Comparing Noise-Canceling Headphones for Children Ages 6–9

Not yet recruiting

• Conditions: Conduct disorder, childhood-onsettype,

• Registration Number: CTRI/2025/05/086137
• Lead Sponsor: Datta Meghe Institute of Higher Education and Research

Brief Summary

The most common challenge in pediatric dentistry is managing childrenwith fear and dental anxiety.  Dental anxiety (DA) is defined as that itis a state of apprehension, coupled with a sense of losing control, which islinked to a feeling that something dreadful is going to happen concerningdental treatment. The prevalence of dental anxiety in childrenranges between 6 and 42% and is attributed to many factors. Dental treatment frequently involves invasive procedures and the use of sharp, high-speed cutting instruments, often requiring multiple visits. This study aims to compare andevaluate the efficacy of Active Noise Cancellation Headphones with 8D Audio and White Noise forReducing Dental Anxiety in children aged 6-9 years.  The groups are as follows  Group 1: Use of ANC headphones before, during and, afterrestorative procedure. Group 2: Use of ANC headphones with 8D audio before,during and, after restorative procedure. Group 3: Use of ANC headphones with white noise before,during and, after restorative Procedure. The findings of this study will help to evaluate and compare the effectiveness of ANC headphones with 8D audio and white noise in reducing children’s anxietyeffectively during the restorative procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-10
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Pediatric patients within the age group of 6- 9 years 2.
• Pediatric patients with dental anxiety 3.
• Fearful but cooperative pediatric patients 4.
• Pediatric patients with parent’s consent.

Exclusion Criteria

• Pediatric patients below 6 years of age 2.
• Pediatric patients with severe cognitive and developmental disabilities 3.
• Pediatric patients with hearing impairment conditions 4.
• Uncooperative pediatric patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ANC headphones with 8D audio will be able to reduce children’s anxiety effectively during the restorative procedures as compared to white noise	Pre and post-treatment assessment will be done. Overall assessment will be done at the end of 1 year.

Trial Locations

Locations (1)

Sharad Pawar Dental College; 🇮🇳 Wardha, MAHARASHTRA, India

Sharad Pawar Dental College

🇮🇳Wardha, MAHARASHTRA, India

Dr Ashray Nimje

Principal investigator

7506180064

ashraynimje@gmail.com