The Effects of Electronic Cigarette and Traditional Cigarette

NCT07131891 | Completed

• 1 other identifier: 6040102411- Cigarette
• Study Type: observational
• Target: 533
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate and compare the effects of traditional cigarette and e-cigarette consumption habits on sleep quality, fatigue, mental health and quality of life.

Conditions

Cigarette Addiction

Keywords

electronic cigarette; traditional ciagrette; Sleep Quality; Fatigue; Mental Health

Outcome Measures

Primary Outcomes (2)

• Fatigue Severity Scale

  Individuals' fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The scale consists of 9 questions. Participants are questioned about their level of fatigue over the past week. Questions are scored from 1 to 7. The Likert-type scale is used, with 1 point representing "strongly disagree" and 7 points representing "strongly agree," with higher scores indicating greater agreement. A net score is obtained by calculating the arithmetic mean of all questions. The highest possible score is 7. Scores of 4 and above indicate pathological fatigue. The validity and reliability study of the FSS has been conducted in the Turkish language.

  From enrollment to the end of the assessment period at 2 hours

• Jenkins Sleep Scale

  The Jenkins Sleep Scale consists of four questions that assess sleep problems over a 4-week period. Each question is scored from 0 to 5. The total score ranges from 0 to 20 and indicates increasing sleep disturbance.

  From enrollment to the end of the assessment period at 2 hours

Secondary Outcomes (3)

• Depression, Anxiety, and Stress Scale (DASS 21)

  From enrollment to the end of the assessment period at 2 hours

• Epworth Sleepiness Scale

  From enrollment to the end of the assessment period at 2 hours

• Short Form-36

  From enrollment to the end of the assessment period at 2 hours

Study Arms (4)

Electronic cigarette

Electronic cigarette users

Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36

Traditional cigarette

Traditional cigarette users

Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36

Dual

Both electronic and traditional cigarette users

Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36

Control

Those who do not use any tobacco products, whether electronic or traditional

Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36

Interventions

Fatigue Severity Scale OTHER

Individuals' fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The scale consists of nine questions, and participants are asked about their fatigue level over the past week. Questions are scored from 1 to 7 using a Likert-type scale, where 1 corresponds to "strongly disagree" and 7 to "strongly agree," with higher scores indicating greater agreement. The total score is calculated by taking the arithmetic mean of all items, with the highest possible score being 7. Scores of 4 and above indicate pathological fatigue. The validity and reliability of the FSS in Turkish have been previously established.

Control; Dual; Electronic cigarette; Traditional cigarette

Depression, Anxiety and Stress Scale-21 OTHER

The 21-item Depression, Anxiety, and Stress Scale (DASS-21) will be administered to assess individuals' levels of depression, anxiety, and stress. The original scale was developed by Lovibond with 42 items. Subsequently, Brown et al. validated a shorter form for the same purpose and created the 21-item DASS-21. The Turkish adaptation of the DASS-21 was conducted by Yılmaz et al. The scale measures three subscales-depression, anxiety, and stress-consisting of seven items each. It is a 4-point Likert-type scale, with 0 indicating "Does not apply to me," 1 "Applies to me somewhat," 2 "Generally applies to me," and 3 "Applies to me completely." All items are scored positively, and each subscale is categorized as normal, mild, moderate, severe, or very severe.

Also known as: DASS-21

Control; Dual; Electronic cigarette; Traditional cigarette

Jenkins Sleep Scale OTHER

The Jenkins Sleep Scale consists of four questions that assess sleep problems over a four-week period. Each question is scored from 0 to 5, resulting in a total score ranging from 0 to 20, with higher scores indicating greater sleep disturbances.

Control; Dual; Electronic cigarette; Traditional cigarette

Epworth Sleepiness Scale OTHER

The Epworth Sleepiness Scale (ESS) was developed to assess daytime sleepiness. It consists of eight items, each scored from 0 to 3, yielding a total score ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. The Turkish version of the scale was validated for reliability and accuracy by İzci et al. in 2008..

Control; Dual; Electronic cigarette; Traditional cigarette

Short Form-36 OTHER

Quality of life will be assessed using the Turkish version of the Short Form-36 (SF-36). The SF-36 assesses quality of life under eight subscales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each subscale are calculated separately, ranging from 0 to 100, with higher scores indicating better health status. A total score is not calculated.

Control; Dual; Electronic cigarette; Traditional cigarette

Eligibility Criteria

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

Study Population

Male and female individuals between the ages of 18-65

You may qualify if:

• Male and female individuals between the ages of 18-65

Sponsors & Collaborators

• Atılım University: lead

Study Sites (1)

Atılım University

Ankara, Ankara, 06830, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vaping; Sleep Initiation and Maintenance Disorders; Fatigue; Psychological Well-Being

Condition Hierarchy (Ancestors)

Smoking; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Seval Yılmaz, PhD

  Atılım University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: March 30, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)