| CTRI Number |
CTRI/2025/11/097161 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Diagnostic Preventive Screening Dentistry Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of dental anxiety on local anesthesia with help of music therapy for pain |
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Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANKITA GOTE |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Second floor 6 department of Conservative Dentistry and Endodontics, Swargiya Daadsaheb Kalmegh Smutri Dental College and Hospital Wanadongri, Hingna, Dist. Nagpur, Maharasthra - 441110 INDIA Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital Wanadongri, Hingna, Dist. Nagpur - 441110 Nagpur MAHARASHTRA 441110 India |
| Phone |
7448289891 |
| Fax |
|
| Email |
agotepatil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR AMBAR RAUT |
| Designation |
Head of DepartmentT |
| Affiliation |
Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Second floor 6 department of Conservative Dentistry and Endodontics, Swargiya Daadsaheb Kalmegh Smutri Dental College and Hospital Wanadongri, Hingna, Dist. Nagpur, Maharasthra - 441110 INDIA Swargiya Daadsaheb Kalmegh Smruti Dental College And Hospital Wanadongri, Hingna, Dist. Nagpur – 441110 Nagpur MAHARASHTRA 441110 India |
| Phone |
8237652653 |
| Fax |
|
| Email |
ambarraut@sdkdentalcollegeedu.in |
|
Details of Contact Person Public Query
|
| Name |
DR AMBAR RAUT |
| Designation |
Head of DepartmentT |
| Affiliation |
Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Second floor 6 department of Conservative Dentistry and Endodontics, Swargiya Daadsaheb Kalmegh Smutri Dental College and Hospital Wanadongri, Hingna, Dist. Nagpur, Maharasthra - 441110 INDIA Swargiya Daadsaheb Kalmegh Smruti Dental College And Hospital Wanadongri, Hingna, Dist. Nagpur – 441110 Nagpur MAHARASHTRA 441110 India |
| Phone |
8237652653 |
| Fax |
|
| Email |
ambarraut@sdkdentalcollegeedu.in |
|
|
Source of Monetary or Material Support
|
| Wireless Bluetooth headphones from OnePlus company INDIA 441110 |
|
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Primary Sponsor
|
| Name |
Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Waddhamna wanadongari hingna nagpur 441110 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANKITA GOTE |
Swargiya Daadsaheb Kalmegh Smruti Dental College and Hospital |
Second floor 6 department of Conservative Dentistry and Endodontics, Swargiya Daadsaheb Kalmegh Smutri Dental College and Hospital Wanadongri, Hingna, Dist. Nagpur, Maharasthra - 441110 INDIA
Nagpur MAHARASHTRA |
7448289891
agotepatil@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDKS Dental College Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Carious Teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of local anesthesia with music therapy |
Patient will be given music therapy that is the relaxing music of flute and water of 432 Hz for 30 mins through one plus wireless headphones after that Inferior alveolar nerve block [1.8ml,1:200000 adrenaline] will be given to the patients. Action of LA on soft tissue and hard tissue will examine and rating will be given as failed, difficult, successful. After that to assess the procedural pain [during administration of LA]. Patient will be again asked to give rating on Visual analogue scale that how painful was the experience/procedure for them with music therapy. The further treatment will be completed. |
| Comparator Agent |
Local anaesthesia [1:200000 adrenaline] |
Inferior alveolar nerve block [1.8ml,1:200000 adrenaline] will be given to the patients.
Action of LA on soft tissue and hard tissue will be examined and rating will be given as failed, difficult, successful.
After that to assess the procedural pain [during administration of LA]. Patient will be again asked to give rating on Visual analogue scale that how painful was the experience/procedure for them.
The further treatment will be completed
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients
Age 18-50 years
Patients who needs of restorative/endodontics treatment with LA
|
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases
Mentally retarded patients
Patients allergic to LA
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Action of local Anesthesia will be evaluated, Dental anxiety levels will be evaluated and Procedural pain will be evaluated |
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
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Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="8" Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
| 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. | |