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

June 5, 2025 updated by: National Taiwan Normal University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Tri-Service General Hospital SongShan Branch ,Taipei,Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D VR smoking cessation intervention
The program consists of five sequential VR modules, each structured as an interactive game scenario targeting specific aspects of smoking behavior and cessation motivation.
Behavioral: 3D VR smoking cessation program
Participants in the experimental group engaged with the VR system using a head-mounted display, allowing for full immersion in the virtual environment.
No Intervention: comparison group
no 3D VR smoking cessation program intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of intervention at 12 weeks
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
From enrollment to the end of intervention at 12 weeks
smoking status indicator3
Time Frame: From enrollment to the end of intervention at 12 weeks
Nicotine dependence was measured using the FTND.
From enrollment to the end of intervention at 12 weeks
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
From enrollment to the end of intervention at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan Normal University

Collaborators

Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

December 4, 2023

Study Registration Dates

First Submitted

May 26, 2025

First Submitted That Met QC Criteria

June 5, 2025

First Posted (Actual)

June 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C202005128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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