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临床试验/CTRI/2025/11/097161
CTRI/2025/11/097161尚未招募Phase 3 4

COMPARATIVE EVALUATION OF EFFECT OF DENTAL ANXIETY ON ACTION OF LOCAL ANESTHESIA WITH OR WITHOUT MUSIC THERAPY AND ON PROCEDURAL PAIN-A RANDOMIZED CONTROLLED TRAIL

Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月11日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Evaluation of Action of local Anesthesia will be evaluated, Dental anxiety levels will be evaluated and Procedural pain will be evaluated

研究概览

简要总结

 Dental anxiety is a patients’ response to stress in a dental setting. Medical procedures cause a feeling of fear, inability, as well as anxiety. It can be provoked due to multiple factors, such as previous negative or traumatic experience, sensory triggers such as sights of needles and air-turbine drills, sounds of drilling and screaming, vicarious learning from anxious people, patients’ personality characteristics and their coping strategies. Several studies have reported high dental anxiety levels in approximately 10–20% of participants. Pain perception during the administration of local anesthetics is an essential reason for anxiety, and it may be caused by tissue puncture, pressure and velocity of fluid injection, the temperature of the anesthetic, and operator’s skills. This problem can affect various treatment stages and complicate the situation for patients and dentists. Pain seems to be multifactorial and is influenced by psychological factors such as catastrophizing and anxiety. People with a high score on pain catastrophizing reported more severe pain and anxiety, and they consume more analgesic medication. Anxious patients experience more negative and irrational thoughts related to dental treatment. They usually consider the worst-case scenario in their treatment. Avoiding dental treatment due to dental anxiety is related to more missing and decayed teeth. Poor oral and dental health can lead to dental diseases, which reduces the patients’ quality of life and creates a vicious cycle, where patient’s anxiety level increases and their health level decreases. One of the most important factors in patient satisfaction is pain control techniques. Canakci has stated that Measuring pain is difficult because it has physical and psychological aspects. It is subjective and depends on the patient’s perception. Local anesthesia has enabled the profession to make tremendous therapeutic advances. Patients experience severe pain in case of failed anesthesia, which pre vents many dental treatments, including root canal surgery, periodontal surgery, and tooth extraction. Although dental anesthesia is an essential aspect of treatment for patients, an injection can induce anxiety or fear and maybe a reason for patients to avoid dental treatment. Patients with high levels of anxiety usually exhibit lower pain thresholds, and therefore, there is a decreased anesthesia success rate among these patients, and complementary methods are required in this regard. Notably, dentists’ efforts and motivation to prevent pain in patients play an essential role in keeping them calm and relax25. Dental anxiety can affect a patient’s life. Physiological effects include signs and symptoms of fear and fatigue appears after a dentist’s appointment, whereas cognitive impacts are a set of negative beliefs and thoughts. Behavioral results show itself as eating, lack of oral hygiene, self-treatment, and aggression. Moreover, dental anxiety can have adverse effects on general health due to its association with sleeping disorders. Furthermore, the social interactions and performance of these individuals at the workplace may decrease due to a lack of self-esteem and self-confidence. Medical evidence shows a strong relationship between oral and general health. Systemic diseases have a bidirectional relationship, and there are more than 100 systematic diseases with oral manifestations, such as cardiovascular diseases, stroke, respiratory infections (e.g., aspiration pneumonia), pancreas cancer, diabetes, and nutritional problems. Therefore, it can be stated that the treatment of oral diseases plays a vital role in the general health27,28. Given the importance of successful anesthesia for dental care treatments, recognition, and control of fac tors involved in its effectiveness can help increase the possibility of successful anesthesia.

In individuals with dental fear, postponement of dentist appointments and even avoidance of dentists are seen. It has been emphasized that anxiety can be an obstacle for the actual practice of dentistry and dental surgery and may increase the incidence of oral diseases. In patients with high levels of anxiety prior to surgery, more complications and delayed recovery were reported in the postoperative period. In addition to pharmacological treatments, nonpharmacological psychosedative techniques are used to eliminate anxiety prior to dental surgery. Sound and music have been the subject of many pieces of research and studies with their effects on mood and vital functions. The positive and healing effect of music has been the subject of continuous curiosity from the past to the present and has been used frequently for treatment purposes. Especially Sufis, in Islamic civilization, used music and advocated that music had a healing effect. Today, music therapy is evaluated as an efficient, inexpensive and a safe anxiolytic. Music therapy is suggested to provide relaxation acting on the autonomic nervous system. Music played at a low pitch and slow tempo reduces the ability of the nervous transition which normally regulate emotions that cause discomfort and anxiety, thus affecting the limbic system of the brain, which is the center of emotion and excitement. In the literature, it is reported that the application of music therapy to the patient in the preoperative period will reduce the anxiety and perception of pain, prevent the complications that occur due to anxiety and thus accelerate the recovery.

At present, there is no study which has evaluated the effect of dental anxiety on action of local anaesthesia with music therapy and on procedural pain. In light of above considerations, this study is planned to evaluate the effect of dental anxiety on action of local anaesthesia with music therapy and on procedural pain.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Male and female patients Age 18-50 years Patients who needs of restorative/endodontics treatment with LA.

排除标准

  • Patients with systemic diseases Mentally retarded patients Patients allergic to LA.

结局指标

主要结局

Evaluation of Action of local Anesthesia will be evaluated, Dental anxiety levels will be evaluated and Procedural pain will be evaluated

时间窗: Evaluation of Dental anxiety will be done after 30 minutes of music therapy before administration of Local Anesthesia. | The Procedural pain will be evaluated immediately after injecting local anesthesia. Action of local Anesthesia will be evaluated 15 minutes after administration of Local Anesthesia.

次要结局

  • The action of local anaesthesia will be evaluated using the criteria given by Hadi Esmaeili et al., and procedural pain will be evaluated using the Visual Analogue Scale.(6-8 months)

研究者

发起方
Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR ANKITA GOTE

Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital

研究点 (1)

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