| CTRI Number |
CTRI/2024/02/062828 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Different Method of Assessment of Anxiety |
|
Scientific Title of Study
|
Evaluation of Different Methods of Assessment of Anxiety in Pediatric Patients |
| 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 Aishwarya Savakiya |
| Designation |
Post Graduate - Department of Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room no. 9 Department of Pediatrics and Preventive Dentistry. College of Dental Sciences and Research Centre. nr. Navneet Printing Press, Bopal, Manipur, Gujarat
Room No. 9. Department of Pediatrics and Preventive Dentistry. College of Dental Sciences and Research Centre. nr. Navneet Printing Press, Bopal, Manipur, Gujarat
Ahmadabad
GUJARAT
382115
India |
| Phone |
8980898895 |
| Fax |
|
| Email |
patelaishwarya34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anup Panda |
| Designation |
HOD & Prof.- Department of Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room No.9. Department of Pediatric and Preventive Dentistry. College of Dental Sciences and Research Centre. nr. Navneet Printing Press, Bopal, Manipur, Gujarat
Room No.9. Department of Pediatric and Preventive Dentistry. College of Dental Sciences and Research Centre. nr. Navneet Printing Press, Bopal, Manipur, Gujarat
Ahmadabad
GUJARAT
382115
India |
| Phone |
9727800006 |
| Fax |
|
| Email |
dranuppanda76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Savakiya |
| Designation |
Post Graduate - Department of Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room No.9 Department of Pediatric and Preventive Dentistry. College of Dental Sciences and Research Centre. nr. Navneet Printing Press, Bopal, Manipur, Gujarat
Room No.9 Department of Pediatric and Preventive Dentistry. College of Dental Sciences and Research Centre. nr. Navneet Printing Press, Bopal, Manipur, Gujarat
Ahmadabad
GUJARAT
382115
India |
| Phone |
8980898895 |
| Fax |
|
| Email |
patelaishwarya34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics and Preventive Dentistry. College of Dental Sciences and Research Centre, nr. Navneet Printing Press, Bopal, Manipur, Gujarat 382115 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Savakiya |
| Address |
COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE, nr. Navneet Printing Press, Bopal, Manipur, Gujarat 382115 |
| Type of Sponsor |
Other [Self] |
|
|
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 Aishwarya Savakiya |
College of Dental Sciences and Research Centre |
Room No. 9 Department of Pediatrics and Preventive Dentistry. College of Dental Sciences and Research Centrenr. Navneet Printing Press, Bopal, Manipur, Gujarat 382115
Ahmadabad
GUJARAT |
8980898895
patelaishwarya34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Treatment Required |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 - Control group |
Basic behaviour modification techniques, tell-show-do, positive verbal reinforcements, and euphemisms will be applied which will followed by topical application of Lidocaine containing spray to the area of injection 1 min before the local anaesthesia administration.No distraction techniques in this group. Four measurements will be taken before and after the local anaesthesia administration. Four measurements are the Modified Child Dental Anxiety Scale (MCDAS) as a self-report scale, the Clinical Anxiety Rating Scale (CARS) as a behavioural scale, pulse rate and oxygen saturation for physiological evaluation and Galvanic skin response (GSR) for psychophysiological evaluation of dental anxiety. |
| Intervention |
Group 2- Audiovisual distraction |
Audiovisual technique use as a distraction
Basic behaviour modification techniques, tell-show-do, positive verbal reinforcements, and euphemisms will be applied which will followed by topical application of Lidocaine containing spray to the area of injection 1 min before the local anaesthesia administration. Audiovisual distraction techniques will be used while administrating local anesthesia. Four measurements will be taken before and after the local anaesthesia administration. Four measurements are the Modified Child Dental Anxiety Scale (MCDAS) as a self-report scale, the Clinical Anxiety Rating Scale (CARS) as a behavioural scale, pulse rate and oxygen saturation for physiological evaluation and Galvanic skin response (GSR) for psychophysiological evaluation of dental anxiety.
|
| Intervention |
Group 3- Mini Digital Camera Distraction |
Mini digital camera use as a distraction
Basic behaviour modification techniques, tell-show-do, positive verbal reinforcements, and euphemisms will be applied which will followed by topical application of Lidocaine containing spray to the area of injection 1 min before the local anaesthesia administration. Mini digital camera as distraction techniques will be used while administrating local anesthesia. Four measurements will be taken before and after the local anaesthesia administration. Four measurements are the Modified Child Dental Anxiety Scale (MCDAS) as a self-report scale, the Clinical Anxiety Rating Scale (CARS) as a behavioural scale, pulse rate and oxygen saturation for physiological evaluation and Galvanic skin response (GSR) for psychophysiological evaluation of dental anxiety.
|
| Intervention |
Group 4- Hand Puzzle Distraction |
Hand Puzzle as a distraction
Basic behaviour modification techniques, tell-show-do, positive verbal reinforcements, and euphemisms will be applied which will followed by topical application of Lidocaine containing spray to the area of injection 1 min before the local anaesthesia administration. Hand puzzle as distraction techniques will be used while administrating local anesthesia. Four measurements will be taken before and after the local anaesthesia administration. Four measurements are the Modified Child Dental Anxiety Scale (MCDAS) as a self-report scale, the Clinical Anxiety Rating Scale (CARS) as a behavioural scale, pulse rate and oxygen saturation for physiological evaluation and Galvanic skin response (GSR) for psychophysiological evaluation of dental anxiety.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
children demonstrated positive or definitely positive behavior (frakle 3 or 4 behaviour rating scale)
Child’s first dental treatment under local anaesthesia.
Child without any medical and systemic condition.
|
|
| ExclusionCriteria |
| Details |
children demonstrated negative or definitely negative behavior (frakle 3 or 4 behaviour rating scale)
Children without previous dental experience of Local anesthesia
child with any medical and systemic condition |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the validity and reliability of galvanic skin response as a objective measure for assessment of dental anxiety in children.
|
4 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effects of two different distraction technique using mini digital camera and hand puzzle on reduction of anxiety during administration of local anesthesia in children.
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 3 |
|
Date of First Enrollment (India)
|
27/02/2024 |
| 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="4"
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
|
|
Brief Summary
|
112 children will be divided into four groups. Four measurements will be taken before and after the local anaesthesia administration. Four measurements are the Modified Child Dental Anxiety Scale (MCDAS) as a self-report scale (18), the Clinical Anxiety Rating Scale (CARS) as a behavioural scale (19), pulse rate and oxygen saturation for physiological evaluation and Galvanic skin response (GSR) for psychophysiological evaluation of dental anxiety. |