| CTRI Number |
CTRI/2025/05/086561 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the effect of motivation(aromatherapy and peer presence) on exercise on healthy Young adults |
|
Scientific Title of Study
|
Evaluation of motivation driven exercise among healthy adults:- A 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 |
SWATI KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
DEPARTMENT OF PHYSIOLOGY G.S.V.M Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7905887411 |
| Fax |
|
| Email |
swatianand1957@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Kanawjia |
| Designation |
Associate professor |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
DEPARTMENT OF PHYSIOLOGY G.S.V.M Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9125330717 |
| Fax |
|
| Email |
drpreeti2411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SWATI KUMARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
DEPARTMENT OF PHYSIOLOGY G.S.V.M Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7905887411 |
| Fax |
|
| Email |
swatianand1957@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self(Swati Kumari junior Resident Department of Physiology GSVM Medical College Kanpur Uttar Pradesh India 277208) |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
G.S.V.M Medical College Kanpur U.P. 208002 |
| Type of Sponsor |
Government 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 |
| SWATI KUMARI |
GSVM MEDICAL COLLEGE KANPUR |
Human Clinical Lab room number 6 DEPARTMENT OF PHYSIOLOGY
Kanpur Nagar
UTTAR PRADESH |
7905887411
swatianand1957@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE G.S.V.M Medical College Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INDIVIDUALS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aromatherapy |
Participants will be exposed to aroma of essential oil with the help of a diffuser |
| Comparator Agent |
Verbal/peer presence |
Participants will be motivated verbally by their peers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent, Enrolled in medical courses,Well nourished, Sedentary not doing regular exercise, Apparantly clinically healthy subjects |
|
| ExclusionCriteria |
| Details |
inability to follow up,any addiction(tobacco/ alcohol),Pregnant females,Psychiatric illness, Musculoskeletal Cardio-respiratory & neural disorder,Specially abled,Intake of routine multivitamins,Chronic medical illness,Any condition which in view of investigator maybe a limiting factor in performing exercise |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate motivation driven exercise performance in healthy subjects |
after the first intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| exercise performance will be better and salivary cortisol levels will be decreased in aromatherapy group as compared to non aromatherapy group |
after the first interventions |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2025 |
| Date of Study Completion (India) |
30/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript submitted |
|
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 controlled trial was conducted to evaluate the independent and combined effects of aromatherapy and peer presence on exercise performance and exercise-induced stress response in healthy young adults. A total of 60 participants aged 18–26 years were randomly allocated into four groups: aromatherapy with peer presence, peer presence alone, aromatherapy alone, and control. Participants performed a standardized treadmill exercise protocol until volitional exhaustion or attainment of the target heart rate. Hemodynamic parameters and salivary cortisol levels were assessed before and after exercise. The study demonstrated that aromatherapy and peer presence were associated with improved exercise tolerance and attenuation of salivary cortisol responses. The combined intervention produced the greatest improvement in exercise duration and cortisol reduction. Factorial analysis demonstrated significant independent effects of aromatherapy and peer presence, while no statistically significant interaction effect was observed. The study was completed according to the approved protocol, and all planned participants were included in the final analysis. |