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临床试验/NCT07543042
NCT07543042已完成不适用

Musical Grammatological and Neurocognitive Parameterization of Analgesic and Anxiolytic Effects of Culturally and Personally Contextualized Music Listening During Painful Dental Procedures

Rawane El Dimachki1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Perceived Pain Intensity

研究概览

简要总结

The goal of this clinical study is to determine whether listening to culturally and personally contextualized music can reduce pain and anxiety in adults undergoing dental procedures. It will also examine how this intervention affects physiological responses related to stress.

The main questions it aims to answer are:

  • Does listening to a preselected, patient-chosen musical sequence reduce perceived pain during a dental procedure?
  • Does the music modulate physiological stress responses, such as heart rate and blood pressure?
  • Do the analgesic and anxiolytic effects vary depending on the patient's cultural musical preferences (e.g., Mashriq vs. Western music)? How do patients perceive the effectiveness of the music, and how does this relate to physiological and self-reported measures?

Researchers will compare periods with and without music during the same dental procedure to evaluate the effect of the musical intervention.

Participants will:

  • Choose a musical sequence from a predefined selection based on relaxing musical characteristics
  • Undergo a dental treatment involving drilling for caries
  • Experience alternating phases with and without music during the procedure
  • Have their heart rate, blood pressure, and pain levels measured at different stages
  • Complete questionnaires assessing anxiety before the procedure and their experience after the treatment

The study includes 30 adult participants and is conducted in a private dental clinic.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18 to 60 years.
  • Visiting the dental clinic for treatment of dental caries.
  • Able to provide written informed consent.

排除标准

  • Patients who do not provide written informed consent.
  • Children (under 18 years of age).
  • Patients with known mental or physical disorders.
  • Pregnant women.
  • Patients currently taking analgesics, anxiolytics, or antidepressants.

研究组 & 干预措施

Music Listening During Dental Procedure (Within-Subject Design)

Experimental

All participants are exposed to both control (no music) and intervention (music listening) conditions within the same dental procedure. After baseline measurements, participants undergo a standardized dental drilling sequence divided into phases: a control phase without music, an intervention phase during which they listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist, and a post-intervention control phase without music.

干预措施: Baseline Assessment (T0) (Behavioral)

Music Listening During Dental Procedure (Within-Subject Design)

Experimental

All participants are exposed to both control (no music) and intervention (music listening) conditions within the same dental procedure. After baseline measurements, participants undergo a standardized dental drilling sequence divided into phases: a control phase without music, an intervention phase during which they listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist, and a post-intervention control phase without music.

干预措施: Control Condition - Silence (Pre-Music Phase) (Behavioral)

Music Listening During Dental Procedure (Within-Subject Design)

Experimental

All participants are exposed to both control (no music) and intervention (music listening) conditions within the same dental procedure. After baseline measurements, participants undergo a standardized dental drilling sequence divided into phases: a control phase without music, an intervention phase during which they listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist, and a post-intervention control phase without music.

干预措施: Music Listening Condition (Intervention Phase) (Behavioral)

Music Listening During Dental Procedure (Within-Subject Design)

Experimental

All participants are exposed to both control (no music) and intervention (music listening) conditions within the same dental procedure. After baseline measurements, participants undergo a standardized dental drilling sequence divided into phases: a control phase without music, an intervention phase during which they listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist, and a post-intervention control phase without music.

干预措施: Control Condition - Silence (Post-Music Phase) (Behavioral)

结局指标

主要结局

Perceived Pain Intensity

时间窗: At T0 (before the procedure), at T1 (30seconds after initiation of drilling, pre-music), at T2 (150seconds after initiation of the procedure,during music), at T3 (330seconds after initiation of the procedure,post-music) within a single treatment session.

Participants report their pain level during each phase of the dental drilling procedure using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).

次要结局

  • Heart Rate(Baseline (before the procedure), T1 (30 seconds after initiation of drilling, pre-music), T2 (150 seconds after initiation of the procedure, during music), T3 (330 seconds after initiation of the procedure, after music) within a single treatment session.)
  • Blood Pressure (Systolic and Diastolic)(Baseline (before the procedure), T1 (30 seconds after initiation of drilling, pre-music), T2 (150 seconds after initiation of the procedure, during music), T3 (330 seconds after initiation of the procedure, after music) within a single treatment session.)
  • Post-Treatment Perception of Music Effectiveness(Measured immediately after the dental procedure (post-treatment).)

研究者

发起方
Rawane El Dimachki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rawane El Dimachki

Chairperson of the department of music therapy

Antonine University

研究点 (1)

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