| CTRI Number |
CTRI/2024/06/069499 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reducing anxiety of child by using writing in the air using leg and eye movement distraction techniques while giving local anesthesia injection. |
|
Scientific Title of Study
|
Effectiveness of a Novel distraction technique versus Eye movement distraction technique on pain perception and anxiety during Local anesthesia administration 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 |
DrKSPraveena |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry
Division-7
Room number-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9014513242 |
| Fax |
|
| Email |
praveenasudharshan9966@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S V S G Nirmala |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry
Division-7
Room number-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S V S G Nirmala |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry
Division-7
Room number-7
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Sponsor
Department of Pediatric and Preventive Dentistry
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
524003
Andhra Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Dr KS Praveena |
| Address |
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
524003
Andhra Pradesh
India |
| Type of Sponsor |
Other [Self sponsor] |
|
|
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 K S Praveena |
Narayana Dental College and Hospital |
Division-7
Department of Pediatric and Preventive Dentistry
Nellore
Nellore
ANDHRA PRADESH |
9014513242
praveenasudharshan9966@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Narayana Dental College and Hospital |
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 |
Eye movement distraction |
Eye movement distraction by asking the child to close their eyes and rotate in alternative clockwise directions. This intervention is given throughout the local anesthesia administration for dental procedures in children. |
| Intervention |
Writing in the air using leg distraction |
It diverts the childs attention and reduce anxiety in children.
This intervention is given throughout the local anesthesia administration for dental procedures in children. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children age group of 7-11years who require local anesthesia administration during dental procedures.
Children with no previous dental treatment experience. |
|
| ExclusionCriteria |
| Details |
Any medically and physically compromised children.
Children who do not require local anesthesia in any treatment procedure.
Those who are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of Writing in the air using leg distraction and Eye movement distraction in reducing dental anxiety among children |
At baseline, during local anesthesia administration and after local anesthesia administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine effectiveness of writing in the air using leg distraction & Eye movement distraction in reducing pain among children. |
At baseline, during Local Anesthesia administration & after local anesthesia administration |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/07/2024 |
| 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="9" |
|
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
|
|
Brief Summary
|
Successful LA administration is important for many pediatric dental procedures. Administration of LA itself is painful and anxiety –evoking, which can negatively influence the behavior of the child. Hence, treating pediatric patients with minimal distress and pain has become a predominant objective for every pediatric dentist. Distraction is the technique of diverting the patient’s attention from what maybe perceived as an unpleasant procedure. Distraction techniques addresses psychological components of pain by diverting the focus of the child from anxiety – provoking procedures.
Aim To evaluate the effectiveness of a novel distraction and eye movement distraction technique on pain perception and anxiety during LA administration in children aged 7-11 years.
Objectives To assess the effect of WITAUL distraction technique in reducing dental anxiety and pain during LA administration. To assess the effect of Eye movement distraction in reducing dental anxiety and pain during LA administration. To compare the effectiveness of WITAUL distraction and eye movement distraction during LA administration.
Methodology The present study will be a randomized clinical trial using simple random sampling. A total of 50 healthy children aged 7-11 years who require local anesthesia administration during dental procedure will be included in the study and they will be divided into two groups. Group 1 Writing in the air using leg distraction group Group 2 Eye movement distraction group In both the groups , anxiety levels will be recorded using physiological measure i.e., Pulse Oximeter ( before , during and after LA) and subjective measure by visual analogue scale ( before and after LA). Pain perception will be recorded during LA administration by FLACC scale and after LA administration by Wong-Baker pain scale.
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