| CTRI Number |
CTRI/2025/02/081487 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Do Aromatherapy, Audiovisual Distraction and Vibration
reduces dental anxiety in children
|
|
Scientific Title of Study
|
Effectiveness of Aromatherapy, Audiovisual Distraction and Vibration in management of dental anxiety in children aged 6-12 years: Randomized 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 |
Dr Dhruvi Godhani |
| Designation |
Post Graduate Student |
| Affiliation |
College of Dental Sciences,Amargadh,Bhavnagar,Gujrat |
| Address |
Department of pediatric and preventive dentistry,divison P , Room no.6, College of dental sciences,amargadh,Bhavnagar,Gujrat
Bhavnagar
GUJARAT
364210
India |
| Phone |
9998403497 |
| Fax |
|
| Email |
dhruvigodhani23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head Of The Department in Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Sciences,Amargadh,Bhavnagar,Gujrat |
| Address |
Department of pediatric and preventive dentistry,,divison P , Room no.6,College of dental sciences,amargadh,Bhavnagar,Gujrat
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head Of The Department in Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Sciences,Amargadh,Bhavnagar,Gujrat |
| Address |
Department of pediatric and preventive dentistry,,divison P , Room no.6,College of dental sciences,amargadh,Bhavnagar,Gujrat
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Sciences, Amargadh, Bhavnagar, Gujarat-364210, India |
|
|
Primary Sponsor
|
| Name |
College of Dental Sciences,Amargadh,Bhavnagar,Gujrat |
| Address |
Department of pediatric and preventive dentistry,divison P , Room no.6, College of dental sciences,amargadh,Bhavnagar,Gujrat- 364210 |
| Type of Sponsor |
Private medical college |
|
|
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 Dhruvi Godhani |
College of Dental Sciences,Amargadh,Bhavnagar,Gujrat |
Department of pediatric and preventive dentistry,divison P , Room no.6, College of dental sciences,amargadh,Bhavnagar,Gujrat- 364210
Bhavnagar
GUJARAT |
9998403497
dhruvigodhani23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A : Tender Love Care (control group). |
Tender Love Care as a comparative agent will be use during LA administration (infiltration). Tender Love Care is associate with provision care, attention and affection for children.
|
| Intervention |
Group B : Aromatherapy in combination with Audio-visual (experimental group 1 )
|
The lavender essential oil will be used as a first intervention to make the room aromatic before starting the treatment.
An electric aroma diffuser (model: psi-eard-miniroundldrwt, by Pure source india) will be used to diffuse essential oil sufficient enough to make the treatment room aromatic and for the audiovisual aid the cartoon video of subjects own choice will be played.
|
| Intervention |
Group C: Aromatherapy in combination with Vibration (experimental group 2 )
|
As the second intervention aroma and vibrating mat combination will be used. vibrating mat (massader mat by Siarth) will be placed on the dental chair and the subjects will seat on vibrating mat through out entire treatment procedure.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy children without any systemic diseases.
2.Children of both sexes
3.Children aged between 6-12 years.
4.Children who require local anaesthesia (infiltration) for extraction
|
|
| ExclusionCriteria |
| Details |
1.Children whose parents refused to participate in this study.
2.Children with any respiratory tract illnesses and common cold.
3.Children with visual and hearing impairments.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess subjects anxiety by RMS pictorial scale |
To assess subjects anxiety before the procedure as well as after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in dental anxiety |
variation of pulse measured using pulse oximeter before and after extraction |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="2"
Months="0"
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
|
The study will be carried out on children aged 6-12 years who will be reporting to the Department of Pediatric and Preventive dentistry, College of Dental Sciences, Amargadh, Bhavnagar, Gujarat to undergo dental treatment procedures which requires extraction requiring local anaesthesia (infiltration). after diagnosis and treatment planning, Written informed consent will be taken before starting the study. A total of 150 children will be taken for the study which will be divided in to 3 different groups. 50 children will be allocate to each group which will be divided in to: Group A : Tender Love Care (control group). Group B : Aromatherapy in combination with Audio-visual (experimental group 1 ) Group C: Aromatherapy in combination with Vibration (experimental group 2 ) The lavender essential oil will be used to make the room aromatic before the treatment starts. An electric aroma diffuser((model: psi-eard-miniroundldrwt, by Pure source india) will be used to diffuse essential oil sufficient enough to make the treatment room aromatic and for the audiovisual aid, cartoon video of their own choice will be played in front of child. Whenever the video is being played aroma will be diffused in the room. In the second group, aroma and vibrating mat combination will there, vibrating mat(massager mat by Siarth) will be placed on the dental chair and child will seat on it during entire treatment time. In the control group TLC approach will be use during LA administration (infiltration). it is associate with provision care, attention and affection for children. This study is designed as a single blind (participants), randomized controlled trial with two parallel groups. Sample will be randomly allocated to the study groups by block randomization by pressure sensitive paper envelop for equal distribution of sample size in study group. In this study physiological parameters will be assessed by using pulse oximeter . Pulse rate will be measured before and after treatment by using pulse oximeter((by DR VAKU). Children’s dental anxiety will be record by using Raghavendra, Madhuri, Sujata Pictorial Scale (RMS Pictorial Scale) before and after the dental treatment. In all groups 2% of lignocaine with 1:80,000 adrenaline [Stim Lidayn] and 30 gauge needle (BD microlane ) will be use. |