| CTRI Number |
CTRI/2024/06/069124 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reducing the anxiety and pain using origami and puzzle game while giving local injection in children |
|
Scientific Title of Study
|
The effectiveness of origami and puzzle game in alleviating dental anxiety and pain perception during local anaesthesia 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 |
P Sravya |
| 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
Andhra Pradesh
524003
India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9618905543 |
| Fax |
|
| Email |
sravyapuvvada34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Sravya |
| 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
Andhra Pradesh
524003
India
ANDHRA PRADESH
524003
India |
| Phone |
9618905543 |
| Fax |
|
| Email |
sravyapuvvada34@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
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 |
|
|
Primary Sponsor
|
| Name |
Dr P Sravya |
| Address |
Narayana Dental College and Hospital
Chinthareddypalem
Nellore
Andhra Pradesh
INDIA
524003 |
| 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 P Sravya |
Narayana dental college and hospital |
Division-7
Department of Pediatric and Preventive Dentistry
Nellore
Andhra Pradesh
Nellore
ANDHRA PRADESH |
9618905543
sravyapuvvada34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Narayana Dental collge and Hospital |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Origami distraction technique |
In Origami distraction technique an origami paper will be given to the child before LA administration and will be asked to fold it according to the instructions printed on it which eventually forms a shape of animal or a bird in this way the child can be distracted which helps in reducing dental anxiety and pain while administration of local anesthesia |
| Intervention |
Puzzle game |
In puzzle game distraction technique a jigsaw puzzle consisting of a different pictures printed on cardboard with different shapes will be given to the child before Local anesthesia administration and will be asked to arrange together to form a picture in this way the child can be distracted which helps in reducing dental anxiety and pain while administration of local anesthesia |
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children age group of 5-10 years with no previous LA exposure
Healthy children attending the dental hospital
Children who are willing to participate
Children indicated for dental procedures under Local anaesthesia
|
|
| ExclusionCriteria |
| Details |
Children with any systemic disorders and special health care needs
Children with a previous history of LA exposure
Children with dental emergency which include trauma, acute pulpitis, dental abscess, cysts, pericoronitis etc.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is to determine the effectiveness of puzzle game with origami in reducing dental anxiety among children |
Baseline
During administration of LA
After administration of LA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study is to determine the effectiveness of puzzle game with origami in reducing pain among children |
During administration of Local anesthesia
After administration of Local anesthesia |
|
|
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)
|
24/06/2024 |
| 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="2"
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
|
Dental anxiety is commonly experienced among children especially during their first dental visit. This can influence their behavior and can also cause negligence of treatment, impacting their health negatively. Play therapy and good parent cooperation can minimize or reduce children’s anxiety during treatment. Origami and puzzle game are a promising, cost effective, nonpharmacological technique to reduce hospitalized anxiety and can be used to enhance intellectual and cognitive process.
Aim To compare the effectiveness of Origami and Puzzle game as distraction techniques in reducing dental anxiety and pain in children during local anaesthesia administration.
Objectives • To assess the effectiveness of a puzzle game as a distraction technique in reducing dental anxiety and pain during administration of local anesthesia • To assess the effectiveness of an Origami as a distraction technique in reducing dental anxiety and pain during administration of local anaesthesia • To compare the effectiveness of a Puzzle game and Origami in reducing dental anxiety and pain during administration of local anaesthesia Methodology The present study will be a randomized clinical trial ,a total of 50 healthy children aged 5-10 years who require LA administration during dental procedures will be selected and they will be divided into two groups (25 in each group) using simple randomization. Group1 Puzzle game distraction technique Group2 Origami distraction technique. In both the groups, anxiety level is recorded using subjective measure (Facial image scale) ,whereas physiological measure (pulse rate by pulse oximeter) is recorded . Pain perception is recorded using objective measure (FLACC) and using subjective measure (Faces pain scale- revised).
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