Brief intervention for tobacco addiction in addition to standard of care for pain relief in chronic pancreatitis: A parallel group, superiority, randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Difference in Izbicki pain score between the two intervention arms at 6 months
研究概览
简要总结
RationaleBrief intervention for tobacco cessation is a non-pharmacologic therapy for helping those addicted quit tobacco more effectively than just a usual advice from physician and is recommended form of counselling as per National Tobacco Control Program (NTCP) of India. Most guidelines strongly recommend tobacco cessation for pain relief in chronic pancreatitis (CP). Despite this the role of tobacco cessation in pain control in CP has not been explored prospectively.
NoveltyAddition of brief intervention to standard of care for pain management in patients with CP with active tobacco intake will not only provide better pain relief but also align with the NTCP goal of integrating tobacco cessation services with existing infrastructure in gastroenterology outpatient setting.
Objectives: 1) Efficacy of brief intervention(I) for tobacco addiction in addition to standard of care(C) for pain relief (O) in patients with chronic pancreatitis and active tobacco intake (P).2)Efficacy of brief intervention for tobacco addiction in addition to standard of care for abstinence among patients with chronic pancreatitis and active tobacco intake.
MethodsInvestigator-initiated parallel group, superiority-framework, randomized-controlled trial with an allocation ratio of 1:1. Intervention-arm A will receive brief intervention by a psychiatrist along with standard-of-care for pain relief in CP. Control-arm B will receive only standard-of-care of pain relief in CP which includes routine advice to quit tobacco.
Expected outcomesPain relief as assessed on Izbicki scale as well as tobacco abstinence rates will be assessed among the two groups. The results will help consolidate the NTCP goals.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Chronic pancreatitis with active tobacco intake (more than 1 cigarette/bidi/pack of gutkha/khaini per day more than 6 months)
- •Age more than 18 years
- •Those who give informed consent.
排除标准
- •1.Patients with chronic pancreatitis with no tobacco intake or less than 1 bidi/cigarette/pack of khaini/guthka per day) 2.Pancreatic cancer 3.Mass-forming chronic pancreatitis 4.Pre-diagnosed psychiatric comorbidities 5.Pregnancy 6.Patients with chronic pancreatitis and symptomatic peptic ulcer disease/biliary stricture or pseudocyst requiring drainage.
- •7.Patients with non-dilated pancreatic duct and stones filling the pancreatic duct till body-tail region.
结局指标
主要结局
Difference in Izbicki pain score between the two intervention arms at 6 months
时间窗: Difference in Izbicki pain score between the two intervention arms at 6 months
次要结局
- Proportion of patients with self-reported abstinence(6 months)
- Proportion of patients with more than 50% decline in tobacco intake(6 months)
- Proportion of patients with complete pain relief (Izbicki score less than 10)(6 months)
- Proportion of patients with partial pain relief (Izbicki score more than 10 but more than 25% decline)(6 months)
- Proportion of patients abstinent as per Russell standard(6 months)
- Time to recidivism from the quit date(follow up of six months)
研究者
Anshuman Elhence
Sanjay Gandhi Post Graduate Institute of Medical Sciences