Clinical trial NCT04247061: Usability Study of a Smoking Cessation Intervention During a Dental Cleaning
Official title: Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Usability Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking, Cessation
Keywords: Dental cleaning
Video
Text messages
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-01-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this usability study is to pilot test the recruitment procedures, data acquisition methods, and text message program integration required to support the planning of a future clinical trial. Approximately 15 smokers who are patients of the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center and have an upcoming dental prophylaxis or scaling and root planing (henceforth referred to as 'teeth cleaning') appointment will be recruited. During the dental cleaning, participants will watch a brief educational video that provides guidance and advice on smoking cessation.

At the end of the dental appointment, participants will complete a survey about their experience watching the video and their attitudes towards smoking cessation. Participants will also receive other smoking cessation resources with instructions on how to access the services. Participants will then use the one-month text message program developed by the investigators to motivate and facilitate contact with the smoking cessation resources.

At the end of the one-month text message program, participants will complete a survey about their experience during the text message program, their smoking habits, and attitudes towards smoking cessation. The duration of the study will be approximately six-weeks.


Eligibility criteria: Inclusion Criteria:

* Must be a patient of the Boston University, Henry M Goldman School of Dental Medicine patient treatment center
* Must have smoked 100 cigarettes or more (not e-cigarettes or vaping) in lifetime
* Must have smoked cigarettes (not e-cigarettes or vaping) 'most days' or 'every day' in the past week
* Must read and write fluently in English
* Must be willing to watch a video during the dental hygiene appointment
* Must have the visual capacity to watch a video
* Ability to wear in-ear headphones
* Must have a mobile phone capable of receiving and sending text messages (SMS)
* live in Greater Boston area for the next two months
* Have a cell phone carrier that can receive text message from our system

Exclusion Criteria:

-Planning to move out of the Greater Boston area within the next two months

Primary outcomes:
measure: Feasibility of the Smoking Cessation Education Program
timeFrame: 6 weeks
measure: Participant Acceptability Rate of the Program
timeFrame: 6 weeks
measure: Participant Satisfaction With the Program
timeFrame: 6 weeks
Secondary outcomes:
measure: Attitudes About Smoking
timeFrame: 6 weeks
measure: Change in Number of Cigarettes Smoked Per Day
timeFrame: Baseline, 6 weeks
measure: The Number of Participants With Quit Attempts Lasting ≥ 24 Hours
timeFrame: 6 weeks
measure: Methods for Quitting Smoking
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Goldman School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Henry M Goldman School of Dental Medicine
name: Belinda Borrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: