| CTRI Number |
CTRI/2025/07/090860 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Audio distraction therapies during extraction procedures in children |
|
Scientific Title of Study
|
Comparative evaluation of different audio distraction therapies during extraction procedures in children- A Randomised Controlled 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 |
Akansha Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
5th floor, Department of Pediatric and Preventive Dentistry, Maulana
Azad Institute of Dental Sciences, BSZ Marg, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9582418066 |
| Fax |
|
| Email |
guptaakansha.8105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mridula Goswami |
| Designation |
Professor(SAG) and Head of Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Maulana
Azad Institute of Dental Sciences, BSZ Marg, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9654700977 |
| Fax |
|
| Email |
mm_goswami@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Akansha Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
5th floor, Department of Pediatric and Preventive Dentistry, Maulana
Azad Institute of Dental Sciences, BSZ Marg, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9582418066 |
| Fax |
|
| Email |
guptaakansha.8105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
Not applicable |
| Type of Sponsor |
Other [Self] |
|
|
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 Akansha Gupta |
Maulana Azad Institute Of Dental Sciences |
Post Graduate clinic,
5th floor, Department of
Pediatric and
Preventive Dentistry
Central
DELHI |
9582418066
guptaakansha.8105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music with vocals on headphones |
Use of music with vocals on headphones as audio distraction method in children undergoing extraction (6 months). |
| Intervention |
Music with vocals on speaker |
Use of music with vocals on speaker as audio distraction method in children undergoing extraction (6 months). |
| Intervention |
Music without vocals on headphones |
Use of music without vocals on headphones as audio distraction method in children undergoing extraction (6 months). |
| Intervention |
Music without vocals on speaker |
Use of music without vocals on speaker as audio distraction method in children undergoing extraction (6 months). |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the age group of 6 to 10 years.
2. Children having primary teeth indicated for extraction.
|
|
| ExclusionCriteria |
| Details |
1. Children with any Special Health Care needs or systemic disease.
2. Children with any physical disabilities.
3. Children allergic to local anaesthesia.
4. Children with history of any previous dental extraction.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Satisfactory effectiveness of music as an audio distraction therapy during simple extraction procedures in children. |
Preoperative, during local anaesthesia administration and during extraction procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better effectiveness of music with vocals than without vocals during simple extraction procedures in children. |
Preoperative, during local anaesthesia administration and during extraction procedure. |
| Better effectiveness of music with headphones than speaker during simple extraction procedures in children. |
Preoperative, during local anaesthesia administration and during extraction procedure. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/07/2025 |
| Date of Study Completion (India) |
30/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a randomized, single-blinded, single-centre trial comparing the effectiveness of four
types of audio distraction therapies/techniques during simple extraction
procedures in children in the age group of 6-10 years in the Department of Pediatric and
Preventive Dentistry, MAIDS. The primary outcome will depict the satisfactory effectiveness of music as an
audio distraction therapy during simple extraction procedures in children. It will be evaluated at three points, ie., preoperatively, during LA administration and during extraction procedure. The need for this study arises from the lack of comprehensive data comparing these types of audio distraction therapies.
|