To compare the effectiveness of using nicotine chewing gum with behavioral counselling versus doing yoga with behavioral counselling in quitting tobacco among Delhi government bus drivers: Cluster Randomized Trial

Completed

Conditions: Nicotine dependence,

Registration Number: CTRI/2020/04/024462

Lead Sponsor: Shristy Sharma

Brief Summary: The tobacco epidemics is one of the biggest public health threats the world has ever faced. According to the reports of WHO , tobacco is the single greatest cause of the preventable deaths globally. It is estimated that there are more than one billion current tobacco users in the world, of whom 80% live in low and middle income countries. in 2015 11.5% of the global deaths were attributed to tobacco use worldwide, of which 52.5% took place in the four countries (China, India, USA and Russia) . Unlike developed countries, where behavioral therapies and/ or pharmacotherapy is provided at little or no cost to patients, support services are very limited for quitting tobacco in India.it has been estimated that two-third of the worldâ€™s population seeks healthcare from sources other than those providing treatment with the allopathic system of medicine. In India complementary alternative medicine therapies which are scientifically appropriate and culturally acceptable like Ayurveda, Yoga and Naturopathy, Unani-tibbi, Siddha and Homeopathy, have been practiced since a long time. considering the withdrawal symptoms of nicotine, among these therapies a promising and affordable option in context of India is the use of Yogic exercises. It is one of the traditional method to achieve good physical and mental health and thus compliance of the patients with this method of tobacco cessation is expected to be high.

Among these employees, bus drivers form an important group belonging to low-medium socioeconomic strata. they are exposed to high level of work demands. And hence more prone to the habit of tobacco consumption. Thus yoga may help in such low-medium socioeconomic strata in quitting the tobacco consumption habit.

Thus this study aim to assess and compare the effectiveness of yoga and behavioral counselling versus nicotine replacement therapy with behavioral counselling among Delhi Government Bus Drivers.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 140

Inclusion Criteria

A daily smoke/ smokeless/ mixed form of tobacco users 2.
Those who will give consent and are able to read and write local language 3.
Patients having medium dependence score according to fagerstrom scale for smoking and modified fagerstrom scale for smokeless tobacco.

Exclusion Criteria

1 Participants not willing to participate.
2 Participants who are completely edentulous.
3 Participants suffering from TMJ problems.
4 Participants practicing yoga regularly.
5 Participants who have used/ using nrt or experienced side-effects due to nrt.
6 Participants who are medically compromised in which practicing yoga is contraindicated.
7 Participants with dental emergency.
8 Participants who consume alcohol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of two methods on the basis of quit status; quit reduction and status quo. To assess and compare the biochemically verified urine cotinine levels using qualitative test at different time intervals among both group	0 day, 1st week, 1st month, 3rd month, 6th month

Secondary Outcome Measures

Name	Time	Method
To assess and compare knowledge, attitude and practice regarding tobacco cessation and its ill effects	To measure oral health status of bus drivers

Trial Locations

Locations (1): RAJGHAT DEPOT 1 & 2
🇮🇳
Central, DELHI, India
RAJGHAT DEPOT 1 & 2
🇮🇳Central, DELHI, India
SHRISTY SHARMA
Principal investigator
8860890417
shristysharma9@gmail.com