Effects of Nicotine Dependence on Multidimensional Health Outcomes

Condition(s) studied

Investigational drug(s) / intervention(s)

Comprehensive Clinical Assessment: Participants will undergo a comprehensive clinical assessment including evaluation of nicotine dependence level (Fagerström Test for Nicotine Dependence), respiratory muscle strength (MIP, MEP), functional capacity (6-Minute Walk Test), cognitive function (MoCA), pain (VAS and SF-MPQ), quality of life (SF-36), physical activity level (IPAQ-SF), sleep quality (PSQI), addiction behavior model (SOCRATES), and health beliefs (Health Belief Model Scale). No therapeutic intervention will be administered.

Study summary

Nicotine, a major toxic component of cigarette smoke, together with carbon monoxide (CO), constitutes a significant environmental exposure with systemic effects. Beyond its addictive potential, chronic nicotine exposure may induce inflammation, oxidative stress, tissue hypoxia, and autonomic imbalance, potentially impairing respiratory muscle strength, functional capacity, and overall physical performance. Additionally, nicotine dependence has been associated with sleep disturbances, cognitive dysfunction, altered pain perception, and reduced quality of life.

Although previous studies have examined individual effects of smoking on specific health outcomes, research addressing these multidimensional impacts within a comprehensive framework remains limited. Therefore, this study aims to investigate the relationship between nicotine dependence level and respiratory muscle strength, functional capacity, cognitive functions, pain, quality of life, physical activity level, and sleep quality, in order to provide a more holistic understanding of the clinical consequences of nicotine dependence.

Eligibility

Primary outcome measure(s)

• Assessment of Nicotine Dependence — At baseline
  Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). The test was originally developed by Karl O. Fagerström, and its Turkish validity and reliability study was conducted in 2003. The FTND consists of six items. The total score obtained from participants' responses determines the level of nicotine dependence. Scores of 0-2 indicate very low dependence, 3-4 low dependence, 5 moderate dependence, 6-7 high dependence, and 8-10 very high dependence. This evaluation provides an important criterion for determining the need for intervention related to cigarette dependence.
• Maximal Inspiratory Pressure (MIP) — At baseline
  Maximal inspiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
• Maximal Expiratory Pressure (MEP) — At baseline
  Maximal expiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
• Assessment of Functional Capacity — At baseline
  Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform the test in a 30-meter corridor. Two tests will be conducted, and the longer walking distance will be used for analysis. Rest periods will be permitted and included in the total test duration. The walked distance will be expressed in meters (m). Predicted walking distance values will be calculated using standard reference equations.
• Assessment of Cognitive Functions — At baseline
  Cognitive functions will be evaluated using the Montreal Cognitive Assessment (MoCA). MoCA is a comprehensive screening tool that assesses attention, concentration, memory, language skills, executive functions, visuospatial abilities, abstraction, calculation, and orientation. The total score ranges from 0 to 30, and scores of 21 and above will be considered indicative of normal cognitive function. The Turkish version has established validity and reliability.
• Assessment of Pain — At baseline
  Pain will be evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ) to assess both qualitative and quantitative aspects of pain. The scale consists of three sections. The first section includes 15 descriptors (11 sensory and 4 affective). Participants rate each descriptor from 0 (none) to 3 (severe). The second section evaluates overall pain intensity using a visual comparison scale. The third section assesses present pain intensity on a scale from 0 (no pain) to 5 (unbearable pain). Scores will be analyzed separately as sensory, affective, and total pain scores. The Turkish version has demonstrated validity and reliability.
• Assessment of Quality of Life — At baseline
  Quality of life will be assessed using the Short Form-36 (SF-36) Health Survey. This scale evaluates general health status across eight domains: physical functioning, role limitations due to physical problems, social functioning, role limitations due to emotional problems, vitality, pain, mental health, and general health perception. Each domain is scored from 0 to 100, with higher scores indicating better quality of life. The Turkish version has established validity and reliability.
• Assessment of Physical Activity Level — At baseline
  Physical activity level will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). This questionnaire collects information about walking, moderate-intensity activity, vigorous-intensity activity, and sedentary time during the past seven days. It consists of seven items grouped into four sections. Based on participants' responses, weekly physical activity levels will be calculated and classified as low, moderate, or high. Metabolic equivalent (MET) values will be used in the calculation (vigorous activity: 8 METs; moderate activity: 4 METs; walking: 3.3 METs), and weekly MET-minutes will be determined for each activity type.
• Assessment of Sleep Quality — At baseline
  Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale consists of 24 items, 19 of which are self-rated and 5 rated by a bed partner or roommate. It includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored between 0 and 3, yielding a total score ranging from 0 to 21. Items completed by a partner or roommate are not included in the total score calculation. Lower total scores indicate better sleep quality. The Turkish version has demonstrated acceptable reliability.
• Addiction Behavior Model — At baseline
  Addiction behavior will be evaluated using the Stages of Change Questionnaire (SOCRATES). This 19-item self-report scale assesses readiness to change and motivation for treatment. The Turkish version has established validity and reliability.
• Assessment of Health Behaviors — At baseline
  Health behaviors will be assessed using the Health Belief Model Scale (HBM). The Health Belief Model is a psychosocial framework developed to understand health-related behaviors. It examines perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. The Health Belief Model Scale is used to measure these perceptions, and adaptations for smoking cessation behavior are available in Turkey.

Trial sites (1)

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