| CTRI Number |
CTRI/2025/10/096335 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Reducing dental anxiety in children during local anaesthetic injection: Comparing acupressure alone and acupressure with audiovisual distraction |
|
Scientific Title of Study
|
Comparative Efficacy of Acupressure Versus Acupressure Combined with Audiovisual Distraction for Anxiety Reduction in Children During Inferior Alveolar Nerve Block (IANB): A Single-Blinded Randomised Controlled 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 |
Geetanjali Mahajan |
| Designation |
PG Resident (Department of Pediatric and Preventive Dentistry) |
| Affiliation |
Saveetha Dental College and Hospitals, Saveetha University, Chennai |
| Address |
Clinic-28 (Department of Pediatric and Preventive Dentistry)
5th Floor
Saveetha Dental College and Hospitals
Poonamallee High Road,Velappanchwadi, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8198857999 |
| Fax |
|
| Email |
geetanjalimahajan2603@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Geetanjali Mahajan |
| Designation |
PG Resident (Department of Pediatric and Preventive Dentistry) |
| Affiliation |
Saveetha Dental College and Hospitals, Saveetha University, Chennai |
| Address |
Clinic-28 (Department of Pediatric and Preventive Dentistry)
5th Floor
Saveetha Dental College and Hospitals
Poonamallee High Road,Velappanchwadi, Chennai
TAMIL NADU
600077
India |
| Phone |
8198857999 |
| Fax |
|
| Email |
geetanjalimahajan2603@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geetanjali Mahajan |
| Designation |
PG Resident (Department of Pediatric and Preventive Dentistry) |
| Affiliation |
Saveetha Dental College and Hospitals, Saveetha University, Chennai |
| Address |
Clinic-28 (Department of Pediatric and Preventive Dentistry)
5th Floor
Saveetha Dental College and Hospitals
Poonamallee High Road,Velappanchwadi, Chennai
TAMIL NADU
600077
India |
| Phone |
8198857999 |
| Fax |
|
| Email |
geetanjalimahajan2603@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Geetanjali Mahajan |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry
5th floor
Saveetha Dental College and Hospitals, Poonamallee High Road, Chennai |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Geetanjali Mahajan |
Saveetha Dental College and Hospitals, Saveetha University, Chennai |
Clinic 28, Department of Pediatric and Preventive Dentistry
5th floor
Chennai
TAMIL NADU |
8198857999
geetanjalimahajan2603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine IANB plus acupressure
|
Acupressure:
Points: Shenmen, Shan points
Method: Vaccaria seeds on adhesive tape applied after cleaning ear with alcohol swab.
Timing: Applied 2 min before IANB, kept during injection.
Stimulation: Gentle pressure for 60–90 sec at placement.
|
| Intervention |
Lignocaine IANB, acupressure plus audiovisual distraction |
Acupressure points; Shenmen, Shan
Use vaccaria seeds on adhesive tape applied after cleaning ear with alcohol swab
Applied for 2 mins before , kept during injection
Gentle pressure for 60-90 secs at placement
Age-appropriate animated video using VR goggles/tablet started 2 min before IANB and continued through injection. |
| Comparator Agent |
Only lignocaine IANB (control group) |
No adjunctive intervention before or during IANB.
Routine local anesthesia procedure performed. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 6 to 12 years requiring IANB for routine dental treatment.
2. ASA I or II (healthy or mild systemic illness).
3. Able to follow instructions and provide assent; parental consent obtained.
4. Willing to undergo acupressure with or without AVD or VR.
|
|
| ExclusionCriteria |
| Details |
1. Ear infections, skin lesions, or allergy to adhesive materials.
2. Epilepsy, motion sickness, cognitive or communication disorders, or visual/hearing impairments preventing participation.
3. Use of anxiolytics, sedatives, or analgesics within 24 to 48 hrs.
4. Allergy to local anaesthetics or study materials.
5. Acute systemic illness or contraindication for IANB. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in dental anxiety scores measured using the Modified Child Dental Anxiety Scale (MCDAS) from baseline to post-procedure, compared across the three groups.
|
Dental anxiety (MCDAS)
1. Baseline (T0): Before intervention (while seated, prior to IANB).
2. Post-procedure (T3): After completion of IANB injection.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Score on Wong Baker FACES Pain Rating Scale, FLACC scale immediately after IANB. |
At baseline, during injection & post injection |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/11/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This single blinded randomized controlled trial aims to evaluate and compare the effectiveness of auricular acupressure alone and auricular acupressure combined with audiovisual distraction ie AVD or VR in reducing dental anxiety, physiological stress, and pain perception in children undergoing inferior alveolar nerve block. A total of 90 healthy children aged 6 to12 years requiring IANB will be randomly allocated into three equal groups. Group 1 Control with no intervention. Group 2 Auricular acupressure at Shenmen, Shen points etc, applied bilaterally 2 minutes before and during IANB. Group 3 Same acupressure plus AVD using age appropriate animated videos or VR. Primary outcome is Change in MCDAS anxiety scores from baseline to post procedure. Secondary outcomes is Pulse rate, SpO2, Wong Baker FACES pain score, and FLACC behavioural pain score. Data will be statistically analysed using the Kruskal Wallis test for between group comparisons and Friedman test for within group comparisons across time intervals, with significance set at p than 0.05. This study is expected to clarify whether combining acupressure with AVD provides a synergistic benefit in reducing dental anxiety and improving behaviour during IANB in children.
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