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
2 other identifiers
interventional
440
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedStudy Start
First participant enrolled
January 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 3, 2025
August 1, 2025
4.2 years
August 20, 2020
August 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Utilization of Massachusetts State Quitline
Self-reported use of smoker quitline services validated through objective review of the quitline database (whether participant contacted the quitline, whether a decision to start counseling was made, the type of counseling requested, the number of sessions received, whether a quit date was set, whether nicotine replacement products were requested by participants, and whether nicotine replacement products were sent to participants).
7 months
Utilization of the National Cancer Institute "SmokefreeTXT" service
Self-reported use of SmokefreeTXT validated through objective verification of program interaction (length of program utilization, and engagement with program).
7 months
Utilization of clinic or hospital-based smoking cessation services
Self-reported use of smoking cessation programs offered by clinics or hospitals (whether participant contacted the clinic, whether a decision to start counseling was made, the type of counseling requested, the number of sessions received, whether a quit date was set, whether nicotine replacement products and/or other cessation medications were requested by participants, and whether nicotine replacement products and/or other cessation medications were given to participants).
7 months
Secondary Outcomes (7)
Use of a combination of EBTs
7 months
Quit smoking attempts
7 months
Motivation to quit smoking
7 months
7-day point prevalence smoking abstinence at end-of-treatment
1 month
7-day point prevalence smoking abstinence at end-of-treatment
3 months
- +2 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALParticipants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
Control group
ACTIVE COMPARATORParticipants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
Interventions
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.
Participants randomized to the control group will watch a 10 minute video.
All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
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.
Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.
Eligibility Criteria
You may qualify if:
- Patient of the Boston University, Henry M Goldman School of Dental Medicine treatment center with an upcoming dental hygiene appointment (dental prophylaxis or scaling and root planing)
- Self-reported smoking 100 cigarettes or more (not including e-cigarettes or vaping) in lifetime
- Self-reported smoking any cigarette (not including e-cigarettes or vaping) in the preceding week
- Self-reported cigarettes (not including e-cigarettes or vaping) 'some days', 'most days' or 'every day' in the preceding week
- Is able to understand written and spoken study materials
- Score of 'Never,' 'Rarely' or 'Sometimes' on the validated single-item literacy screener ("How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor, dentist, or pharmacy?")
- Self-reported visual capacity to watch a video as indicated by the score 'Some difficulty' or 'No difficulty' to: "How much difficulty do you have with your vision, even when wearing glasses?"
- Self-reported ability to wear headphones that are inserted partially inside the ear
- Self-reported use of text messaging at least once in the preceding month
- Self-reported access to necessary resources for intervention: Cell phone capable of text messaging
- Live in Massachusetts
- Stated willingness to comply with text message program procedures (receive and respond to text messages for 4-weeks)
You may not qualify if:
- Participation in another treatment or intervention study for smoking cessation or research involving text messaging
- Current use of medications for smoking cessation or smoking reduction (nicotine replacement product, or non-nicotine medications) whether prescribed or not
- Failure to complete the pre-dental clinic appointment procedure before the start of the dental appointment (opt-into the text message program and complete the baseline questionnaire)
- Failure to show up to scheduled dental appointment at the clinic
- Previous participation in the pilot phase
- Could not watch video during dental appointment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry M Goldman School of Dental Medicine
Boston, Massachusetts, 02118, United States
Related Publications (2)
Hart NJ, Goodman MS, Park H, Endrighi R, Jurasic MM, Cabral HJ, Borrelli B. Factors associated with dental fear and anxiety among smokers in urban dental clinics: a cross-sectional analysis. BMC Oral Health. 2026 Jan 13. doi: 10.1186/s12903-026-07682-3. Online ahead of print.
PMID: 41526906DERIVEDBorrelli B, Endrighi R, Jurasic MM, Hernandez H, Jones E, Ospina J, Cabral HJ, Quintiliani LM, Werntz S. A smoking cessation induction intervention via virtual reality headset during a dental cleaning: protocol for a randomized controlled trial. BMC Public Health. 2022 May 31;22(1):1074. doi: 10.1186/s12889-022-13427-y.
PMID: 35641925DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Belinda Borrelli, PhD
Henry M Goldman School of Dental Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Research assistants who are collecting outcome data will be masked.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 24, 2020
Study Start
January 4, 2021
Primary Completion
March 19, 2025
Study Completion
September 1, 2025
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
To enable verification of outcome measures, participant's data will be shared with the smoker quitline service and with the industry partner managing the text message programs.