| CTRI Number |
CTRI/2024/07/071039 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring the Effects of Sandalwood Aromatherapy on Anxiety in Children at the Dentist: A Study on Stress Hormones |
|
Scientific Title of Study
|
assessment of salivary cortisol level as stress biomarker in anxious pediatric dental patient before and after sandalwood aromatherapy: a randomized clinical trial |
| Trial Acronym |
SCALE-SA: salivary cortisol assessment for levels of anxiety evaluation with sandalwood aromatherapy |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaya Chhabra |
| Designation |
professor and head |
| Affiliation |
NIMS university jaipur rajasthan |
| Address |
Nims Dental College, Nims University Jaipur Rajasthan 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaya Chhabra |
| Designation |
professor and head |
| Affiliation |
NIMS university jaipur rajasthan |
| Address |
Nims Dental College, Nims University Jaipur Rajasthan 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaya Chhabra |
| Designation |
professor and head |
| Affiliation |
NIMS university jaipur rajasthan |
| Address |
Nims Dental College, Nims University Jaipur Rajasthan 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
9929535666 |
| Fax |
|
| Email |
chaya.chhabra@gmail.com |
|
|
Source of Monetary or Material Support
|
| This study is self-funded and will not receive external financial support |
|
|
Primary Sponsor
|
| Name |
Selfsponsored |
| Address |
Department No 7, Nims Dental College, Nims University Jaipur Rajasthan 303121
|
| Type of Sponsor |
Other [self funded ] |
|
|
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 Simran Bhojwani |
NIMS Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, Department no 7, Nims Dental College and Hospital, Nims University Jaipur Rajasthan 303121
Jaipur
RAJASTHAN |
07038868877
muskan2000f@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NIMS UNIVERSITY RAJASTHAN JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
sandalwood aromatherapy |
exposure of anxious pediatric dental patient to sandalwood aromatherapy and salivary cortisol levels will be checked
duration 1.5 hrs |
| Comparator Agent |
water aromatherapy compared with Sandalwood aromatherapy |
exposure of anxious pediatric dental patients to plain water and compared to sandalwood aromatherapy
duration 1.5 hrs |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children of age group 6–9 years visiting the Department of Pediatric and Preventive Dentistry of NIMS Dental College, Jaipur with routine dental
treatments like restoration with no previous dental experience.
2. Children who are Frankel + ve or Frankel–ve in cooperation. |
|
| ExclusionCriteria |
| Details |
1. Medically compromised and special children.
2. Children with any respiratory tract illnesses or cardiac problems, common
cold, allergy, and acute dental pain. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| measurement of salivary cortisol levels before and after sandalwood aromatherapy to assess its effect on stress reduction in pediatric dental patients |
baseline interventions (before intervention)
immediately after intervention
30 mintues post intervention
1 hour post intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
20/05/2025 |
| Date of First Enrollment (Global) |
30/05/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This randomized clinical trial aims to investigate the effectiveness of sandalwood aromatherapy in reducing stress levels among pediatric dental patients. The study will assess salivary cortisol levels as a biomarker of stress before and after the intervention. Children without underlying medical conditions who experience anxiety during dental procedures will be enrolled. The intervention group will receive sandalwood aromatherapy, while the control group will receive standard care without aromatherapy. Various time points will be measured on the same day, including baseline, immediately post-intervention, and at intervals thereafter. Secondary outcomes may include physiological parameters such as heart rate variability and subjective measures of patient comfort and satisfaction. |