| CTRI Number |
CTRI/2024/06/069355 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Anxiety due to Dental Treatment in Patients Before and After Aromatherapy During Prosthetic Treatment. |
|
Scientific Title of Study
|
Comparative Evaluation Of Dental Anxiety In Patient Undergoing Prosthetic Treatment Before and After Aromatherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Dhananjay Deshmukh |
| Designation |
PG student |
| Affiliation |
Sharad Pawar Dental College And Hospital Sawangi Meghe Wardha Maharashtra India |
| Address |
202 2nd Floor Department Of Prosthodontics Sharad Pawar Dental College and Hospital Sawangi Meghe Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7756922838 |
| Fax |
|
| Email |
shrutid635@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta Kale Pisulkar |
| Designation |
Registrar DMIHER and Professor Department of Prosthodontics and Crown and Bridge |
| Affiliation |
Sharad Pawar Dental College And Hospital Sawangi Meghe Wardha Maharashtra India |
| Address |
202 2nd Floor Department of Prosthodontics Sharad Pawar Dental College and Hospital Sawangi Meghe Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881215746 |
| Fax |
|
| Email |
drsweta15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Dhananjay Deshmukh |
| Designation |
PG student |
| Affiliation |
Sharad Pawar Dental College And Hospital Sawangi Meghe Wardha Maharashtra India |
| Address |
202 2nd floor Department of Prosthodontics Sharad Pawar Dental College and Hospital Sawangi Meghe Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7756922838 |
| Fax |
|
| Email |
shrutid635@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College and Hospital Sawangi Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education And Research Sawangi Meghe Wardha maharashtra India |
| Address |
Datta Meghe Institute of Higher Education And Research Sawangi Meghe Wardha Maharashtra India |
| 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 Shruti Deshmukh |
Sharad Pawar Dental College And Hospital |
202 2nd Floor Department of Prosthodontics and crown and Bridge Sharad Pawar Dental College and Hospital DMIHER Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
7756922838
shrutid635@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee datta meghe institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Who require prosthodontic rehabilitation/treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aromatherapy |
Study group will be administered with 2-5 drops i.e 2-3 ml of lavender essential oil inhalation route with oil diffuser for 10-15 m ins. Further Heart Rate, Blood pressure, Pulse Rate and SPo2 will be checked before and after the treatment in both the groups.
Duration of aromatherapy once before treatment for 10-15 mins
|
| Comparator Agent |
Inhalation of water fumes |
Control group will be asked to inhale the water fumes with the diffuser by inhalation route for 10-15 mins before the treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Mentally or physically healthy patients.
Patient who are willing to participate and give consent.
|
|
| ExclusionCriteria |
| Details |
Paediatric patient
Patients who are mentally or physically challenged and patients having systemic diseases.
Patients unwilling to participate and fill the questionnaire.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will seek to provide empirical evidence supporting the potential use of aromatherapy as a non-pharmacological intervention to alleviate dental anxiety, it will further help in correlating it objectively with vital signs like heart rate, blood pressure, SPO2 and also will help in ultimately enhancing the well-being of dental patients and improving their overall dental care experience. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
Months="6"
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
|
Aromatherapy is the complementary practice of using natural aromatic essential oils for a series of applications, which has been shown to improve mood, and improve cognitive function. Essential oils are volatile liquid substances extracted from plant material by steam distillation or expression. Essential oils offer a new, organic, and safe alternative to relatively risky pharmacological agents. Lavender or Lavandula belonging to the Lamiaceae family, is one of the commonly researched medicinal herbs. This study aims to investigate the efficacy of aromatherapy among adult patients undergoing dental procedures specifically prosthetic treatment with lavender essential oil on reducing subjective anxiety levels, physiological indicators of stress, and in improving the overall quality of life for patients. Physiological indicators of stress such as pulse rate, blood
pressure, and Spo2 will be monitored to objectively measure the impact of aromatherapy on the
autonomic nervous system during dental treatments. Further Assessing patients satisfaction
and comfort levels through self-reported measures, exploring how aromatherapy
influences the overall experience of dental care. |