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临床试验/NCT04313738
NCT04313738已完成不适用

Effects of Home-Based Nursing Interventions Performed in Accordance With The Transtheoretical Model on Smoking Cessation in Patients With The Chronic Obstructive Pulmonary Disease: Randomised Controlled Trial

Dokuz Eylul University0 个研究点目标入组 80 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Processes of Change (POC) scale

研究概览

简要总结

Background: The aim of this study is to evaluate the efficiency of nursing intervention based on smoking cessation transtheoretical model in patients with COPD who smoke Method: Experimental design was used in the study. Thirty-three patients in the study group were completed with 35 chronic obstructive pulmonary disease patients in the control group. Sociodemographic characteristics data form, Fagerstrom Nicotine Dependency Test, Transteoretic Model Decision Making Scale, Self-efficacy Scale, Change Stages Scale and Behavior Modification Scale were used as data collection form. In the analysis of the data, the significance test of the difference between the two means, the significance test of the difference between two peers, the two-ratio test, Chi square, Mann Withney U test and Wilcoxon test were used.

Results: Decision-making subscale scores, self-efficacy score scores, and behavior modification methods subscale scores showed significant increases (p<.05) in the decision-making subscale of the patients in the experimental group after the home nursing interventions (p<.05). While there was a significant improvement in the change stages, 9 patients in the experimental group and 2 patients in the control group had left the cigarette but the difference between them was significant (p<.05).

What does this paper contribute?

  • Nursing interventions with home visits based on transtheoretical model supplied to quit smoking of patients
  • The nursing interventions with home visits based on transtheoretical model contributed positively to behavioral change in patients' smoking cessation.

详细描述

Aim of the study The present study was aimed at investigating the effects of nursing interventions on the outcomes of smoking cessation in patients with COPD who smoke.

Study design and setting The study had a single-blind, randomized controlled experimental design. To avoid bias, the participants were not told whether they were in the experimental or the control group. The conceptual structure of the study is given in Figure 1. This randomized clinical trial was based on the guidelines proposed by the Consolidated Standart of Reporting Trials-CONSORT 2010 (Supplementary file 1). The study was conducted between January 2016 and November 2017 at hospital and at homes of the patients with COPD enrolled in a public special branch hospital

Randomization An intervention group and a control group formed by using the research randomizer software. The program used random numbers to select participants and randomly assign them to the experimental or control group (600 participants were assigned to each group). Homogeneity test showed no significant difference between the measures of the groups in table 1 (p>.05).

Blinding of data collectors and the statistician was implemented in this randomized blinded study. Another researcher who did not know the group assignments coded the data in the computer. After statistical analysis was conducted and research report was written, asisstant researcher explained the codes for experimental and control group. Therefore, blinding of the collectors, statistical analysis, and report writing was provided.

Study outcomes, The tools used to collect the data were as follows: Sosyodemographic characteristics questionnaire, Fagerström Test for Nicotine Dependence (FTND) and the components of the Transtheoretical model (Stages of Change (SOC) scale, Processes of Change (POC) scale, Self-Efficacy (SE) scale and Decisional Balance (DB) scale. In addition, measurements were performed using the spirometry available in the hospital where data were collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The study had a single-blind, randomized controlled experimental design. To avoid bias, participants were not told whether they were in the experimental or the control group

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study
  • Being diagnosed with COPD
  • Being >40 years old
  • Being a smoker currently
  • Not having a physical or mental problem preventing the person from filling in the questionnaires to be used in the study and from using telephone
  • Using a mobile phone that is available at all times
  • Living in the city center of Samsun, a city on the north coast of Turkey
  • Not receiving any smoking cessation treatment at the time of the study
  • Not having medical contraindication preventing spirometric evaluation

排除标准

  • Patients with exacerbations in the last two months
  • Having receiving smoking cessation treatment
  • Exclusion Criteria for those already included in the study;
  • Not completing the home visits process
  • Agreeing to participate in the study but then withdrawing from the study for any reason
  • Being diagnosed with lung cancer

结局指标

主要结局

Processes of Change (POC) scale

时间窗: 6 mounth

The scale developed by Prochaska et al. (1988) includes 30 items questioning the cognitive processes (15 items) and behavioral processes (15 items). Each process contains five sub-dimensions. It is a five-point Likert type scale. The options determine which methods an individual uses in behavior change. In the present study, Cronbach's Alpha values ranged between 0.61 and 0.92.

Stages of Change (SOC) scale

时间窗: 6 mounth

Prochaska and Diclemente (1983) explained smoking cessation through the gradual change process and developed the questions of change. Accordingly, people select one of the following corresponding to his/her situation: Precontemplation: I do not consider quitting smoking in the next six months. Contemplation: I am planning to quit smoking in the next six months. Preparation: I am planning to quit in the next 30 days. Action: I quit smoking less than six months ago. Maintenance: I have not been smoking for more than six months.

Decisional Balance (DB) scale

时间窗: 6 mounth

The scale developed by Velicer et al. (1985) has 12 items in two sub-dimensions: Pros of change (6 items) and Cons of change (6 items). The Cronbach's Alpha value was 0.71 and 0.85 in the present study. The items of the scale are rated on a five-point likert type scale. The minimum and maximum possible scores to be obtained from the scale are 6 and 30 respectively.

Fagerström Test for Nicotine Dependence

时间窗: 6 mounth

The test developed by Fagerström, Heatherton and Kozlowski in 1992 includes 6 items each of which is rated on a different scale. A total score ranging from 0 to 4 indicates low nicotine dependence, from 5 to 6 indicates moderate dependence and from 7 to 10 indicates high independence. It was adapted by Uysal et al. (2004). Cronbach's alpha value was 0.79 in the present study.

Self-Efficacy (SE) scale

时间窗: 6 mounth

The scale developed by Velicer et al. (1990) measures the degree of confidence an individual has in maintaining non-smoking behavior in situations triggering smoking. It was adapted by Koyun, Bodur and Eroğlu (2015). Cronbach's alpha values of was 0.93 in the present study. The scale consists of eight items rated on a 5-point Likert type scale. The lowest and highest possible scores to be obtained from the scale are 8 and 40 respectively. The higher the score is the more successful the person is.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Figen Cavusoglu

Assistant Professor

Dokuz Eylul University

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