| CTRI Number |
CTRI/2026/03/105214 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can a Weighted Blanket Calm Children’s Dental Anxiety? |
|
Scientific Title of Study
|
Effectiveness of Weighted Blanket–Induced Deep Pressure Stimulation on Dental Anxiety During Local Anaesthesia in Children: A Prospective Randomized 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 |
Khushi Sethia |
| Designation |
Postgraduate resident |
| Affiliation |
Saveetha dental college and hospital |
| Address |
department of pediatriac and preventive dentistry, Saveetha Dental College and Hospitals
162, Poonamallee High Road, Chennai 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9619493883 |
| Fax |
|
| Email |
152511001.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khushi Sethia |
| Designation |
Postgraduate resident |
| Affiliation |
Saveetha dental college and hospital |
| Address |
department of pediatric and preventive dentistry, Saveetha Dental College and Hospitals
162, Poonamallee High Road, Chennai 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9619493883 |
| Fax |
|
| Email |
152511001.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Sethia |
| Designation |
Postgraduate resident |
| Affiliation |
Saveetha dental college and hospital |
| Address |
department of pediatric and preventive dentistry, Saveetha Dental College and Hospitals
162, Poonamallee High Road, Chennai 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9619493883 |
| Fax |
|
| Email |
152511001.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Khushi Sethia |
| Address |
Saveetha Dental College and Hospitals
162, Poonamallee High Road, Chennai 600077 India
|
| 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 |
| Khushi Sethia |
Saveetha Dental College and Hospital, Chennai |
Saveetha Dental College and Hospitals
162, Poonamallee High Road, Chennai 600077 India
Saveetha Dental College and Hospitals
162, Poonamallee High Road, Chennai 600077 India
Chennai
TAMIL NADU |
9619493883
152511001.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no blanket |
Standard behavioural management and anaesthesia procedure only. |
| Intervention |
Weighted blanket |
Weighted blanket (10–15 % of child’s body weight) made of hypoallergenic cotton with evenly distributed pellets placed from shoulders to feet during local anaesthetic procedure |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 – 10 years
ASA I–II health status
Requiring local anaesthesia for dental treatment
No previous intra-oral injection experience
No known allergy to lidocaine
No history of failed or painful dental procedures
Cooperative behaviour (Frankl 3 or 4)
|
|
| ExclusionCriteria |
| Details |
History of painful or invasive medical/dental procedures
Previous negative dental behaviour record
Epilepsy or other neurological disorder
Requirement for sedation or general anesthesia
Medications influencing cortisol or autonomic function (e.g., corticosteroids)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Facial Image Scale (FIS) score measured before starting procedure, mid procedure, immediately after procedure.
Scale range is 1 to 5
Less than 1 is least anxiety
3 is moderate/ neutral anxiety
Greater than 3 is high anxiety or dental phobia. |
same dental appointment single visit assessment
before starting the procedure
mid procedure
Immediately after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate beats per minute recorded using a pulse oximeter
dental anxiety using Facial Image Scale (FIS) |
After blanket placement
Baseline before starting the procedure
mid procedure
Immediately after procedure
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
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 investigates whether weighted blankets, which provide calming deep pressure sensations, can reduce dental anxiety in children during local anaesthesia injections. Twenty children aged 6 to 10 years will be randomly assigned to receive anaesthesia with or without a weighted blanket. Anxiety will be measured using a child-friendly questionnaire (MCDAS) and heart-rate monitoring at five stages of the injection. The study aims to develop a safe, non-drug, child-friendly method to make dental visits more comfortable and reduce the fear of needles. |