| CTRI Number |
CTRI/2025/06/089693 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| 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 aromatherapy and music therapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia: A randomized controlled study |
|
Scientific Title of Study
|
Effect of aromatherapy and music therapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia: A randomized controlled 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 |
S Amulya |
| Designation |
Post graduation |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Paediatric and preventive dentistry first floor room number 8
Nalgonda
TELANGANA
508254
India |
| Phone |
9182626721 |
| Fax |
|
| Email |
amulyaamul1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Rajendra Reddy |
| Designation |
Professor and HOD |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Paediatric and preventive dentistry first floor room number 8
Nalgonda
TELANGANA
508254
India |
| Phone |
9391089226 |
| Fax |
|
| Email |
dr.rajendra.reddy.e@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Rajendra Reddy |
| Designation |
Professor and HOD |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Paediatric and preventive dentistry first floor room number 8
Nalgonda
TELANGANA
508254
India |
| Phone |
9391089226 |
| Fax |
|
| Email |
dr.rajendra.reddy.e@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kamineni Institute of Dental Sciences. sreepuram, Dist.Nalgonda, Narketpally, Akkinepallivari Lingotam, Telangana 508254. |
|
|
Primary Sponsor
|
| Name |
S Amulya |
| Address |
Room No: S-6, JR DOCTORSS Residence Ladies Hostel, Beside wings, Narketpally, Akkinepallivari, Nalgonda, Telangana, 508254 |
| 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 |
| Dr S Amulya |
Kamineni Institute of Dental Sciences |
Department of paediatric and preventive dentistry first floor room number 8
Nalgonda
TELANGANA |
9182626721
amulyaamul1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAMINENI INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children between 6 to 9 years undergoing dental treatment under local anesthesia will be recruited. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aromatherapy |
using essential oils like lavender oil to reduce anxiety. 3-4 drops of lavender essential oil. once before administration of local anesthesia. route of administration by inhalation via diffuser. duration 20 minutes. |
| Intervention |
Music therapy |
listening to weightless series music. once for 20 minutes before the administration of local anesthesia. route of administration is auditory via headphones. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged between 6 to 9 years requiring dental treatment.
2. Children who were rated +ve on the Frankl behavior scale.
3. Children with sufficient cognitive skills to complete the self-report scale. |
|
| ExclusionCriteria |
| Details |
1. Children whose parents refused to participate in this study.
2. Children with any systemic diseases or developmental delays.
3. Children with any other respiratory diseases.
4. Children under any medications.
5. Children with acoustic problems.
6. Children who are allergic to lavender essential oils that will be used in this study.
7. Children who are allergic to local anesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulse rate
Oxygen saturation levels
Anxiety levels |
At Base line and 1 minute after administration of local anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 2 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="1"
Months="10"
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
|
Dental anxiety and pain are significant challenges in pediatric dentistry, often leading to non-cooperation during dental procedures and long term dental avoidance. Aromatherapy and Music therapy are non-invasive and patient friendly distraction techniques. Aromatherapy uses essential oils like lavender which have been proven to reduce stress and anxiety by stimulating the olfactory system. Marconi’s union’s weightless series is chosen for this study as it is considered to be one of the world’s most relaxing songs. Music uses auditory stimulation to promote relaxation by stimulating dopamine production, decreasing heart rate and breathing pattern thus mimics state of relaxation and reduce physical markers of anxiety. AIM: The study aims to assess the effect of aromatherapy and music therapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia. OBJECTIVES OF THE STUDY: 1)To evaluate the effectiveness of aromatherapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia. 2)To evaluate the effective of listening to Marconi Union’s weightless (Music therapy) on anxiety reduction in pediatric dental patients for treatment under local anesthesia. 3)To compare the efficacy of aromatherapy and music therapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia. Pulse rate and oxygen saturation will be recorded using portable pulse oximeter (pre-intervention) before and (post-intervention) after Local anesthesia. Anxiety levels will be assessed using venham’s anxiety scale and Facial image scale (pre-intervention) before and (post-intervention) after local anesthesia. Group-1: Control Group Children will not be subjected to either aromatherapy or music therapy. Group-2:Aromatherapy Group Lavender essential oil will be diffused in the treatment room using a ceramic diffuser. 4 drops of aroma oil will be poured on upper plate of ceramic diffuser and candle will be lit below the plate to allow the aroma to disperse throughout the room. Local anesthesia will be administered for the relevant dental procedure to be done. Group-3:Music therapy Group Patient will be made to listen to Marconi Union’s weightless series with wireless headphones before the procedure begins. Local anesthesia will be administered for the relevant dental procedure to be done.
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