| CTRI Number |
CTRI/2023/04/051826 [Registered on: 20/04/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reducing the pain and anxiety using an interactive toy while giving local injection in children
|
|
Scientific Title of Study
|
The effectiveness of an interactive toy as an active distraction in alleviating dental anxiety and pain while administration of local anesthesia in children - a randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pinjari Meerza Alam |
| Designation |
Post graduate student |
| Affiliation |
Narayana Dental college and hospital |
| Address |
Narayana Dental college and hospital
Chinthareddy Palem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
09492657602 |
| Fax |
|
| Email |
meerzaalam123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNirmala SVSG |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Dental college and hospital |
| Address |
Narayana Dental college and hospital
Chinthareddy Palem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
09492657602 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNirmala SVSG |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Dental college and hospital |
| Address |
Narayana Dental college and hospital
Chinthareddy Palem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
09492657602 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsor
Department of pediatric and preventive dentistry |
|
|
Primary Sponsor
|
| Name |
Dr.P.Meerza Alam |
| Address |
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh |
| Type of Sponsor |
Other [self sponser] |
|
|
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 |
| P Meerza Alam |
Narayana Dental College and Hospital |
Division-7
Department of Paediatric and Preventive Dentistry
Nellore
ANDHRA PRADESH |
09492657602
meerzaalam123@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 |
| Healthy Human Volunteers |
Dental anxiety and Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
colorful musical headset |
This colorful headset has cat ears with LED light which is attractive to the children. |
| Intervention |
Interactive Toy(Dancing Cactus) |
Dancing Cactus is an interactive toy with music, dance and recording of sounds. In this way the child can interact with the toy which helps in reducing dental dental anxiety and pain while administration of local anesthesia in children. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children age group of 4-9 years
2.Healthy children attending the dental hospital
3.Children who are willing to participate and are
able to understand and reply to the questionnaire.
4. Children indicated for dental procedures under
local anesthetia
|
|
| ExclusionCriteria |
| Details |
1. Children with special health care needs.
2. Children with systemic disorders.
3.Children with dental emergency which include
trauma,acute pulpitis, dental abscess, cysts,
pericoronitis etc.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of interactive toy with colourful headset in reducing dental anxiety among children |
Baseline
During administration of LA
After administration of LA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of interactive toy with colourful headset in reducing pain among children |
Before admnistration of LA
After administration of LA |
|
|
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)
|
03/05/2023 |
| 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="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effective pain
control during dental treatment of a paediatric patient is the cornerstone for
successful behaviour guidance. Researchers have found that one of the most provocation aspects of child behaviour
management is poor pain control. A
variety of behavioural management techniques has emerged to manage dental fear
including pharmacological and non-pharmacological methods. Previous
studies have stated that use of distraction during dental treatment is useful
to patients by reducing their distress and in turn decrease their perception of
pain sensation especially during injections with local anesthesia. Previous
studies have stated that use of distraction during dental treatment is useful
to patients by reducing their distress and in turn decrease their perception of
pain sensation especially during injections with local anesthesia. Active forms of
distraction promote a child’s participation involving several sensory
components such as interactive toys, virtual reality, controlled breathing,
guided imagery and relaxation; conversely, passive forms achieve distraction
through a child’s observation of an activity or stimulus rather than their
explicit partaking for example listening to music, watching television.
Aim : The aim of the study is to evaluate the effect of an interactive toy as a distraction technique in reducing the dental anxiety and pain while administration of local anesthesia in children aged 4-9 years.
Objectives : To assess the effect of an Interactive
toy as an active distraction in reducing dental anxiety and pain while
administration of local anesthesia.
· To assess the effect of a colourful
headset with music as a passive distraction in reducing dental anxiety and pain
while administration of local anesthesia.
· To
compare the effectiveness of an Interactive toy and Colorful headset with music
while administration of local anesthesia. Methodology : The present
study will be a randomized clinical trial using block randomisation and are
equally allocated into 1:1 ratio.
Children
aged 4-9 years will be included in the study and they will be divided into two
groups.
Group 1: Children will be given interactive
toy as an active distraction.
Group 2: Children will be given colourful
headset with music as a passive distraction.
The reaction
of children during local anesthesia administration (Infiltration) will be
recorded in terms of anxiety (Modified Venham Picture scale and pulse rate),
and pain perception (Modified Wong-Baker FACES pain rating scale and the Faces,
Leg, Activity, Cry and Consolability scale).
|