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Completed

NCT Number: NCT07013084

Study on the Effect of Digital Smoking Cessation Education Intervention on Outpatients

This study aimed to assess the novel approach of an immersive three-dimensional (3D) virtual reality (VR) smoking cessation program and its effectiveness on smoking outpatients

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital SongShan Branch ,Taipei,Taiwan

Taipei, Taiwan

About this study

A randomized controlled trial (RCT) was conducted with 100 outpatients from a smoking cessation clinic in Taiwan. Participants were randomly assigned to either the experimental group (n=50) or the comparison group (n=50) through a coin toss. The experimental group received standard outpatient smoking cessation services in combination with an immersive 3D VR smoking cessation program, while the comparison group received only standard outpatient services. The VR program included five interactive modules that used immersive scenarios to simulate smoking-related cues and provide educational content, employing cognitive-behavioral techniques and practicing coping strategies to promote behavior change.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • currently receiving outpatient care at the smoking cessation clinic
  • self-reported current tobacco use
  • aged between 20 and 64 years
  • no participation in any smoking cessation intervention within the past 12 months

Exclusion criteria

  • Patients with medical contraindications that could prevent them from engaging with the VR equipment

Treatment and study plan

3D VR smoking cessation program

Behavioral

Participants in the experimental group engaged with the VR system using a head-mounted display, allowing for full immersion in the virtual environment.

Primary outcomes

  1. smoking status indicator1

    Time frame: From enrollment to the end of intervention at 12 weeks

    Participants reported the number of days they smoked in the past 30 days

  2. smoking status indicator2

    Time frame: From enrollment to the end of intervention at 12 weeks

    Participants reported the average number of cigarettes consumed per day in the past 30 days

  3. smoking status indicator3

    Time frame: From enrollment to the end of intervention at 12 weeks

    Nicotine dependence was measured using the FTND.

  4. smoking status indicator4

    Time frame: From enrollment to the end of intervention at 12 weeks

    exhaled CO levels were measured using a handheld CO monitor

Sponsors and collaborators

Lead sponsor

National Taiwan Normal University

Other

Collaborators

  • Tri-Service General Hospital (TSGH)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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