| CTRI Number |
CTRI/2025/01/079524 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
An experimental study comparing the effects of aromatherapy and acupressure on pain during inferior alveolar nerve block injection in children aged 6 to 10.
|
|
Scientific Title of Study
|
Comparative evaluation of acupressure and aromatherapy on pain during Inferior Alveolar Nerve Block Injection in Children Aged 6-10 Years Old - An Experimental Study.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Gurharikar |
| Designation |
Senior Lecturer |
| Affiliation |
VSPM Dental College and Research centre, Nagpur |
| Address |
Department of paediatric and preventive dentistry, room no 301, VSPM Dental College and Research centre
Hingna Rd, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9529021483 |
| Fax |
|
| Email |
ayushi.gurharikar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ayushi Gurharikar |
| Designation |
Senior Lecturer |
| Affiliation |
VSPM Dental College and Research centre, Nagpur |
| Address |
Department of pediatric and preventive dentistry, Room no 301, VSPM Dental College and Research centre
Hingna Rd, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9529021483 |
| Fax |
|
| Email |
ayushi.gurharikar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Ayushi Gurharikar |
| Designation |
Senior Lecturer |
| Affiliation |
VSPM Dental College and Research centre, Nagpur |
| Address |
Department of paediatric and preventive dentistry, room no 301, VSPM Dental College and Research centre
Hingna Rd, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9529021483 |
| Fax |
|
| Email |
ayushi.gurharikar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acupressure health care system 3-2-1/5, near kumar theatre, Kachiguda station rd, Kachiguda, Hyderabad, Telangana 500027 |
|
|
Primary Sponsor
|
| Name |
Acupressure healthcare system hyderabad |
| Address |
3-2-1/5, Nr.Kumar Theatre, Kachiguda station Rd,Kachiguda, Hyderabad, Telangana 500027 |
| Type of Sponsor |
Other [Health and beauty shop in Hyderabad ] |
|
|
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 |
| DrAyushi Gurharikar |
Vspm dental college and research centre, nagpur |
Department of pediatric and preventive dentistry, room no 301, Hingna Rd, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA |
9529021483
ayushi.gurharikar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, RDDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K027||Dental root caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupressure |
Acupressure bead will be applied on extra one point during inferior alveolar nerve block injection 10 mins prior to the treatment till end of extraction. |
| Comparator Agent |
Aromatherapy |
Aromatherapy would be carried out throughout the treatment by using aerial dispersion via electronic glass diffusers during inferior alveolar nerve block injection |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children in the age group 6-10-year.
2.Children indicated for at least one clinical session of extraction requiring inferior alveolar nerve block.
3. Children with no acute pain.
|
|
| ExclusionCriteria |
| Details |
1.Active infection at the site of injection
2.Children allergic to local anesthetic agents.
3.Children with prior experience of local anesthetic injection.
4.Children with pre-operative pain.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effect of acupressure and aromatherapy on pain of injection during IANB injection will be assessed. |
At the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the acceptance of 2 different supplementary treatments (aromatherapy & acupressure) by the patient. |
at tha baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pain and anxiety during injecting LA is a common problem in pediatric dentistry. The continuous necessity to incorporate alternate techniques into clinical practice led to the introduction of a number of methods that have been suggested to reduce the pain induced by infiltration of local anesthesia agents. One such pain control method is Acupressure, which has been shown to be effective for relieving a variety of pains in different populations. Another method is aromatherapy, many claims have been made relating to the benefits of aromatherapy, most research has focused on its use to manage depression, anxiety, muscle tension, sleep disturbance, nausea, and pain. Considering the drawbacks of acupressure and the positive aspect of aromatherapy, this study proposes the comparison between the effect of acupressure and aromatherapy on pain of injection during IANB Block in children. Eligible children of 6-10 year old are randomized into three group :- Group 1 - Control group Group 2 - Acupressure group Group 3 - Aromatherapy group
Pre-existing anxiety will be recorded using the Modified child dental anxiety scale. Pain on injection: The discomfort of the injections will be recorded. Subjectively- By Wong-Baker FACES Pain Rating Scale (FPS). Objectively - By Sound, Eye & Motor (SEM) scale ratings will be performed from the video recordings by investigator 2. Subjective and objective measurement will be recorded in customized case record proforma. The data collected will be analyzed for further progress.
|