| CTRI Number |
CTRI/2024/01/061679 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Harmonizing Comfort: A Comprehensive Investigation into the Impact of White, Brown, and Pink Noise on Pediatric Dental Anxiety during Extraction Procedures – A Randomized Control Study |
|
Scientific Title of Study
|
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 Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja K Dialani |
| Designation |
Assistant Professor |
| Affiliation |
JMFs ACPM Dental College Dhule 424001. |
| Address |
Department of Pediatric and Preventive Dentistry, JMFs ACPM Dental College, Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
918668811500 |
| Fax |
|
| Email |
pooja99dialani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja K Dialani |
| Designation |
Assistant Professor |
| Affiliation |
JMFs ACPM Dental College Dhule 424001. |
| Address |
Department of Pediatric and Preventive Dentistry, JMFs ACPM Dental College, Dhule
MAHARASHTRA
424001
India |
| Phone |
918668811500 |
| Fax |
|
| Email |
pooja99dialani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja K Dialani |
| Designation |
Assistant Professor |
| Affiliation |
JMFs ACPM Dental College Dhule 424001. |
| Address |
Department of Pediatric and Preventive Dentistry, JMFs ACPM Dental College, Dhule
MAHARASHTRA
424001
India |
| Phone |
918668811500 |
| Fax |
|
| Email |
pooja99dialani@gmail.com |
|
|
Source of Monetary or Material Support
|
| JMFs ACPM Dental College, Dhule - 424001 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja K Dialani |
| Address |
JMFs ACPM Dental College, Dhule |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja K Dialani |
JMFs ACPM Dental College, Dhule |
Department of Pediatric and Preventive Dentistry, Dept. no. 6
Dhule
MAHARASHTRA |
918668811500
pooja99dialani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JMFs ACPM Dental College, Dhule. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brown Noise |
Brown noise is a type of sound that is characterized by a decrease in intensity as frequency increases. Brown noise has a higher intensity at lower frequencies, leading to a deeper, bass-heavy sound. |
| Comparator Agent |
Cartoon music |
Music from various popular cartoon shows is taken as a comparator agent |
| Intervention |
Pink noise |
Pink noise is a type of sound that is characterized by a consistent energy distribution per octave. Pink noise has equal energy in each octave, meaning that as the frequency increases, the power decreases. |
| Intervention |
White noise |
White noise is a type of sound that encompasses all frequencies within the audible range to an equal extent, creating a consistent and uniform background noise. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in dental anxiety after the treatment using different types of Audio distraction. |
After local anesthesia administration and after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
After Local anesthesia administration
After treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/01/2024 |
| Date of Study Completion (India) |
20/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sent for Publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |