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

NCT07013084 | Completed

• 1 other identifier: C202005128
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation

Keywords

smoking cessation; virtual reality; outpatient

Outcome Measures

Primary Outcomes (4)

• smoking status indicator1

  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

  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

  Nicotine dependence was measured using the FTND.

  From enrollment to the end of intervention at 12 weeks

• smoking status indicator4

  exhaled CO levels were measured using a handheld CO monitor

  From enrollment to the end of intervention at 12 weeks

Study Arms (2)

3D VR smoking cessation intervention

EXPERIMENTAL

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

comparison group

NO INTERVENTION

no 3D VR smoking cessation program intervention

Interventions

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.

3D VR smoking cessation intervention

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan Normal University: lead
• Tri-Service General Hospital: collaborator

Study Sites (1)

Tri-Service General Hospital SongShan Branch ,Taipei,Taiwan

Taipei, Taiwan

Location

Related Publications (23)

• Chun HR, Cheon E, Hwang JE. Systematic review of changed smoking behaviour, smoking cessation and psychological states of smokers according to cigarette type during the COVID-19 pandemic. BMJ Open. 2022 Jun 14;12(6):e055179. doi: 10.1136/bmjopen-2021-055179.

  PMID: 35701057 RESULT

• Keijsers M, Vega-Corredor MC, Tomintz M, Hoermann S. Virtual Reality Technology Use in Cigarette Craving and Smoking Interventions (I "Virtually" Quit): Systematic Review. J Med Internet Res. 2021 Sep 17;23(9):e24307. doi: 10.2196/24307.

  PMID: 34533471 RESULT

• Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. Comparative effectiveness of the nicotine lozenge and tobacco-free snuff for smokeless tobacco reduction. Addict Behav. 2013 May;38(5):2140-5. doi: 10.1016/j.addbeh.2013.01.023. Epub 2013 Feb 4.

  PMID: 23454876 RESULT

• Tonnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur Respir J. 2012 Sep;40(3):548-54. doi: 10.1183/09031936.00155811. Epub 2012 Feb 9.

  PMID: 22323576 RESULT

• Caponnetto P, Cibella F, Mancuso S, Campagna D, Arcidiacono G, Polosa R. Effect of a nicotine-free inhalator as part of a smoking-cessation programme. Eur Respir J. 2011 Nov;38(5):1005-11. doi: 10.1183/09031936.00109610. Epub 2011 May 12.

  PMID: 21565921 RESULT

• Ward KD, Asfar T, Al Ali R, Rastam S, Weg MW, Eissenberg T, Maziak W. Randomized trial of the effectiveness of combined behavioral/pharmacological smoking cessation treatment in Syrian primary care clinics. Addiction. 2013 Feb;108(2):394-403. doi: 10.1111/j.1360-0443.2012.04048.x. Epub 2012 Nov 19.

  PMID: 22882805 RESULT

• Karekla M, Savvides SN, Gloster A. An Avatar-Led Intervention Promotes Smoking Cessation in Young Adults: A Pilot Randomized Clinical Trial. Ann Behav Med. 2020 Oct 1;54(10):747-760. doi: 10.1093/abm/kaaa013.

  PMID: 32383736 RESULT

• Goldenhersch E, Thrul J, Ungaretti J, Rosencovich N, Waitman C, Ceberio MR. Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence. J Med Internet Res. 2020 Jul 29;22(7):e17571. doi: 10.2196/17571.

  PMID: 32723722 RESULT

• Pericot-Valverde I, Secades-Villa R, Gutierrez-Maldonado J. A randomized clinical trial of cue exposure treatment through virtual reality for smoking cessation. J Subst Abuse Treat. 2019 Jan;96:26-32. doi: 10.1016/j.jsat.2018.10.003. Epub 2018 Oct 16.

  PMID: 30466545 RESULT

• Guo JL, Liao JY, Chang LC, Wu HL, Huang CM. The effectiveness of an integrated multicomponent program for adolescent smoking cessation in Taiwan. Addict Behav. 2014 Oct;39(10):1491-9. doi: 10.1016/j.addbeh.2014.05.009. Epub 2014 May 28.

  PMID: 24949950 RESULT

• Borrelli B, Rueras N, Jurasic M. Delivery of a smoking cessation induction intervention via virtual reality headset during a dental cleaning. Transl Behav Med. 2021 Feb 11;11(1):182-188. doi: 10.1093/tbm/ibz144.

  PMID: 31665495 RESULT

• Giovancarli C, Malbos E, Baumstarck K, Parola N, Pelissier MF, Lancon C, Auquier P, Boyer L. Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial. Trials. 2016 Feb 19;17:96. doi: 10.1186/s13063-016-1224-5.

  PMID: 26892001 RESULT

• Park CB, Choi JS, Park SM, Lee JY, Jung HY, Seol JM, Hwang JY, Gwak AR, Kwon JS. Comparison of the effectiveness of virtual cue exposure therapy and cognitive behavioral therapy for nicotine dependence. Cyberpsychol Behav Soc Netw. 2014 Apr;17(4):262-7. doi: 10.1089/cyber.2013.0253. Epub 2014 Feb 20.

  PMID: 24555521 RESULT

• Bordnick PS, Traylor AC, Carter BL, Graap KM. A Feasibility Study of Virtual Reality-Based Coping Skills Training for Nicotine Dependence. Res Soc Work Pract. 2012 May;22(3):293-300. doi: 10.1177/1049731511426880.

  PMID: 25484549 RESULT

• Pericot-Valverde I, Garcia-Rodriguez O, Gutierrez-Maldonado J, Ferrer-Garcia M, Secades-Villa R. Evolution of smoking urge during exposure through virtual reality. Stud Health Technol Inform. 2011;167:74-9.

  PMID: 21685645 RESULT

• Gamito P, Oliveira J, Baptista A, Morais D, Lopes P, Rosa P, Santos N, Brito R. Eliciting nicotine craving with virtual smoking cues. Cyberpsychol Behav Soc Netw. 2014 Aug;17(8):556-61. doi: 10.1089/cyber.2013.0329. Epub 2014 Mar 24.

  PMID: 24660864 RESULT

• Acker J, MacKillop J. Behavioral economic analysis of cue-elicited craving for tobacco: a virtual reality study. Nicotine Tob Res. 2013 Aug;15(8):1409-16. doi: 10.1093/ntr/nts341. Epub 2013 Jan 15.

  PMID: 23322768 RESULT

• Garcia-Rodriguez O, Weidberg S, Gutierrez-Maldonado J, Secades-Villa R. Smoking a virtual cigarette increases craving among smokers. Addict Behav. 2013 Oct;38(10):2551-4. doi: 10.1016/j.addbeh.2013.05.007. Epub 2013 May 23.

  PMID: 23793042 RESULT

• Gamito P, Oliveira J, Baptista A, Morais D, Lopes P, Saraiva T, Rosa P, Santos N, Soares F, Sottomayor C, Barata F. Nicotine craving: ERPs correlates after VR exposure to smoking cues. Stud Health Technol Inform. 2012;181:78-82.

  PMID: 22954832 RESULT

• Ramon JM, Nerin I, Comino A, Pinet C, Abella F, Carreras JM, Banque M, Baena A, Morchon S, Jimenez-Muro A, Marqueta A, Vilarasau A, Bullon R, Masuet-Aumatell C. A multicentre randomized trial of combined individual and telephone counselling for smoking cessation. Prev Med. 2013 Sep;57(3):183-8. doi: 10.1016/j.ypmed.2013.05.014. Epub 2013 Jun 1.

  PMID: 23732247 RESULT

• Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, Rodgers A, Cairns J, Kenward MG, Roberts I. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011 Jul 2;378(9785):49-55. doi: 10.1016/S0140-6736(11)60701-0.

  PMID: 21722952 RESULT

• Morris CD, Waxmonsky JA, May MG, Tinkelman DG, Dickinson M, Giese AA. Smoking reduction for persons with mental illnesses: 6-month results from community-based interventions. Community Ment Health J. 2011 Dec;47(6):694-702. doi: 10.1007/s10597-011-9411-z. Epub 2011 May 10.

  PMID: 21556784 RESULT

• Reitzel LR, McClure JB, Cofta-Woerpel L, Mazas CA, Cao Y, Cinciripini PM, Vidrine JI, Li Y, Wetter DW. The efficacy of computer-delivered treatment for smoking cessation. Cancer Epidemiol Biomarkers Prev. 2011 Jul;20(7):1555-7. doi: 10.1158/1055-9965.EPI-11-0390. Epub 2011 May 25.

  PMID: 21613389 RESULT

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 10, 2025
• Study Start: October 12, 2020
• Primary Completion: May 23, 2023
• Study Completion: December 4, 2023
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)