跳至主要内容
临床试验/CTRI/2020/04/024462
CTRI/2020/04/024462已完成不适用

Effectiveness of behavioral counselling with nicotine gum versus behavioral counselling with Yoga on tobacco cessation among Delhi Government Bus Drivers: Cluster Randomized Trial

Shristy Sharma1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年8月21日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
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

研究概览

简要总结

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 world’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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
21.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 0 day, 1st week, 1st month, 3rd month, 6th month

次要结局

  • To assess and compare knowledge, attitude and practice regarding tobacco cessation and its ill effects(To measure oral health status of bus drivers)

研究者

发起方
Shristy Sharma
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验