A Comparative evaluation of the effect of white noise, brown noise and pink noise on dental anxiety of paediatric patients undergoing dental extraction treatment –A Randomised Control Study.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in dental anxiety after the treatment using different types of Audio distraction.
Study Overview
Brief Summary
This research study focuses on addressing the challenges of managing anxiety in pediatric dental patients, emphasizing the preference for non-invasive psychotherapeutic techniques over pharmacological interventions. The study explores the application of audio analgesia, specifically white noise, brown noise, and pink noise, to distract pediatric patients during dental extraction treatments.
The introduction provides a comprehensive background on the management of anxious pediatric patients, highlighting the significance of non-pharmacological techniques in avoiding adverse effects and discomfort associated with drugs. Audio analgesia, introduced in 1959, is discussed as a technique that uses audio means to relieve pain during medical procedures.
The primary question revolves around the potential effects of different frequencies of noises on dental anxiety in pediatric patients aged 8 to 12 years. The primary hypothesis suggests that there is a difference in the effects of white noise, brown noise, and pink noise on dental anxiety during extraction treatment, while the secondary hypothesis questions the presence of such a difference.
The literature review cites a study by Divya Singh et al. (2022) that explored the effects of pink, brown, and white noise on anxious dental patients. The study concluded that audio distraction, regardless of the specific sound shade, was responsible for reducing anxiety.
The aim and objectives of the study are clearly defined, focusing on evaluating and comparing the effects of white, brown, and pink noise on dental anxiety in pediatric patients during extraction treatment. The primary objective includes the evaluation and comparison of the effects on dental anxiety and pain perception.
The methodology outlines a multi-arm, triple-blinded, parallel-group randomized controlled study design. The source of data is the Out Patient Department of the Department of Pediatric & Preventive Dentistry at JMF’s ACPM Dental College, Dhule. Inclusion and exclusion criteria are specified, and the sample size is determined based on a statistical model. The study groups, randomization process, and procedures are detailed, including the use of Venham’s picture scale, pulse rate measurement, and Visual Analogue scale.
The statistical analysis plan includes Mann-Whitney U tests and paired t-tests to compare age, anxiety scores, and post-operative anxiety levels between groups.
In summary, the study aims to contribute to the understanding of the impact of different frequencies of noises on dental anxiety in pediatric patients, utilizing a rigorous research design and comprehensive evaluation methods. The research findings have the potential to inform future non-pharmacological interventions in pediatric dentistry.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 8.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children with Frankl Behavior rating scale of negative (-) and positive (+) Children having their primary tooth indicated for extraction Children who are willing to participate in the study.
Exclusion Criteria
- •Children with special health care needs.
- •Children requiring restorative procedures.
- •Children with deep carious lesions who require pulp therapy.
- •Children who are not willing to participate in the study.
Outcomes
Primary Outcomes
Reduction in dental anxiety after the treatment using different types of Audio distraction.
Time Frame: After local anesthesia administration and after treatment.
Secondary Outcomes
- Comparing the differences in the reduction of dental anxiety and pain using White noise, Brown noise, and Pink noise during the extraction treatment.(Before treatment)
Investigators
Dr Pooja K Dialani
JMFs ACPM Dental College Dhule 424001.