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临床试验/CTRI/2025/11/097916
CTRI/2025/11/097916尚未招募4 期

EVALUATION OF BINAURAL BEATS, ISOCHRONIC TONES AND WHITE NOISE IN REDUCTION OF DENTAL ANXIETY AND PHYSIOLOGICAL INDICES IN PATIENT REQUIRING ROOT CANAL THERAPY. A RANDOMIZED CONTROLLED TRIAL.

DrShradha Ram Kombade1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
96
试验地点
1

研究概览

简要总结

Title****Evaluation Of Binaural Beats, Isochronic Tones, White Noise Music In Reduction Of Dental Anxiety and physiological indices in patients requiring root canal therapy: A  Randomized Controlled Trial.

Among various dental procedures, endodontic treatment is often regarded as one of the most painful and anxiety-provoking experiences by patients. Studies have shown that a significant portion of the population reports high levels of fear and anxiety related to root canal therapy

Dental procedures are generally associated with discomfort and pain, and many individuals experience apprehension both before and after treatment. Dental anxiety remains one of the major challenges in dental practice, often interfering with effective treatment delivery. Epidemiological studies suggest that approximately 20–30 percentage of individuals experience fear or anxiety prior to dental care.

Severe anxiety can heighten the perception of pain during and after dental procedures, increase the risk of psychological distress or syncope, reduce the frequency of dental visits, and negatively affect the patient’s overall quality of life.

One of the effective non-pharmacological methods for alleviating dental anxiety is music-induced relaxation. Music therapy serves as a supportive approach that can help manage various physical, emotional, and psychological conditions such as pain, anxiety, depression, and communication difficulties.

**Given the limited number of studies exploring binaural beat technology in dental settings and its promising clinical potential,**the present research aims to evaluate the effect of binaural beats on patients’ anxiety levels during and after dental procedures.

Binaural beats are auditory illusions perceived when two tones of slightly different frequencies are presented separately to each ear. The brain interprets these as a single sound with a fluctuating amplitude at a frequency equal to the difference between the two tones.

In contrast, isochronic tones are composed of single, regularly repeating beats of a specific tone. The perceived frequency corresponds to the number of amplitude peaks per second, creating rhythmic auditory stimulation.

Another form of relaxation-based intervention is music therapy using 432 Hz frequency, which is considered by many musicians to be more in harmony with natural human resonance. Music with slow tempo and soothing melody induces emotional calmness and physical relaxation in listeners. This “neutral” type of music minimizes emotional triggers that may otherwise provoke physiological stress responses. According to Steelman, music therapy can lower blood pressure, stabilize heart rhythm irregularities, and promote relaxation during procedures performed under local anesthesia.

This single-center, parallel-group, double blind, randomized control trial was conducted on 96 adult patients requiring root canal therapy. Corah Dental Anxiety Scale was used to assess the baseline anxiety levels of patients along with baseline Systolic (SBP) & Diastolic (DBP) blood pressure along with heart rate (HR). Patients were then divided into 4 groups depending on the sound they will experience, Group 1: Binaural Beats, Group 2: Isochronic tones, Group 3: White noise and Group 4: No Sound.  Anxiety levels and SBP, DBP and HR were again measured at two different intervals, after exposure to the sounds.

Statistical analysis was carried out using One way Anova and Kruskal Wallis test.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy Patients (ASA I or ASA II).
  • Subjects diagnosed with irreversible pulpitis requiring root canal therapy.
  • Subjects requiring root canal therapy with any tooth apart from third molars will be considered.
  • Irreversible pulpitis or necrosis of pulp secondary to dental caries.
  • Subjects giving written informed consent.

排除标准

  • 1.Children below the age of 18 years above 60 yr.
  • 2.Pt on antihistamines, antidepressants, anticholinergics.
  • 3.Medically compromised patient ex.
  • Epileptic , Diabetic, Hpertensive .
  • 4.Patients who have not signed the consent form.
  • 5.Patient not willing to participant in study.

研究者

发起方
DrShradha Ram Kombade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ramchandra Kabir

MIDSR DENTAL COLLEGE LATUR

研究点 (1)

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