Musical Grammatological and Neurocognitive Parameterization of Analgesic and Anxiolytic Effects of Culturally and Personally Contextualized Music Listening During Painful Dental Procedures
Phase: NA
Conditions: Dental Pain, Dental Anxiety
Sponsor: Rawane El Dimachki

 
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
Musical Grammatological and Neurocognitive Parameterization of Analgesic and Anxiolytic 
Effects of Culturally and Personally Contextualized Music Listening During Painful Dental 
Procedures 
 
 
 
 
 
 
16/07/2025 
 
 
 
 
 
 
 
 
 

Musical Grammatological and Neurocognitive Parameterization of Analgesic and Anxiolytic 
Effects of Culturally and Personally Contextualized Music Listening During Painful Dental 
Procedures  
I-Objective 
This study aims to verify, with a significant sample of 30 Lebanese adults, the hypothesis that 
listening to a personally and culturally contextualized musical sequence during a painful dental 
procedure induces a significant decrease in perceived pain and patient anxiety. The music is chosen 
by the patient from a pre-established selection of tracks based on grammatological criteria 
recognized for their analgesic potential. The study also seeks to observe favorable modulation of 
physiological parameters related to stress. 
II- Research Questions  
• 
Can listening to a musical statement chosen from a pre-selected palette based on soothing 
musical grammatological criteria induce an analgesic effect in patients undergoing painful 
dental care?  
• 
Would this musical statement have a modulating effect on the activity of the autonomic 
nervous system, particularly by inhibiting physiological responses associated with stress?  
• 
Do the analgesic and anxiolytic effects of the musical sequence vary according to implicit 
cultural preferences (e.g., Mashriq musical tradition vs. Western music) expressed in the 
patient's choice?  
• 
Are the musical sequences chosen freely by patients from a pre-established palette 
perceived as effective in mitigating pain and anxiety, and to what extent is this perception 
correlated with physiological data and self-assessments?  
III- Musical Material  
The patient is invited to choose a musical sequence from a palette of tracks from various musical 
genres, pre-selected for their relaxing and soothing musical grammatological criteria:  
• 
Samā’ī in Rāst mode – Ghassan Sahhab  
• 
Taḥmīlat Rāst – Album Waṣalāt – Nidaa Abou Mrad and the Antonine University Classical 
Arabic Music Ensemble  
• 
Bašraf Rāst – Album Waṣalāt – Nidaa Abou Mrad and the Antonine University Classical 
Arabic Music Ensemble  
• 
Bašraf Rāst – Album Mikhaîl Mashâqa – Nidaa Abou Mrad and the Antonine University 
Classical Arabic Music Ensemble  
• 
Taqsīm in Rāst mode – Ghassan Sahhab  
• 
"In a Sentimental Mood" in D Major – Duke Ellington  
• 
Nocturne Op.9 No.2 in Eb Major – Chopin  
• 
Cello Suite No. 1 in G Major, BWV 1007: I. Prélude in C Major – Bach  

• 
Sonata for Two Pianos K.448: II. Andante in D Major – Mozart  
• 
Clair de Lune in Db Major – Debussy  
 
IV- Type of Dental Procedure Studied  
The experimental situation selected for this study is dental drilling during cavity treatment, 
performed without local anesthesia or in conditions where pharmacological analgesia is partially 
or totally ineffective. 
• 
Stimulus: Dental drilling constitutes a continuous painful stimulus associated with the 
activation of pain responses and the autonomic nervous system. 
• 
Scientific Model: It represents a relevant model for studying central mechanisms of pain 
modulation (Melzack & Wall, 1965b; Tracey & Mantyh, 2007). 
• 
Clinical Relevance: While local anesthesia is standard, it can be ineffective during acute 
pulp inflammation, in patients with hypersensitivity/intolerance to anesthetics, or due to 
complex nerve anatomy (Hargreaves & Keiser, 2002; Meechan, 2005). 
• 
Patient Preference: Some patients prefer to tolerate the pain of drilling rather than 
experience the prolonged jaw numbness associated with local injections. 
• 
Alternative: In these situations, functional music therapy serves as a pertinent non-drug 
analgesic alternative. Music is a non-invasive intervention that can modulate perceived 
pain, anxiety, and autonomic activation through attentional, emotional, and autonomous 
mechanisms (Bradt et al., 2013; Roy et al., 2008). 
V- Methodology  
The study was conducted from October 1, 2025, to December 23, 2025, in a private dental clinic 
in Aley, Mount Lebanon, following ethical approval from Antonine University on July 16, 2025. 
V-1- Population  
• 
Inclusion Criteria: Adult patients (ages 18–60) visiting the clinic for cavity treatment who 
provide informed consent. 
• 
Exclusion Criteria: Non-consenting patients, children, patients with mental or physical 
disorders, pregnant women, and patients taking analgesics, anxiolytics, or antidepressants. 
V-2- Study Procedure  
1. Welcome: The patient is welcomed in a calm atmosphere and the procedure is explained. 
2. Assessment: The patient completes a general information questionnaire and the Corah 
Dental Anxiety Scale (DAS). 

3. Consent & Selection: The patient signs the informed consent form, chooses their musical 
sequence, and adjusts the volume. 
On the dental chair : 
4. Baseline (Phase 0): Heart rate (HR) and blood pressure (BP) are measured at rest (T0). 
5. Control 1 (Phase 1): 30 seconds of drilling without music. Measurements: HR, BP, and 
Pain Intensity (PI) via Visual Analog Scale (T1). 
6. Pause/rest (120s) + beginning of the music listening 
7. Test (Phase 2): 30 seconds of drilling during music playback. Measurements: HR, BP, 
and PI (T2). 
8. End of the music listening - Pause/rest (120s)  
9. Control 2 (Phase 3): 30 seconds of drilling. Measurements: HR, BP, and PI (T3). 
10. Completion: The patient completes a post-treatment evaluation questionnaire. Note: The 
study takes place at the start of the clinical visit; dental treatment continues normally after 
the final study measurements are taken. 
VI- Statistical Analysis Plan (SAP) 
 
VI-1 Study Design 
• 
Type: Single-arm, within-subject experimental study.  
• 
Participants: 30 adults undergoing dental treatment for caries.  
• 
Phases: Baseline (T0), Phase 1 (pre-music silence), Phase 2 (music), Phase 3 (post-music 
silence).  
• 
Each participant serves as their own control.  
VI-2- Data Collection: Pain measured via Visual Analog Scale (VAS); heart rate (HR) and 
systolic/diastolic blood pressure (BP) recorded at all phases.  
 
VI-3- Statistical Methods 
Primary Outcome – Pain (VAS) 
• 
Analysis:  
o Compare pain levels across phases using repeated measures ANOVA (or Friedman 
test if data violate normality).  
o Post-hoc pairwise comparisons between phases (Phase 1 vs Phase 2, Phase 2 vs 
Phase 3) using Bonferroni adjustment to correct for multiple testing.  
• 
Assumptions:  
o Normality of residuals checked with Shapiro-Wilk test.  
o Sphericity checked with Mauchly’s test; Greenhouse-Geisser correction applied if 
violated.  
Secondary Outcomes 

- 
Physiological Parameters (HR, BP) 
• 
Analysis:  
o Repeated measures ANOVA for HR, systolic BP, and diastolic BP across the four 
phases.  
o Pairwise comparisons with Bonferroni correction.  
• 
Assumptions: Same as primary outcome; log transformation applied if data are skewed.  
- 
Post-Treatment Perception of Music Effectiveness 
• 
Analysis:  
o Frequency distributions and descriptive statistics.  
o Association with pain reduction and physiological changes assessed using 
Spearman correlation.  
VI-4- Software 
• 
Statistical analyses will be performed using Python. 
 
Bibliography 
 
Bradt, J., Dileo, C., & Potvin, N. (2013). Music for stress and anxiety reduction in coronary heart 
disease patients. The Cochrane Database of Systematic Reviews, 2013(12), CD006577. 
https://doi.org/10.1002/14651858.CD006577.pub3 
 
Hargreaves, K. M., & Keiser, K. (2002). Local anesthetic failure in endodontics: Mechanisms and 
Management. Endodontic Topics, 1(1), 26–39. https://doi.org/10.1034/j.1601-1546.2002.10103.x 
 
Meechan, J. G. (2005). Why does local anaesthesia not work everytime? Dental Update, 32(2), 
66–68, 70 72. https://doi.org/10.12968/denu.2005.32.2.66 
 
Melzack, R., & Wall, P. D. (1965). Pain mechanisms: A new theory. Science (New York, N.Y.), 
150(3699), 971–979. https://doi.org/10.1126/science.150.3699.971 
 
Roy, M., Peretz, I., & Rainville, P. (2008b). Emotional valence contributes to music-induced 
analgesia. Pain, 134(1–2), 140–147. https://doi.org/10.1016/j.pain.2007.04.003 
 
Tracey, I., & Mantyh, P. W. (2007). The cerebral signature for pain perception and its modulation. 
Neuron, 55(3), 377–391. https://doi.org/10.1016/j.neuron.2007.07.012