| CTRI Number |
CTRI/2024/11/076166 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the effect of breathing exercise using bubble blower in children aged 6 to 10 years on pain and anxiety during dental anesthesia delivery. |
|
Scientific Title of Study
|
Evaluating the effect of breathing exercise using a bubble blower on anxiety and pain during inferior alveolar nerve block (IANB) in children aged 6 to 10 years: A Randomized Clinical Trial |
| Trial Acronym |
BE, IANB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NIRBHAY VASHISTHA |
| Designation |
Postgraduate Student |
| Affiliation |
RUHS college of dental sciences, Shastri nagar, Jaipur, Rajasthan, 302016 |
| Address |
Room no. 7, Department of Pediatric and Preventive Dentistry, RUHS college of dental sciences, Shastri nagar, Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
9829599687 |
| Fax |
|
| Email |
nibhaylive234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambika Singh Rathore |
| Designation |
Professor and Head of Department |
| Affiliation |
RUHS College Of Dental Sciences |
| Address |
Room no. 7, Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri nagar
Jaipur
RAJASTHAN
302016
India |
| Phone |
8107132663 |
| Fax |
|
| Email |
dr.ambika.rathore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambika Singh Rathore |
| Designation |
Professor and Head of Department |
| Affiliation |
RUHS College Of Dental Sciences |
| Address |
Room no. 7, Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri nagar
Jaipur
RAJASTHAN
302016
India |
| Phone |
8107132663 |
| Fax |
|
| Email |
dr.ambika.rathore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 7, Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri Nagar, Jaipur, 302016 |
|
|
Primary Sponsor
|
| Name |
Dr Nirbhay Vashistha |
| Address |
Room No. 7, Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri Nagar, Jaipur, 302016 |
| 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 Nirbhay Vashistha |
RUHS College Of Dental Sciences |
Room No. 7 Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri Nagar, 302016
Jaipur
RAJASTHAN |
9829599687
nirbhaylive234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee RUHS CDS Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
intervention and behaviour management. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bubble Blower Breathing Exercise |
Breathing Exercise will be advised, and asked to record every practice in a chart prepared by the investigator for (1 week).
The child will be asked to breathe during Inferior alveolar nerve block injection exactly like the Breathing Exercise they practiced at home
|
| Comparator Agent |
No use of bubble blower |
Conventional Inferior alveolar nerve block will be performed without the use of bubble blower breathing exercise. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Frankl’s behavior rating 3-4
Aged 6 to 10 year-old with moderate to severe anxiety (score 3 to 5 of FIS)
Requiring pulp therapy or extraction of primary mandibular molars
|
|
| ExclusionCriteria |
| Details |
Uncooperative behavior of patient
Use of analgesic before treatment
Previous history of dental treatment, systemic illnesses, physical or intellectual disabilities, or anesthetic allergy.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intensity of pain |
At Baseline and 1 week after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| anxiety assessment |
Baseline & 1 week after intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/11/2024 |
| 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="15" |
|
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
|
AIM: To evaluate the effect of breathing exercise using BUBBLE BLOWER on anxiety and pain during inferior alveolar nerve block (IANB) in children aged 6 to 10 years.
OBJECTIVE: - To assess intensity of pain using Wong-Baker FACES Pain rating scale (WBFPS) and Faces, Legs, Activity, Cry and Consolability scale (FLACC)
- To assess anxiety using Facial Imaging Scale (FIS).
The healthy children’s aged between 6-10 years, who reported in the Department of Pediatric and Preventive Dentistry of RUHS College Of Dental Sciences, Jaipur that met the defined inclusion criteria were recruited to participate in this clinical study.
About 40 children are randomized into two groups. The first group received the instruction of BE as well as a commercial bubble blower at first visit. Patients and their parents are asked to practice with the bubble blower 4–5 times daily for 7 days and record every practice in a chart prepared in advance by the investigator. The second group did not receive BE instruction nor were they given bubble blower at the first visit. After 7 days, during second visit L.A. will be introduced in both the groups.
Pre-treatment baseline anxiety will be recorded using the FIS for all the children and pulse rate will be measured at first visit. Procedural pain will be assessed using Faces, Legs, Activity, Cry and Consolability scale (FLACC) and WBFPS. Finally, anxiety will be again recorded after procedure & the data were evaluated using statistical analysis |