Smoking, Cessation Clinical Trial
Official title:
Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Usability Study
| Verified date | May 2021 |
| Source | Boston University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | May 31, 2020 |
| Est. primary completion date | May 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Goldman School of Dental Medicine | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Boston University | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility of the Smoking Cessation Education Program | The number of participants who watched the video and used the text messaging for a month. | 6 weeks | |
| Primary | Participant Acceptability Rate of the Program | Participants were asked to rate the acceptability of the program by answering an investigator developed acceptability question with a scale of 1 to 7, where 1= the program was not acceptable and 7= the program was very acceptable. Scores could range from 1 to 7, and higher scores are associated with greater acceptability of the program. | 6 weeks | |
| Primary | Participant Satisfaction With the Program | Participants were asked to rate their satisfaction of the program by answering an investigator developed satisfaction question with a scale of 1 to 5, where 1= they were not satisfied with the program and 5= they were very satisfied with the program. Higher scores were associated with greater satisfaction with the program. | 6 weeks | |
| Secondary | Attitudes About Smoking | The number of subjects who 'agreed' or 'strongly agreed' that the educational video improved their attitude towards quitting smoking. | 6 weeks | |
| Secondary | Change in Number of Cigarettes Smoked Per Day | An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily | Baseline, 6 weeks | |
| Secondary | The Number of Participants With Quit Attempts Lasting = 24 Hours | The number of participants who attempted to quit smoking for 24 hours or more at follow-up because they wanted to quit (not due to hospitalization or illness) based on an investigator-developed survey that asked participants questions about the number of quit attempts lasting = 24 hours | 6 weeks | |
| Secondary | Methods for Quitting Smoking | An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking | 6 weeks |