NCT05910203

Brief Summary

Health is a main human right and a need for every human being. However, due to some congenital or acquired reasons, individuals may be disabled and cannot participate in social life at the same level as their normally developing peers. The gradual increase in the world population, the advances in the treatment of chronic diseases and the prolongation of life expectancy at birth, along with the increase in economic, social and psychological problems and deterioration in environmental conditions show that the number of disabled individuals will increase in the future. Diseases caused by the use of tobacco and tobacco products rank first among preventable diseases in the world, and tobacco use is a very important public health problem. Nurses use various models developed as a guide in developing goals for lifestyle change in individuals and in interventions to achieve this. One of the studies they conduct based on the models is smoking cessation. It is believed that the studies to be carried out will strengthen the perceptions of individuals about protecting and improving their health and will guide the way in which the obstacles to smoking cessation can be perceived and resolved more easily. Based on this, it is thought that the smoking cessation study to be carried out by using HBM in visually impaired individuals will draw attention to unhealthy lifestyle behaviors and smoking addiction, which is one of these behaviors. The study was designed experimentally with "pretest-posttest control group". Before and after the planned smoking cessation training given based on HBM, the scores of Fagerström Nicotine Dependence Test and the smoking cessation scale according to HBM and hemoglobin and CO measurement values of the visually impaired individuals will be compared. Statistical package program will be used for coding, statistical analysis and evaluation of the data to be obtained from the study. T-test will be used in independent groups and t-test in dependent groups depending on the distribution features of the data in the statistical analysis. The normality distribution of the data will be evaluated by Wilk's, Kurtosis and Skewness coefficients. In the data distributed normally, non-parametric tests, Kruskal Wallis test or Mann-Whitney test will be used, and parametric tests, dependent and independent groups' t-test in two variables and ANOVA (analysis of variance) will be used in two or more variables.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

April 16, 2023

Last Update Submit

February 5, 2024

Conditions

Keywords

Visually impaired individualsHealth belief modelNursingSmoking

Outcome Measures

Primary Outcomes (3)

  • The effectiveness of smoking cessation education based on the health belief model

    The data of the study; Personal Information Form prepared by the researcher will be collected using Fagerström Nicotine Dependence Test and smoking cessation scale according to the health belief model. Statistical package program will be used in coding, statistical analysis and evaluation of data. In addition to the mean, standard deviation, numbers and percentages will also be used in the evaluation of the data. At the beginning of the study, the scale and test score and hemoglobin and CO measurement values obtained in the 1st, 3rd and 6th months will be compared.

    0.months- 6. months

  • Hemoglobin measurement

    Hemoglobin measurement of the visually impaired individuals included in the study will be measured and their smoking status will be determined and recorded. At the beginning of the study, hemoglobin measurement values obtained in the 1st, 3rd and 6th months will be compared. Hemoglobin will be evaluated in grams per 1 deciliter.

    0.months- 6. months

  • Carbon monoxide (CO) measurement

    Carbon monoxide (CO) measurement of the visually impaired individuals included in the study will be measured and their smoking status will be determined and recorded. At the beginning of the study, CO measurement values obtained in the 1st, 3rd and 6th months will be compared. CO will be measured and recorded in mg/m3 or ppm.

    0.months- 6. months

Study Arms (2)

Health belief model smoking cessation scale

OTHER

Describing the thoughts and behaviors of visually impaired individuals about quitting smoking

Other: The effectiveness of education

Nicotine addiction scale

OTHER

Evaluation of individuals' smoking cessation status

Other: The effectiveness of education

Interventions

Training will be provided on smoking cessation.

Also known as: Quit smoking
Health belief model smoking cessation scaleNicotine addiction scale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being visually impaired
  • Be over 18 years old
  • Demonstrate normal mental and cognitive development
  • Smoking at least 1 cigarette in the last 30 days

You may not qualify if:

  • Be under the age of 18
  • Individuals who do not show normal development mentally and cognitively
  • Non-smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, 68100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

SmokingBlindnessHealth Risk Behaviors

Condition Hierarchy (Ancestors)

BehaviorVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHealth Behavior

Study Officials

  • Funda Tuncer Şahin

    Aksaray University

    STUDY CHAIR

Central Study Contacts

Funda Tuncer Sahin, 1

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The research was designed experimentally with "pretest-posttest control group".
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 16, 2023

First Posted

June 18, 2023

Study Start

December 1, 2023

Primary Completion

January 1, 2024

Study Completion

December 1, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations