Efficacy Of Virtual Reality - Assisted Health Education In Smoking Cessation - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- To assess the level of tobacco dependence using the Fagerstrom addiction scale before and
研究概览
简要总结
A randomised controlled study is designed to assess the efficacy of virtual reality-assisted
health education in smoking cessation among smokers visiting tertiary care centres. The tobacco users
of age 18 years to 64 years attending Tobacco Cessation Clinic at Department of Public Health
Dentistry, Tamil Nadu Government Dental College and Hospital satisfying the eligibility criteria are
recruited for the present study. Physically and mentally challenged individuals, subjects currently
using NRT or anti-depressants, those diagnosed with oral cancer, subjects diagnosed with epileptic
conditions and those diagnosed with cardiac conditions are excluded from the study.
A simple random sampling technique is employed to select the desired sample of participants.
The study participants are clearly informed about the purpose of the study by providing patient
information sheet. Written informed consent is obtained from the study participants. Then, the
participants are randomly allocated into study and control groups using a computer-generated random
sequence.
The study group will receive VR-based tobacco cessation interventions along with routine
health education. The control group participants will receive the routine audio-visual assisted health
education for smoking cessation. Both the group participants will receive interventions for a duration
of 15 – 30 minutes in each session. A quit date would be fixed for both study and control group leaving
14 days from the first visit as grace time for reducing tobacco use. The participants are followed up
from the quit date for 1, 3 and 6 months to evaluate the fagerstorm addiction scores, self-reported
continuous tobacco abstinence and point prevalence tobacco abstinence and relapse rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •Current smoking tobacco users aged 18 years to 64 years.
排除标准
- •Physically and mentally challenged individuals.
- •Subjects currently using NRT or anti-depressants.
- •Subjects diagnosed with oral cancer.
- •Subjects diagnosed with epileptic conditions.
- •Subjects diagnosed with cardiac conditions.
结局指标
主要结局
To assess the level of tobacco dependence using the Fagerstrom addiction scale before and
时间窗: At the baseline and after 1 month
after intervention.
时间窗: At the baseline and after 1 month
次要结局
- To evaluate the self-reported tobacco abstinence between VR and(control group.)
- To evaluate the tobacco abstinence using Carbon monoxide breath(analyser between VR & control group.)
研究者
Dr Sudhanish Neelakandan
Tamil Nadu Government Dental College and Hospital