| CTRI Number |
CTRI/2024/06/069494 [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 Hands Eyes Mouth distraction and Covering patients vision technique distraction techniques while gives local anesthesia |
|
Scientific Title of Study
|
Comparative evaluation of two behavior guidance techniques in reducing 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 |
Dr K S Praveena |
| 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
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 K S Praveena |
| Address |
Pediatric and Preventive Dentistry
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 |
Covering patient vision distraction |
Covering patient’s vision technique was used where child field of vision will be covered with hand to prevent them from seeing the injection syringe and the needle, throughout the local anesthesia procedure. It diverts the childs attention and reduce anxiety in children. This intervention will be given throughout local anesthesia administration for dental procedures.
|
| Intervention |
Hands Eyes Mouth distraction |
In Hands Eyes Mouth distraction technique children will be asked to close their eyes , open their mouth and count numbers with their fingers continuously and slowly throughout the anesthetic procedure. It diverts the childs attention and reduce anxiety in children.
This Intervention will be given throughout Local anesthesia administration for dental procedures |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children age group of 6-12years 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 compare the effectiveness of Hands Eyes Mouth distraction with Covering patient vision distraction in reducing anxiety among children |
At baseline, during local anesthesia administration and after local anesthesia administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Covering patient vision distraction with Hands Eyes Mouth distraction in reducing anxiety 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
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2024 |
| 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
|
Local anesthesia (LA) plays an important role in many pediatric dental procedures to control pain. However, the local anesthesia can itself provoke anxiety in children. Hence distraction techniques are used in pediatric dentistry to divert childs attention away from noxious stimuli and reduce their dental anxiety.
Aim :To evaluate the effectiveness of Hands-eyes-mouth (HEM) distraction technique and covering patient’s vision technique on pain perception and anxiety during LA administration in children aged 6-12years.
Objectives: •To assess the effect of HEM distraction technique •To assess the effect of Covering Patient’s Vision technique •To compare the effectiveness of HEM distraction and covering patient’s vision technique in reducing dental anxiety and pain during LA administration.
Methodology : The present study will be a randomized clinical trial using simple random sampling. A total of 50 healthy children aged 6-12 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 : Hands-Eyes-Mouth distraction group Group 2 : Covering patient vision 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 Animated Emoji scale ( before LA and after LA) Pain perception will be recorded during LA administration by Sound Eye Motor scale and LA administration by Colored Analogue scale.
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