical choices 
used in Protocol 3. This evaluation considers two essential components: cultural contextualization 
and personal contextualization of the music listening experience. 
Specific Objectives 
 
To evaluate the sedative effect of music listening based on transcultural criteria of melodic 
structure 
and 
tempo: 
This approach aims to determine whether musical sequences selected according to 
universal musical structures (such as modal scale, intervallic structure, and tempo) can 
induce analgesic and anxiolytic effects, independently of cultural specificities and 
individual preferences.  
 
To analyze the impact of rhythmic stylistic parameters according to cultural 
contextualization: 
This objective aims to examine whether musical sequences with rhythmic structures 
aligned with the participant’s cultural musical traditions (particularly Mašriq rhythmic 
styles) can influence pain and anxiety perception, independently of universal factors and 
personal preferences.  
 
To 
evaluate 
the 
influence 
of 
the 
participant’s 
psychomusical 
profile: 
The objective is to understand whether music selected according to individual preferences 
(listening habits and musical tastes) induces an analgesic and anxiolytic sedative effect, 
independently of universal and cultural musicological criteria.  
 
To 
determine 
the 
multifactorial 
effect 
of 
music 
listening: 
This objective examines whether the sedative effect of music results from a combination 
of cultural factors (related to musical type) and personal factors (based on individual 
preferences), and how this interaction may produce an overall therapeutic effect during the 
cold pressor test.  
These objectives aim to deepen the understanding of the musicological and neurocognitive 
mechanisms underlying the sedative effect of music in healthcare settings and to propose a more 
precise musical modeling adapted to therapeutic needs in dental care. 
 

II- 
Theoretical Framework and Justification of the Cold Pressor Test 
In this study, the cold pressor test is used as an experimental method to induce controlled and 
quantifiable pain in healthy participants, allowing the observation of the sedative effect of music 
listening on pain perception. 
This test consists of immersing one hand in cold water, typically maintained between 0 and 5°C, 
until a tolerable pain threshold is reached. This type of thermal stimulus, known for producing 
stable and reproducible pain, provides a valuable experimental model for evaluating therapeutic 
interventions such as the analgesic effects of music. 
The cold pressor test is widely used in psychology and neuroscience research to assess pain 
responses and to study how interventions (such as meditation, hypnosis, or music listening) 
modulate pain perception. Previous studies have shown that it activates nociceptive systems and 
triggers physiological stress responses, making it an ideal model to examine cognitive regulation 
of pain and stress-reduction interventions. 
 
III- 
Population 
The study will involve 40 students from Antonine University, aged 18 to 35 years, recruited 
according to predefined inclusion and exclusion criteria. Participation is voluntary, and all 
participants will sign an informed consent form prior to the study. 
Exclusion Criteria 
 
Acute or chronic pain  
 
History of cardiovascular disorders  
 
Use of analgesic medication  
 
Recent wound on either hand  
 
History of hand fracture  
 
Dermatological condition affecting the hand  
 
History of frostbite  
 
Use of neuropsychiatric medication  
 
Ability to keep the hand immersed for 4 minutes during the silence phase  
 
IV- 
Data Handling and Confidentiality 
All collected data will be treated confidentially and anonymized. Physiological and 
psychophysiological data will be recorded and analyzed strictly for scientific purposes. Each 
participant will be assigned a code to ensure anonymity. Results will be published only in 
aggregated form without individual identification. 
 

V- 
Procedure 
Before the procedure, participants will complete a questionnaire collecting personal information 
such as age and nationality (to assess cultural influence), as well as psychomusical history, musical 
expertise, and musical preferences. They will also sign an informed consent form. 
Participants will be exposed to pain induced by a thermal stimulus by immersing their hand in a 
container of ice water maintained at 5°C. 
Each participant will undergo a session consisting of seven distinct cold pressor phases, each 
lasting up to 4 minutes, separated by 15-minute intervals. 
Between phases, participants will have access to warm water to restore normal hand temperature 
and reduce pain sensation. 
Participants will alternate hands between phases to minimize adaptation or increased tolerance in 
a single hand. 
Participants may withdraw their hand at any time if the sensation becomes intolerable. 
 
Experimental Phases 
 
Phase 1: Silence  
 
Phase 2: Instrumental music with pleasant emotional valence and measured rhythm  
 
Phase 3: Instrumental music with unpleasant emotional valence and measured rhythm  
 
Phase 4: Instrumental music with pleasant emotional valence and non-measured rhythm  
 
Phase 5: Instrumental music with unpleasant emotional valence and non-measured rhythm  
 
Phase 6: Participant-selected music from a predefined set of relaxing musical sequences  
 
Phase 7: Silence (to assess potential habituation effects) 
 
Phase 8: (optional): Participant’s own preferred music 
VI- 
Outcome Measures 
 Pain Intensity : Measured using a Visual Analog Scale (VAS) before, during, and after 
each phase. 
 Reaction Time : The time taken for participants to perceive pain will be recorded. 
 Pain Tolerance Duration : The duration of hand immersion will be measured using a 
stopwatch. 
 Qualitative Feedback : Participants will provide qualitative feedback on their experience, 
offering deeper insight into subjective perceptions of music’s effect on pain. 
 

VII- Materials 
 
Plastic containers (28 × 19 × 10 cm)  
 
Water  
 
Ice packs (10 × 1 kg)  
 
Water thermometer  
 
Pulse oximeter  
 
Stopwatch  
 
Visual analog scale  
 
Questionnaires for qualitative feedback  
 
Musical sequences 
 
VIII- Statistical Analysis Plan (SAP) 
 
This Statistical Analysis Plan (SAP) specifies the statistical methods and procedures that will be 
used to analyze the data collected in this experimental within-subject study evaluating the 
analgesic and anxiolytic effects of music listening during a cold pressor test. 
The study follows a repeated-measures design in which each participant undergoes multiple 
experimental conditions (silence and different musical conditions), allowing intra-individual 
comparisons. 
 
 Study Design Overview 
 
Design: Within-subject repeated measures experimental design  
 
Sample size: n = 40 healthy adults  
 
Conditions (within-subject factor):  
o Silence (baseline and final control)  
o Structured musical conditions (valence × rhythm)  
o Self-selected music condition(s)  
 
Primary comparison: Differences in pain and anxiety outcomes across experimental 
conditions  
 
 Objectives and Hypotheses 
Primary Objective 
To evaluate whether music listening enhances pain tolerance during the cold pressor test 
compared to silence. 

Primary Hypothesis (H1): 
Music conditions will significantly reduce pain intensity compared to silence. 
Secondary Objectives 
1. Assess the effect of musical structure (valence, rhythm)  
2. Evaluate cultural contextualization effects  
3. Evaluate individual preference effects  
4. Examine interaction effects between musical factors  
 
 Outcome Measures 
Primary Outcome 
 
Pain tolerance: Duration of hand immersion  
Secondary Outcomes 
 
Pain intensity (Visual Analog Scale – VAS)  
 
Reaction time to pain onset  
 
Qualitative feedback (exploratory analysis)  
 
 Data Structure 
 
Within-subject factor: Condition (7–8 levels)  
 
Repeated measures: 
Measurements taken: during 
 
Covariates:  
o Age  
o Musical expertise  
o Music preference  
 
 General Statistical Principles 
 
Significance level (α): 0.05  
 
Two-tailed tests  
 
Software: Python  
 
Data presentation:  
o Mean ± SD for normally distributed variables  
o Median (IQR) for non-normal data  

 Assumption Testing 
Before parametric analyses: 
Normality 
 
Shapiro–Wilk test  
 
Q-Q plots  
 Primary Analysis 
 Effect of music on pain tolerance 
 
Test: Repeated Measures ANOVA  
 
Factor: Condition (within-subject)  
Model: Pain ~ Condition 
Post-hoc comparisons: Bonferroni correction  
 
 Secondary Analyses 
1. Musical Structure Effects 
 
Factors:  
o Valence (pleasant vs unpleasant)  
o Rhythm (measured vs non-measured)  
 
Test: Two-way repeated measures ANOVA  
Model: 
Pain ~ Valence × Rhythm 
2. Individual Preference Effect 
 
Compare:  
o Self-selected music vs imposed music  
 
Test: repeated measures ANOVA  
 
3. Reaction time to pain 
 
If normally distributed → ANOVA  
 
If skewed → non-parametric test (Friedman test)  

 Non-Parametric Analyses  
If assumptions are violated: 
 
Friedman Test (alternative to repeated measures ANOVA)  
 
Wilcoxon Signed-Rank Test (post-hoc comparisons)  
 Exploratory Analyses 
Correlation Analyses 
 
Between:  
o Music preference scores  
o Pain reduction  
 
Test:  
o Pearson (normal data)  
o Spearman (non-normal)