| CTRI Number |
CTRI/2024/07/070545 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Neuro Linguistic Programming to help people quit tobacco |
|
Scientific Title of Study
|
Incorporating Neuro Linguistic Programming in behavior counselling for tobacco cessation A Randomised 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 |
Amrita Bansal |
| Designation |
Post Graduate Student |
| Affiliation |
Government College Of Dentistry,Indore |
| Address |
Department Of Public Health Dentistry, Room number 13 Government College Of Dentistry, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
07024294305 |
| Fax |
|
| Email |
amritabansal96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Gupta |
| Designation |
Associate Professor |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Department Of Public Health Dentistry, Room number13, Government College Of Dentistry, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9752153020 |
| Fax |
|
| Email |
drpuneetgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Gupta |
| Designation |
Associate Professor |
| Affiliation |
Government College of Dentistry, Indore |
| Address |
Department Of Public Health Dentistry, Room number 13 Government College Of Dentistry, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9752153020 |
| Fax |
|
| Email |
drpuneetgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Bansal, Government College Of Dentistry,Indore-452001, M.P India |
|
|
Primary Sponsor
|
| Name |
Dr Amrita bansal |
| Address |
Government College Of Dentistry, Opposite MY Hospital,Indore-452001, MP, India |
| 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 |
| Dr Amrita Bansal |
Government College of Dentistry |
Department of Public Health Dentistry, Room number 13, Opposite MY Hospital, Jaora compound, Ushaganj
Indore
MADHYA PRADESH |
07024294305
amritabansal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government College of Dentistry,Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
tobacco cessation using conventional behavior counselling |
Initial behavior counseling for tobacco cessation focuses on understanding and changing the behaviors and thought patterns that contribute to tobacco use.
counselling is done for 3 months and patient is followed up further for 3 months. |
| Intervention |
tobacco cessation using neuro linguistic programming |
Neurolinguistic Programming (NLP) is a psychological approach that involves analyzing strategies used by successful individuals and applying them to reach personal goals. It relates thoughts, language, and patterns of behavior learned through experience to specific outcomes. In the context of substance abuse counseling, NLP can be a valuable tool for both counselors and clients.
counselling is done for 3 months and patient is followed up for further 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients reporting to the tobacco cessation clinic of the department
2.Patients who are current consumers of tobacco (smoking or smokeless or both)
3.Patients giving informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known psychotic disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| abstinence of tobacco use for a week |
upto six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare NLP and behavioural counselling for Tobacco cessation and to explore factors that influence tobacco cessation
|
upto six months |
|
|
Target Sample Size
|
Total Sample Size="205"
Sample Size from India="205"
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 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="9"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amritabansal96gmail.com].
- For how long will this data be available start date provided 21-04-2025 and end date provided 09-04-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Participants who are regular tobacco users will be assigned into two groups, control group will be given conventional behavioural counselling and study group will be given behavioural counselling incorporating with NLPt techniques for tobacco cessation for 6 months. Patients will be evaluated using the format provided by the dental council of India. Self reported quit will be used to evaluate the effectiveness of the program |