| CTRI Number |
CTRI/2025/09/094045 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using Different Sounds to Help Children Stay Calm and Comfortable During Dental Injections |
|
Scientific Title of Study
|
Assessment of Different Coloured Noises as Non-Pharmacological Distraction Tools in Alleviating Anxiety and Pain during Local Anesthesia in Children: A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganganapalli Reddy Sravya |
| Designation |
MDS 2nd year |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Pediatric and preventive dentistry Room number 7,Division 7,Narayana dental college and hospital, Nellore, Andhrapradesh, India
Pincode :524003
Nellore
ANDHRA PRADESH
524001
India |
| Phone |
07075432819 |
| Fax |
|
| Email |
grsravya98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S.V.S.G Nirmala |
| Designation |
MDS Professor |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Pediatric and preventive dentistry Room number 7,Division 7,Narayana dental college and hospital, Nellore, Andhrapradesh ,India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganganapalli Reddy Sravya |
| Designation |
MDS 2nd year |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Pediatric and Preventive Dentistry, Room number 7, Division 7, Narayana Dental College and Hospital, Nellore
Andhra Pradesh, India
524001
India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
07075432819 |
| Fax |
|
| Email |
grsravya98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and Hospital, Chinthareddypalem Nellore, Andhrapradesh, India
Pincode : 524003 |
|
|
Primary Sponsor
|
| Name |
Ganganapalli Reddy Sravya |
| Address |
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhrapradesh
India
Pincode 524001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ganganapalli Reddy Sravya |
Narayana Dental College and Hospital |
Paediatric and Preventive Dentistry,Division-7,Room number-7
Narayana dental college and hospital, Chinthareddypalem, Nellore
Andhrapradesh
524003
India
Nellore
ANDHRA PRADESH |
07075432819
grsravya98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Dental College and Hospital, Nellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children of age 6-11 years
Children who are indicated for dental procedures under LA
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
There is Comparision among all the three different noises such as White noise, Pink noise and Brown noise. |
This study involves the use of three different coloured noises white, pink, and brown noise as non-pharmacological audio distraction tools during local anesthesia administration in children of age 6-11 years.
Duration : 3 minutes |
| Intervention |
White noise, Pink noise and Brown noise |
Children in Group 1 will listen to white noise through headphones starting 1 to 2 minutes before local anesthesia administration and continuing until the completion of LA administration. Children in Group 2 will listen to pink noise through headphones during the same time period. Children in Group 3 will listen to brown noise through headphones starting 1 to 2 minutes before and continuing until the completion of LA administration.
Total duration:3 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
6-11 years old children
Children who are willing to participate in the study.
Children requiring LA for dental procedures
Children with no cognitive disorders
Children whose parents/guardians provide written informed consent and who provide child assent.
|
|
| ExclusionCriteria |
| Details |
Children with hearing impairments or auditory processing disorders
Those who are not willing to hear noises
Special health care need Children
Recent trauma to oral tissues
Children with systemic illnesses or conditions contraindicating dental treatment.
Children with a history of hypersensitivity reactions to anaesthetic agent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is the reduction in pain and anxiety levels during local anesthesia administration in children, assessed using the Animated Emoji Scale (before and after the procedure), the Sound-Eye-Motor (SEM) Scale (during the procedure), and the Oucher’s Pain Scale (after the procedure). |
Assessments will be carried out at Baseline (before LA administration)
Immediate (during LA administration)
Immediate post-intervention (after LA administration) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will evaluate the effectiveness of auditory distraction using white noise pink noise and brown noise in reducing pain and anxiety during local anesthesia administration in children aged 6 to 11 years. A total of 66 healthy children will be randomly divided into three groups with 22 in each group. Three groups will receive different types of colored noise through headphones . Anxiety will be assessed using the Animated Emoji Scale before and after the procedure. Objective pain will be recorded using the Sound Eye Motor Scale during the procedure and subjective pain will be assessed using the Ouchers Pain Scale after the procedure. Physiological parameters such as pulse rate will be recorded before during and after local anesthesia. Data will be analyzed to compare the effectiveness of different colored noises in reducing pain and anxiety. |