| CTRI Number |
CTRI/2026/03/106115 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of music therapy and aromatherapy on anxiety levels in children |
|
Scientific Title of Study
|
Comparitive evaluation of combined effect of music therapy and aromatherapy vs tell show do technique on objective, subjective and cognitive dental anxiety in children - A randomised control 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 Ishi Soni |
| Designation |
Postgraduate student |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Room no. 5, bhojia dental college
Solan
Himachal Pradesh
173205
India
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9988439129 |
| Fax |
|
| Email |
ishisoni21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetika Singh |
| Designation |
Head of Department of Pediatric and Preventuve Dentistry |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Room no. 5, bhojia dental college
Solan
Himachal Pradesh
173205
India
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9540734499 |
| Fax |
|
| Email |
neetika.jasrotia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetika Singh |
| Designation |
Head of Department of Pediatric and Preventuve Dentistry |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Room no. 5, bhojia dental college
Solan
Himachal Pradesh
173205
India
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9540734499 |
| Fax |
|
| Email |
neetika.jasrotia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhojia Dental College and hospital, Baddi |
|
|
Primary Sponsor
|
| Name |
Bhojia Dental College and hospital |
| Address |
Bhojia Dental college and hospital Bhud Baddi Solan 173205 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Ishi Soni |
Bhojia Dental College and Hospital, Baddi |
Department of pediatric and preventive dentistry, Room no 5,
Bhojia Dental College and hospital, Bhud, Baddi, Solan , Himachal pradesh
Solan
HIMACHAL PRADESH |
9988439129
ishisoni21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Bhojia Denatl College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children requiring pit and fissure sealant application on permanent molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aromatherapy and music therapy
|
Music therapy combined with lavender aromatherapy will be used as the intervention during the dental procedure. Aromatherapy will be administered using lavender essential oil Lavandula angustifolia. Two drops of lavender essential oil will be added to distilled water in an electric diffuser and activated approximately twenty minutes before the child enters the operatory and will continue throughout the procedure.
Music therapy will consist of soothing instrumental relaxation music delivered through over the ear wireless headphones. The music will be played at a comfortable volume below sixty decibels to avoid discomfort and to mask dental operatory sounds such as suction and handpiece noise. The aim of this intervention is to reduce dental anxiety through multisensory modulation by stimulating auditory and olfactory pathways.
|
| Comparator Agent |
Tell Show Do Technique |
The comparator will be the conventional Tell Show Do behaviour management technique which is routinely used in pediatric dentistry. In this technique the dental procedure will first be explained to the child in simple child friendly language Tell. The dentist will then demonstrate the dental instruments and procedure on a model finger or dental mirror outside the mouth Show. After the child understands the procedure the actual treatment will be performed Do.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Female |
| Details |
Children aged 6-12 years.
Children requiring pit and fissure sealant on permanent molars
Children visiting the dental clinic for their first dental appointment
Children displaying positive or negative behaviour |
|
| ExclusionCriteria |
| Details |
Children with olfactory dysfunction, respiratory conditions (asthma, allergies), or recent upper respiratory infections.
Children with known hypersensitivity or intolerance to lavender essential oil or fragrance.
Children currently taking anti-anxiety, sedative or stimulant medications.
Children showing definitely positive or definitely negative behaviour
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
They include changes in dental anxiety measured through:
Physiological anxiety : By measuring pulse rate and oxygen saturation (Spo2) measured using pulse oximeter
Subjective anxiety : Using Facial image scale, Venham Picture Scale
Cognitive anxiety : Using Modified Child Dental Anxiety Scale |
All the above parameteres will be measured before starting the procedure and once the procedure is completed on the same day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the overall patient cooperation & behaviour response |
They will be measured pre treatment & post treatment on the same day. |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
24/03/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ishisoni21@gmail.com].
- For how long will this data be available start date provided 10-02-2026 and end date provided 10-02-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dental anxiety is common in children and can affect cooperation and quality of dental treatent Conventional behaviour management techniques such as Tell Show Do are widely used but they may not adequetly address sensory triggers such as dental sounds and clinical environment Music therapy and aromatherapy are simple safe and non pharmacological methods that can help reduce anxiety by promoting relaxation The present randomized control trial aims to evaluate the combined effect of music therapy and aromatherapy compared with Tell Show Do techniwue in reducing dental anxiety among children aged 6 to 12 years undergoing pit and fissure sealant application A total of 156 children will be randomly alloated into two groups Anxiety will be asessed using Facial Image Scale Venham Picture Test Modified Child Dentl Anxiety Scale and oxygen saturation before and ater the treatment |