| CTRI Number |
CTRI/2025/05/086410 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of Tickle Teddy Technique and Melodic Mouth Magic on Pain and Anxiety in Children Receiving Local Anesthesia |
|
Scientific Title of Study
|
Effect of mouth organ therapy and vibration therapy on pain perception and anxiety levels in children receiving local anesthesia - A Randomised controllled 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 |
PRAGATI PAREEK |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Pediatric and Preventive Dentistry , 5th floor , Saveetha Dental Collge , Poonamallee , chennai , Tamil Nadu
Chennai
TAMIL NADU
600056
India |
| Phone |
9462779309 |
| Fax |
|
| Email |
152311005.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja VR |
| Designation |
SENIOR LECTURER |
| Affiliation |
SAVEETHA DENTAL COLLEGE |
| Address |
Department of Pediatric and Preventive Dentistry , 5th floor , Saveetha Dental Collge , Poonamallee , chennai , Tamil Nadu
Chennai
TAMIL NADU
600056
India |
| Phone |
8940844133 |
| Fax |
|
| Email |
poojvr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja VR |
| Designation |
SENIOR LECTURER |
| Affiliation |
SAVEETHA DENTAL COLLEGE |
| Address |
Department of Pediatric and Preventive Dentistry , 5th floor , Saveetha Dental Collge , Poonamallee , chennai , Tamil Nadu
Chennai
TAMIL NADU
600056
India |
| Phone |
8940844133 |
| Fax |
|
| Email |
poojvr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals 162 , Poonamallee High Road , Chennai , 600077 India |
|
|
Primary Sponsor
|
| Name |
Pragati Pareek |
| Address |
162, Saveetha Dental College , Poonamallee High Road , Chennai 600077 |
| 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 |
| DRPOOJA VR |
Saveetha Dental College |
Department of Pediatric and Preventive Dentistry , 5th floor , Saveetha Dental Collge , Poonamallee , chennai , Tamil Nadu
Chennai
TAMIL NADU |
8940844133
poojavr.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental college -Institutional Human Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Routine Local Anesthesia administration without distraction |
| Intervention |
Melodic Mouth Magic |
It is a music distraction with headphone and rhytmic humming during LA. |
| Intervention |
Tickle Teddy Technique |
Vibratory distraction device applied to the site during LA administration |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA I to IV status (Healthy)
Requires local anaesthesia for dental treatment
Frankl behaviour Rating 3 or 4
Parents willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Systemic illness or behaviour/developmental disorders
allergic to local anesthetic
previous dental injection experience
frankl rating 1 or 2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain perception using Wong Baker FACES Scale |
Pain perception using Wong Baker FACES Scale at BASELINE- Pretreatment - Posttreatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety levels (Facial Image Scale and heart rate ) |
Before, during , and after LA adminstration |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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="6"
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 randomized controlled clinical trial aims to evaluate the effectiveness of two behavioral distraction techniques—Tickle Teddy Technique (a vibratory device) and Melodic Mouth Magic (music distraction with rhythmic humming)—on pain perception and anxiety levels in children aged 4 to 10 years receiving local anesthesia for dental procedures. A total of 90 healthy children meeting specific inclusion criteria will be randomly assigned to one of three groups: Tickle Teddy, Melodic Mouth Magic, or a control group receiving routine local anesthesia without distraction. Pain will be assessed immediately after anesthesia administration using the Wong-Baker FACES Pain Scale, while anxiety will be measured before, during, and after the procedure using the Facial Image Scale and heart rate monitoring. The study is single-blinded, with the outcome assessor blinded to group allocation, and will be conducted over a period of six months at a single site in India. |