NCT04524533

VR Smoking Cessation During a Dental Hygiene Visit

Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment. Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group

Detailed description

Approximately 400 patients who have a scheduled prophylaxis, root planing and scaling dental appointment at the BUGSDM patient treatment center will be recruited and enrolled in the randomized controlled trial. Participants who complete the baseline survey will be randomized to either the intervention or control group. The intervention group will watch one of two smoking cessation videos during the appointment (depending on readiness to quit), receive a brochure about EBTs for smoking cessation, and participate in a 4-week tailored text message program designed to motivate EBT utilization. After the 4-week text message program, the intervention group will receive monthly assessment text messages for six months. The control group will watch a control video during the appointment, receive the same brochure about EBTs as the intervention group, and participate in an assessment-only 4-week text message program. All videos are approximately 10 minutes long. After the dental clinic appointment, all participants will complete an online questionnaire and begin the 4-week text message program. At the end of the 4-week text message program, and 3 and 6 months later, all participants will complete online questionnaires. Primary Aim 1: To test the efficacy of the intervention vs. control in increasing utilization of EBTs over the course of follow-up (7-months). Hypothesis 1.1: Smokers randomized to the intervention will be more likely to engage with (contact) EBTs. Hypothesis 1.2: Smokers randomized to the intervention will have greater treatment utilization (e.g., more days in the text message program, more days using smoking cessation medication, and more quitline counseling sessions, greater number of EBTs). Secondary Aims: Aim 2: To test the effect of the intervention vs. controls on quit attempts and on motivation to quit. Hypothesis 2: Smokers randomized to the intervention will have more quit attempts and higher motivation to quit. Aim 3: To test the efficacy of the intervention vs controls on biochemically verified abstinence. Hypothesis 3: Smokers randomized to the intervention will have higher quit rates at follow-up. Aim 4: To assess the mechanisms through which the intervention effects occur (social cognitive mediators) and to identify subpopulations for whom intervention effects differ (moderators, e.g., readiness to quit, gender, race/ethnicity). Hypothesis 4: The intervention will directly affect the putative mediators, which will in turn affect EBT utilization. The role of moderators will be exploratory.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	Experimental smoking cessation video	Participants who are randomized to the intervention group will watch an educational video that includes tips on quitting smoking during a dental cleaning. The video is approximately 10 minutes long and tailored to readiness to quit at the time of the dental visit.
BEHAVIORAL	Control video	Participants randomized to the control group will watch a 10 minute video.
OTHER	Brochure of smoking cessation EBTs	All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
BEHAVIORAL	Tailored text message program	Participants randomized to the intervention group will be enrolled in a 4-week tailored text message program which includes assessment questions in addition to text messages geared towards motivating and facilitating EBT utilization for individuals ready to quit smoking and individuals who are not ready to quit smoking.
OTHER	Assessment text messages	Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.

Timeline

• Start date: 2021-01-04
• Primary completion: 2025-03-19
• Completion: 2025-09-01
• First posted: 2020-08-24
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States