| CTRI Number |
CTRI/2025/09/095265 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Brief Intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Nurse Led Brief Intervention on Dependence and Readiness to Change Behavior among Individuals using Smokeless Tobacco attending Dental OPD at AIIMS Jodhpur |
|
Scientific Title of Study
|
Effectiveness of Nurse-Led Brief Intervention on Dependence and Readiness to Change Behavior among Individuals using Smokeless Tobacco attending Dental OPD at AIIMS Jodhpur: A Quasi-Experimental Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gangani Flago |
| Designation |
M.Sc.Nursing Student |
| Affiliation |
College of Nursing, All India Institute of Medical Sciences, Jodhpur |
| Address |
Room no.406,Third floor, Hostel no.3,Near Gate no.6,AIIMS Residential road, Heavy Industrial Area Phase II, Basni, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9337471335 |
| Fax |
|
| Email |
ganganiflago19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Aashish Parihar |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, All India Institute of Medical Sciences, Jodhpur |
| Address |
Cabin no.103, First floor, College of Nursing, AIIMS Jodhpur, Heavy Industrial Area Phase II, Basni, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9660314782 |
| Fax |
|
| Email |
ap1407@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Aashish Parihar |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, All India Institute of Medical Sciences, Jodhpur |
| Address |
Cabin no.103, First floor, College of Nursing, AIIMS Jodhpur, Heavy Industrial Area Phase II, Basni, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9660314782 |
| Fax |
|
| Email |
ap1407@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| No monetary or material support from external agencies. Study is self-funded by the Principal Investigator and conducted as part of postgraduate dissertation work under All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [N/A] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Aashish Parihar |
All India Institute of Medical Sciences Jodhpur |
Department of Dentistry OPD,2nd floor,Room number 211,
Basni heavy industrial area phase-2 342005 Jodhpur
Jodhpur
RAJASTHAN |
9660314782
ap1407@rediffmail.com |
| Gangani Flago |
All India Institute of Medical Sciences Jodhpur |
Department of Dentistry OPD,2nd floor,Room number 211, Basni heavy industrial area phase-2 342005 Jodhpur
Jodhpur
RAJASTHAN |
9337471335
ganganiflago19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS,Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Control group will receive Usual Standard Routine care and Intervention group will receive Nurse Led Brief Intervention |
| Intervention |
Nurse Led Brief Intervention |
The intervention of this study will be the Nurse Led Brief Intervention (NLBI), which will be provided to the experimental group along with routine care, while the control group will receive only standard care. The NLBI will be based on the WHO-recommended 5A (Ask, Advise, Assess, Assist, Arrange) and 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) framework. It will consist of two sessions: the first will be a 30-minute counseling session in which participants will be identified, their tobacco dependence and readiness to change will be assessed, they will be given personalized advice, assisted in developing a quit plan using the STAR method, and follow-up arrangements will be made. For those not ready to quit, motivational strategies using the 5R will be applied. The second session will be an 5-minute video-based awareness program that will highlight the harmful effects of smokeless tobacco, the benefits of quitting, and coping strategies for withdrawal. Follow-up support will be provided through telephonic reminders on the 6th, 13th, and 29th day, and participants will be reassessed for dependence and readiness to change behavior on the 7th, 14th, and 30th day after the first session. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18–60 years using smokeless tobacco for six months or more.
2. Willing to participate in the study.
3. Who can understand Hindi or English Language.
|
|
| ExclusionCriteria |
| Details |
1.Individuals who are diagnosed with psychiatric illness or oral cancer.
2.Those who are currently enrolled in any other tobacco cessation program.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of a Nurse-Led Brief Intervention (NLBI) in reducing smokeless tobacco dependence and enhancing readiness to change behavior among individuals using smokeless tobacco |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/10/2025 |
| 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="1"
Months="0"
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
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Brief Summary
|
Aim: To evaluate the effectiveness of a nurse-led brief intervention on dependence and readiness to change behavior among individuals using smokeless tobacco attending the dental OPD at AIIMS, Jodhpur. Objectives: - To assess and compare the baseline level of dependence and readiness to change behavior among experimental and control group individuals using smokeless tobacco.
- To evaluate the effectiveness of a nurse-led brief intervention on reducing dependence and enhancing readiness to change behavior among experimental and control group individuals using smokeless tobacco.
- To find out the correlation between dependence and readiness to change behavior among individuals using smokeless tobacco.
- To determine the association between dependence and readiness to change behavior with their selected socio-demographic variables among individuals using smokeless tobacco.
Hypothesis: - H0 (Null Hypothesis): There will be no significant difference in dependence and readiness to change behavior scores between the experimental and control groups at a 0.05 level of significance.
- H1 (Alternative Hypothesis): The nurse-led brief intervention will significantly reduce dependence and improve readiness to change behavior among the experimental group compared to the control group at a 0.05 level of significance.
|