| CTRI Number |
CTRI/2020/06/026144 [Registered on: 25/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [motivational interviewing technique for smoking cessation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy Of Spouse Assisted Smoking Cessation Intervention Among Smokers. |
|
Scientific Title of Study
|
Evaluation and Comparison Of Effectiveness Of Spouse Assisted Smoking Cessation Intervention Among Smokers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep n |
| Designation |
Post Graduation Student (MDS) |
| Affiliation |
The Oxford Dental College |
| Address |
Department Of Public Health Dentistry, Room No-6, The Oxford Dental College, Bommanahalli,Hosur road, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
09036006055 |
| Fax |
|
| Email |
pradee.n17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shwetha R |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department Of Public Health Dentistry, Room No-6, The Oxford Dental College, Bommanahalli,Hosur road, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9980183218 |
| Fax |
|
| Email |
drshwetha_r@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep n |
| Designation |
Post Graduation Student (MDS) |
| Affiliation |
The Oxford Dental College |
| Address |
Department Of Public Health Dentistry, Room No-6, The Oxford Dental College, Bommanahalli,Hosur road, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
09036006055 |
| Fax |
|
| Email |
pradee.n17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator initiated self sponsorship. The Oxford Dental College,Bommanahalli, Bangalore |
|
|
Primary Sponsor
|
| Name |
Pradeep N |
| Address |
The Oxford Dental College, Bommanahalli, Bangalore |
| 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 |
| Pradeep N |
The Oxford Dental College |
Department Of Public Health Dentistry, Room No-6 Bommanahalli, HOsur road, Bangalore
Bangalore
KARNATAKA |
09036006055
pradee.n17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, THE OXFORD DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
smokers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
motivational interview. |
Smokers in control group receives motivational interview. |
| Intervention |
spouse assisted smoking cessation intervention |
Smokers receives spouse assisted smoking cessation intervention based on motivational interviewing technique. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Smokers more than 21 years and above
Individuals who are willing to quit and their spouses who would participate as a support participant.
|
|
| ExclusionCriteria |
| Details |
Subjects with any systemic disorders.
Individuals who are already enrolled in other cessation programs.
Individuals having psychological, alcohol or drug dependency problems.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare smoking quit rate in study and control group. |
At baseline, 7th day, 3months and 6months interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the reduction in tobacco dependency in study and control groups.
|
At baseline, 7th day, 3months and 6months interval. |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
29/06/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
NEED FOR THE STUDY
Smoking is the primary cause of preventable diseases worldwide.1It poses a serious health threat to smokers and smoking parents are the
major source of second and third hand
smoke exposure for children, infants and other family members, which can be
preventable through health education and motivation.2 Motivational
interviewing(MI) is a promising approach applied to reduce the smoking rates
among smokers effectively and efficiently. Studies have shown that, third party
support plays an important role in the process of smoking cessation along with
MI among smokers.3 Researchers have found that the existence
of a partner or a friend who is specifically supportive of an attempt to stop
smoking predicts success in cessation attempts.4The tailoring counseling style
to motivational levels and support from family members, such as spouses, can help the smoker to
maintain long term abstinence. There are
limited clinical trials assessing family support and smoking cessation,
it is worthwhile to further study the role of family support on smoking
cessation.1Thus the purpose of this
study is to help husbands who smoke, to quit the habit of smoking by educating their non-smoking
spouses. AIM OF THE STUDY:
To evaluate the
effectivenesse of spouse assisted smoking cessation intervention among
individuals with smoking habits. OBJECTIVE OF THE STUDY
1) To evaluate and compare smoking
quit rate in study and control group.
2) To evaluate and compare the reduction
in tobacco dependency in study and control groups.
NULL HYPOTHESIS
There is no difference in the effectiveness of
smoking cessation intervention among smokers
with spouse assisted motivational
interviewing technique.
RESEARCH HYPOTHESIS
There is a difference in effectiveness
of smoking cessation intervention among smokers with
spouse assisted motivational
Interviewing technique.
RESEARCH QUESTION
Is there any difference in
effectiveness of smoking cessation intervention among smokers with spouse assisted motivational interviewing technique?
|