| CTRI Number |
CTRI/2021/01/030286 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of pain perception in children during LA administration while active, passive and active-passive distraction |
|
Scientific Title of Study
|
Comparative Evaluation of Active, Passive and Active- Passive Distraction Methods To Assess Pain Perception in Pediatric Patients Aged 4 to 8 Years During Administration Of Local Anaesthesia - A Randomised Double Blinded 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 |
Dr Sabreen Gujral |
| Designation |
PG student |
| Affiliation |
MRIIRS |
| Address |
Manav Rachna Dental College,Faculty of Dental Sciences, MRIIRS,Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9821276216 |
| Fax |
|
| Email |
sabreengujral@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hind Pal Bhatia |
| Designation |
Professor |
| Affiliation |
MRIIRS |
| Address |
Manav Rachna Dental College,Faculty of Dental Sciences, MRIIRS,Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9811100192 |
| Fax |
|
| Email |
hindbhatia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabreen Gujral |
| Designation |
PG student |
| Affiliation |
MRIIRS |
| Address |
Manav Rachna Dental College,Faculty of Dental Sciences, MRIIRS,Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9821276216 |
| Fax |
|
| Email |
sabreengujral@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS |
|
|
Primary Sponsor
|
| Name |
Dr Sabreen Gujral |
| Address |
Manav Rachna Dental College, Faculty of Dental Sciences, Manav Rachna International Institute of Research Sciences, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
|
| Type of Sponsor |
Other [Self] |
|
|
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 Sabreen Gujral |
Manav Rachna Dental College |
Faculty of Dental Sciences,Department of Pedodontics and Preventive Dentistry, Room no. 9, Manav Rachna International Institute of Research Sciences, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA |
9821276216
sabreengujral@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manav Rachna Dental College |
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 |
Active Distractor- Compressible softball, Passive Distractor- VR eyeglasses, Active- Passive Distractor- Combination of both tools. |
The distracting tool will be provided to the patient and LA will be administered. Compressible ball will be provided in the hand and child will be asked to compress it while LA is administered. For passive distraction age appropriate video will be played for the child. in combination group both agents will be provided |
| Intervention |
LA administration and assessing pain perception using FLACC scale. |
Distracting tool will be provided, LA will be administered and pain perception will be recorded using FLACC scale, checking face, legs, activity, cry and consolability of the child |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 4-8 years
2. Presence of teeth with pulp involvement in which need of pulpal therapy necessitates the administration of local anaesthesia.
3. Co-operative patients (Frankl’s Behaviour Rating Scale – Positive + and Definitely Positive ++)
|
|
| ExclusionCriteria |
| Details |
1. Children with sensory disabilities
2. Previous experience with intraoral injections.
3. Allergy to Lignocaine Hydrochloride
4. History of systemic illness
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find a effective distraction technique for LA administration among VR glasses, softball compression or combination of both.The effectiveness will be measured using FLACC scale.The FLACC scale includes components of Face, Legs, Activity, Cry and Consolability. The primary outcome is to check if the given distraction tool is effectively distracting the child during LA administration which will be observed using the FLACC scale.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare between active distraction (softball compression), passive distraction (VR eye glasses) and active-passive distraction (VR eye glasses and softball compression) method for LA administration. The secondary outcome includes assessing which group out of the three were effectively distracted with the tool they were provided with. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/01/2021 |
| Date of Study Completion (India) |
01/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to evaluate active, passive and active-passive distraction methods for assessment of pain perception in patients aged 4 to 8 years during administration of local anaesthesia. The objective is to determine the effect of ACTIVE DISTRACTION (SOFTBALL COMPRESSION AND RELAXATION) as a distraction method in assessing dental pain perception during administration of local anaesthesia, the effect of PASSIVE DISTRACTION (VIRTUAL REALITY EYEGLASSES) as a distraction method in assessing dental pain perception during administration of local anaesthesia, the effect of ACTIVE-PASSIVE DISTRACTION (SOFTBALL COMPRESSION AND RELAXATION ALONG WITH VIRTUAL REALITY EYEGLASSES) as distraction method in assessing dental pain perception during administration of local anaesthesia and to compare dental pain perception during administration of local anaesthesia using above three techniques. The children will be grouped in Group A, B and C according to the distraction method to be used. LA will be administered. A second operator of Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College will assess the children’s pain reaction during the injection procedure using FLACC (Face, Legs, Activity, Cry and Consolability) BEHAVIOURAL ANXIETY/PAIN ASSESSMENT SCALE
|