| CTRI Number |
CTRI/2025/09/095261 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Weighted Blankets in reducing Fear and Pain of injections in Kids During Dental treatment
|
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Scientific Title of Study
|
Effectiveness of Weighted Blanket-Assisted Deep Pressure Stimulation in Reducing Anxiety and Pain During Local Anesthetic Injection for Pulpectomy in Children Aged 6–12 Years : A 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 |
Dr. Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD of Department Of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner
102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD of Department Of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
102, Department of Pediatric and Preventive Dentistry, SMBT Dental college and Hospital, Amrutnagar, Ghulewadi, Sangamner
102,Department of Pediatric and Preventive Dentistry, SMBT Dental college and Hospital, Amrutnagar, Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaya Kumar Kulkarni |
| Designation |
Professor and HOD of Department Of Pediatric and Preventive Dentistry |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar,Ghulewadi, Sangamner
102, Department of Pediatric and Preventive Dentistry, SMBT Dental College and Hospital, Amrutnagar,Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8830483436 |
| Fax |
|
| Email |
vinayakumar53@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital, Amrutnagar, Ghulewadi, Sangamner, Ahmednagar, Maharashtra, India. Pincode-422608 |
|
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Primary Sponsor
|
| Name |
SMBT Dental College |
| Address |
Amrutnagar, Ghulewadi, Sangamner, Ahmednagar, Maharashtra, India. Pincode- 422608 |
| Type of Sponsor |
Other [Private Dental College and Hospital] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinaya Kumar Kulkarni |
SMBT Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, Division/Room No.102, Amrutnagar, Ghulewadi, Sangamner, Maharashtra, India, Pincode-422608
Ahmadnagar
MAHARASHTRA |
8830483436
vinayakumar53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pulpectomy procedure under local anesthesia will be done conventionally without weighted blanket (negative control)
|
Group B Control Group [without weighted blanket group] (n = 30)
Children in this group will be treated conventionally for pulpectomy procedure without the use of a weighted blanket.
They will be seated in the same operatory setup and allowed a 5 minute adaptation period without any sensory aids.
Baseline pulse rate and anxiety score Will be recorded.
Local anesthesia will be administered by the same pediatric dentist using the same technique and anesthetic agent as used for Group A.
Post injection, pain will be assessed using the Wong-Baker FACES Pain Scale, and pulse rate and anxiety (Modified Venham scale) levels will be reevaluated.
|
| Intervention |
Pulpectomy procedure under local anesthesia will be done using weighted blanket |
Group A Weighted Blanket Group (n = 30)
Children in this group will be gently covered with a weighted blanket (approximately 10% of their body weight), which provided deep pressure stimulation.
The blanket will be placed over the child’s lap and shoulders while they sat on the dental chair, ensuring comfort and safety.
The child remained under the weighted blanket for 5 minutes before the administration of local anesthesia to allow acclimatization and activation of calming sensory input.
The local anesthetic injection will be then administered for the pulpectomy procedure.
The weighted blanket will be remained in place throughout the administration of injection and pulpectomy procedure. Immediately following the injection, the child will be asked to rate their pain using the Wong-Baker FACES Pain Scale.
Pulse rate and Anxiety (Modified Venham scale) will be recorded again post-injection.
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 6 and 12 years requiring pulpectomy procedure
Medically healthy children
Demonstrated cooperative or potentially cooperative behaviour using Frankl behaviour rating scale 3 or 4
No previous history of pulpectomy procedures
Ability to understand and respond to pain assessment scales
|
|
| ExclusionCriteria |
| Details |
Diagnosed sensory or neurodevelopmental disorders Eg. ASD, ADHD
Known allergies to the materials used in weighted blankets Eg. cotton, PET pellets
Presence of orthopaedic or musculoskeletal conditions that contraindicate use of weighted blankets
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
The implementation of weighted blankets during pulpectomy procedures is anticipated to significantly attenuate pediatric dental anxiety, foster enhanced patient cooperation, and reduce the incidence of disruptive behaviors. Furthermore, by facilitating autonomic nervous system modulation, this non-pharmacological intervention may contribute to the physiological regulation of stress responses and diminish reliance on sedation or other pharmacological modalities.
|
Objective assessment of anxiety will be evaluated by utilising a digital finger pulse oximeter at three different time intervals from T0 to T2
T0 Before the treatment
T1 During the treatment
T2 After the treatment
Subjective assessment of anxiety will be evaluated by using modified Venham scale at two intervals
T0 Before the treatment
T1 After the treatment
Wong-Baker FACES Pain Scale will be used to evaluate the pain immediately after the administration of local anesthesia.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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Brief Summary
|
Brief Summary
This randomized controlled trial aims to evaluate the effectiveness of weighted blanket-assisted deep pressure stimulation in reducing anxiety and pain during local anesthetic injection for pulpectomy procedures in children aged 6–12 years. A total of 60 medically healthy, cooperative children will be randomly allocated into two groups: one receiving pulpectomy with a weighted blanket and the other without. Objective anxiety will be assessed using pulse oximeter-based heart rate monitoring, while subjective measures will include the Modified Venham Scale for anxiety and the Wong–Baker FACES Pain Scale for pain perception. The intervention involves placing a commercially available, appropriately sized weighted blanket (10–20% of body weight) over the child during treatment. The study hypothesizes that deep pressure stimulation through weighted blankets can serve as a safe, non-invasive method to reduce dental anxiety and pain, potentially minimizing the need for pharmacological behavior management strategies in pediatric dental care.
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