| CTRI Number |
CTRI/2025/05/087480 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse led Psycho-education] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Helping adults quit tobacco A study on the role of nurses at AIIMS Tobacco Clinic |
|
Scientific Title of Study
|
A Randomized controlled trial to assess the effectiveness of nurse led psychoeducation on tobacco use and cessation among adults attending TCC clinic at AIIMS NEW DELHI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTI SHARMA |
| Designation |
MSC NURSING STUDENT |
| Affiliation |
AIIMS NEW DELHI |
| Address |
PORTA CABIN 2 College of Nursing AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9717158765 |
| Fax |
|
| Email |
jyotihjp0402@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yumnam Surbala Devi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
PORTA CABIN College of Nursing AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
09953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yumnam Surbala Devi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
PORTA CABIN College of Nursing AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
09953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jyoti Sharma |
| Address |
PORTA CABIN 2 College of Nursing AIIMS NEW DELHI |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jyoti Sharma |
AIIMS NEW DELHI |
RAK OPD TCC clinic 5th floor Room No 519 A wing AIIMS New Delhi
South
DELHI |
09717158765
jyotihjp0402@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H||Substance Abuse Treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led psycho education |
Nurseled psycho education is structured intervention provided among adult attending TCC Clinic Weekly session for 3 weeks for the duration of 45-60 minutes. The intervention in this study focuses on building awareness of tobaccos harmful effects and setting SMART goals for quitting using the 5A and 5R approaches that helps participants manage cravings and withdrawal symptoms through behavioral strategies like chewing gum and distractions and relaxation techniques such as deep breathing |
| Comparator Agent |
standard care |
standard care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults 18 years who use tobacco smoking, smokeless or both
Participants are willing to quit or reduce their tobacco consumption
Participants give informed consent for the study Able to communicate in Hindi or English
|
|
| ExclusionCriteria |
| Details |
Patient who are having any medical and psychiatric illness which affect the interview process
Patients not willing to participate
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Self reported Tobacco cessation by using Timeline Follow back tools |
At the time of recruitment and at 1 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stage of change of tobacco use behaviour measure by Readiness to change questionnaire |
At the time of recruitment & at 1 month follow up |
| Comparison of tobacco use between intervention & control groups |
At the time of recruitment & at 1 month follow up |
| Comparison of readiness to change between intervention & control groups |
At the time of recruitment & at 1 month follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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)
|
The study titled "A Randomized Controlled Trial to Assess the Effectiveness of Nurse-Led Psycho-Education on Tobacco Use and Cessation Among Adults Attending TCC Clinic at AIIMS New Delhi" aims to evaluate the impact of nurse-led interventions on tobacco cessation. It focuses on reducing tobacco usage and increasing readiness to quit among adults attending AIIMS. The structured 3-week psycho-education program addresses awareness, withdrawal coping, and relapse prevention through group sessions. The randomized controlled design, with participants screened based on specific inclusion criteria, ensures robust evaluation. Results will help shape targeted tobacco cessation strategies in resource-limited settings. |