Effects of Nicotine Dependence on Multidimensional Health Outcomes

NCT07474623 | Not Yet Recruiting

• 1 other identifier: Nicotine35
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder; Nicotine Dependence, Cigarettes

Keywords

Nicotine Dependence; Respiratory Muscle Strength; Quality of Life

Outcome Measures

Primary Outcomes (11)

• Assessment of Nicotine Dependence

  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.

  At baseline

• Maximal Inspiratory Pressure (MIP)

  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.

  At baseline

• Maximal Expiratory Pressure (MEP)

  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.

  At baseline

• Assessment of Functional Capacity

  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.

  At baseline

• Assessment of Cognitive Functions

  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.

  At baseline

• Assessment of Pain

  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.

  At baseline

• Assessment of Quality of Life

  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.

  At baseline

• Assessment of Physical Activity Level

  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.

  At baseline

• Assessment of Sleep Quality

  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.

  At baseline

• Addiction Behavior Model

  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.

  At baseline

• Assessment of Health Behaviors

  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.

  At baseline

Study Arms (1)

Adult Smokers

OTHER

Adult individuals who use cigarettes will be enrolled in this observational study. Participants will be evaluated for nicotine dependence level using the Fagerström Test for Nicotine Dependence and will undergo assessments of respiratory muscle strength (MIP, MEP), functional capacity (6-Minute Walk Test), cognitive function (MoCA), pain (VAS/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 intervention will be applied.

Other: Comprehensive Clinical Assessment

Interventions

Comprehensive Clinical Assessment OTHER

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.

Adult Smokers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regular cigarette use for at least the past 6 months
• No history of respiratory, cardiovascular, or neurological/psychiatric disease
• No recent history of surgery or trauma that could affect respiratory muscles
• No current acute infection (especially upper or lower respiratory tract infections)

You may not qualify if:

• Presence of chronic respiratory diseases such as COPD or
• History of cardiovascular disease
• Diagnosed neurological or psychiatric disorders
• history of surgery or trauma affecting the respiratory muscles within the last 3 months
• Pregnancy or suspected pregnancy

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ferruh Taşpınar, Prof.Dr.

  İzmir democracy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Taşpınar, Prof.Dr.

CONTACT

+90 506 680 44 26; betul.taspinar@gmail.com

Özge Kuşçu, Pt.

CONTACT

+90553 105 86 54; ozgekuscu26@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: Adult individuals who use cigarettes will be included.

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 16, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

TU (1)