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临床试验/CTRI/2018/03/012867
CTRI/2018/03/012867已完成不适用

Effectiveness of Behavioral Counselling with Nicotine Gum versus Behavioral Counselling among patients visiting Tobacco Cessation Clinic in Delhi: a Randomized Clinical Trial.

Dr Neetu1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年10月7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
120
试验地点
1
主要终点
Effectiveness of two methods on the basis of quit status: quit, reduction and status quo.

研究概览

简要总结

Tobacco related diseases have emerged as a major public health in India.Nearly 3000 chemical constituents in smokeless tobacco and about 4000 chemicals in tobacco smoke have been identified of which many are known carcinogens.According to World Health Organization the current smokers across the world are 1.3 billion and 5 million in the world die annually due to smoking.Nearly two-thirds of the world’s tobacco users live in just 10 countries and >40% live in just 2 countries,that is, China and India. India is currently the second largest consumer of tobacco products in the world.Problems related to tobacco in India are very complex because of the relationship between huge burden of tobacco related diseases, deaths, economic interests and also cultural beliefs.

Unfortunately, very few people in India quit tobacco use. Lack of awareness of harm, ingrained cultural attitudes and lack of support for cessation maintains tobacco use in the community. The significant addictive property of nicotine makes quitting difficult and relapse common. Health professionals have received little training, and very few thus carry out proper assessments and interventions among tobacco users. Evidence from the developed countries suggests that brief interventions delivered by diverse health professionals are effective in tobacco cessation. Combining pharmacological approaches with behavioral counselling produces better results than a single strategy. Given the high global morbidity and mortality from tobacco use in India ,there is a need to develop evidence-based, cost-effective interventions for both smoking and smokeless tobacco.

Hence,the present study is planned among tobacco users visiting Tobacco Clinic Clinic to check the effectiveness of tobacco cessation interventions.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • A daily smoker/smokeless/mixed form of tobacco user.
  • Patients reporting to the TCC and found to be tobacco users.
  • Those who will give informed consent and are able to read and write local language.
  • Patients who have medium nicotine dependence score as per Fagerstrom scale for smoking and Modified Fagerstrom scale for smokeless tobacco.

排除标准

  • Patient not willing to participate, uncooperative and are edentulous/having TMJ problems/chewing difficulties and any dental emergencies.
  • Patients who are medically compromised and have diseases which are contraindications for NRT use.
  • Patients/Tobacco users who have not participated in any trial or intervention related to tobacco cessation.
  • Patients who report past usage of NRT (with or without prescription) and have experienced side effects.

结局指标

主要结局

Effectiveness of two methods on the basis of quit status: quit, reduction and status quo.

时间窗: 1st week,2nd week, 3rd week, 3rd month, 6th month

次要结局

  • Sociodemographic and other related factors, Nicotine dependence, Oral health status and Tobacco related Health Literacy.(1st week,2nd week, 3rd week, 3rd month, 6th month)

研究者

发起方
Dr Neetu
申办方类型
Other [personal]

研究点 (1)

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