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临床试验/CTRI/2024/09/074352
CTRI/2024/09/074352已完成不适用

A Randomized Controlled Trial Of The Feasibility And Initial Effectiveness Of Yogic Interventions In Tertiary Cancer Care For Tobacco Cessation: Pilot Study

NA1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
NA
入组人数
110
试验地点
1
主要终点
The study will assess the practicality and acceptability of implementing yogic interventions in a tertiary cancer care setting, including factors such as patient and healthcare provider engagement, program adherence, and any challenges encountered during the trial.

研究概览

简要总结

**Aim-**To compare the acute impact of breathing exercises based on yogic intervention along with Tobacco cessation counselling on cravings in abstaining from tobacco ( smoking and smokeless) with Standard Tobacco cessation counselling only.

PRIMARY OBJECTIVE:

To compare the efficacy of the standard TCC and the combination of TCC+Yogic Intervention on cravings in abstaining from tobacco ( smoking and smokeless).

SECONDARY OBJECTIVES:

To evaluate the impact of breathing exercises based on yogic intervention on cravings in abstaining from tobacco( smoking and smokeless).

To assess the level of nicotine addiction in smokers using the Fagerstrom Addiction Scale, which is a widely accepted and validated tool for measuring addiction to smokers and smokeless tobacco.

To evaluate the Mood and Physical Symptoms Scale is a self-report measure that assesses an

individual’s mood and physical symptoms over a specified period, typically the past 24 hours.

To evaluate changes in stress levels, mood, and mindfulness as potential mediators through 3Hz frequency of the intervention’s impact on tobacco cessation.

Patients referred to Preventive from TCC

Convenience sampling method as per  inclusion and exclusion criteria

Both Group-Potential Participants  attend  orientation and complete Pre test questions Fagerstrom and MPSS(Mood and physical symptoms scale)

Both  Group- TCC intervention routine session

Experimental  group- Participants Involving Technique 10 Deep Breaths When Craving Tobacco  Only

Experimental group-  20 min of 3HZ frequency music using app (morning & before sleep).

Experimental group- Weekly one phone call to participants for 6 weeks (Six phone calls)

Experimental group- During each phone call MPSS scale assessment will be done and Post test after six weeks.

Expected Output

Feasibility: The study will assess the practicality and acceptability of implementing yogic interventions in a tertiary cancer care setting, including factors such as patient and healthcare provider engagement, program adherence, and any challenges encountered during the trial.

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
19.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Current Tobacco Users (smoker or Smokeless Tobacco) Willingness to participate in the study.

排除标准

  • Severe medical conditions contraindicating yoga practice Cognitive impairment or inability to provide informed consent.

结局指标

主要结局

The study will assess the practicality and acceptability of implementing yogic interventions in a tertiary cancer care setting, including factors such as patient and healthcare provider engagement, program adherence, and any challenges encountered during the trial.

时间窗: 6 MONTH

次要结局

  • Initial Effectiveness: The study will evaluate the immediate impact of yogic interventions on tobacco cessation outcomes, such as:(Quit rates: The proportion of participants who successfully quit smoking or using tobacco products during the trial period.)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Jyotiben Somabhai Patel

Tata Memorial Hospital

研究点 (1)

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