| CTRI Number |
CTRI/2026/01/100574 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Mental Stress and Tobacco Addiction in the Rural Community of Dankaur |
|
Scientific Title of Study
|
Assessment of Psychological Distress and Nicotine Dependence Among Tobacco Users in a Rural Population of Dankaur |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANSHI AGGARWAL |
| Designation |
Assistant Professor |
| Affiliation |
Noida International University |
| Address |
Department of Physiotherapy, Orthopaedic Division
SOAHS Building, Room 203
Plot No. 1, Yamuna Expressway, Sector 17A
Uttar Pradesh – 203201, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
07428548670 |
| Fax |
|
| Email |
Priyanshiaggarwal28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYANSHI AGGARWAL |
| Designation |
Assistant Professor |
| Affiliation |
Noida International University |
| Address |
Department of Physiotherapy, Orthopaedic Division
SOAHS Building, Room 203
Plot No. 1, Yamuna Expressway, Sector 17A
Uttar Pradesh – 203201, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
07428548670 |
| Fax |
|
| Email |
Priyanshiaggarwal28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANSHI AGGARWAL |
| Designation |
Assistant Professor |
| Affiliation |
Noida International University |
| Address |
Department of Physiotherapy, Orthopaedic Division
SOAHS Building, Room 203
Plot No. 1, Yamuna Expressway, Sector 17A
Uttar Pradesh – 203201, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
07428548670 |
| Fax |
|
| Email |
Priyanshiaggarwal28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
noida international university |
| Address |
Department of Physiotherapy, Orthopaedic Division
SOAHS Building, Room 203
Plot No. 1, Yamuna Expressway, Sector 17A
Uttar Pradesh – 203201, India |
| Type of Sponsor |
Research institution |
|
|
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 Pallavi Prakash |
Noida International University |
Noida International University, Department of physiotherapy, Division of orthopaedics , Room number 203 Gautam Budh Nagar Plot 1, Yamuna Expy, Sector 17A ,Uttar Pradesh 203201 write it wil correct grammer
Gautam Buddha Nagar
UTTAR PRADESH |
07428548670
Priyanshiaggarwal28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(NIIMS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z720||Tobacco use, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 years and above
2. Residents of Dhankaur village for at least 6 months
3. Tobacco use for at least 1 year
|
|
| ExclusionCriteria |
| Details |
1. Individuals with diagnosed psychiatric illness
2. Pregnant women (to avoid confounding with BP)
3. Bedridden or seriously ill individuals
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psychological distress |
one time baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
08/01/2027 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
There is an urgent need to investigate the relationship between psychological distress and nicotine dependence in order to inform the development of integrated, culturally appropriate interventions. Such interventions aim to address both mental stress and tobacco addiction, thereby improving tobacco cessation outcomes and reducing the overall health burden in underserved populations. |