Usability Study of a Smoking Cessation Intervention During a Dental Cleaning
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|ClinicalTrials.gov Identifier: NCT04247061|
Recruitment Status : Suspended (Currently suspended due to COVID-19 policies.)
First Posted : January 29, 2020
Last Update Posted : April 21, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking, Cessation||Other: Educational video Other: Text-message program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Usability Study|
|Actual Study Start Date :||February 4, 2020|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Smoking Cessation intervention
At a dental cleaning visit, participants will watch a brief educational video that provides guidance and advice on smoking cessation. Participants will then interact with a text program for a month to motivate them to use smoking cessation resources. Participants will also be required to make contact with the resources in order to demonstrate feasibility of study flow.
Other: Educational video
One of two different 10 minute educational videos on smoking cessation will be viewed by participants during a dental cleaning visit. The video that is watched will depend on participants' level of motivation to quit and project needs
Other: Text-message program
A one-month text message program to motivate and facilitate contact with smoking cessation resources.
- Feasibility of the smoking cessation education program [ Time Frame: 6 weeks ]The number of participants who watched the video and used the text messaging for a month will be divided by the total number of participants enrolled to determine the feasibility of the intervention.
- Participant acceptability rate of the program [ Time Frame: 6 weeks ]The number of participants who liked the video and the text messaging for a month will be divided by the total number of participants enrolled to calculate the acceptability rate.
- Participant satisfaction with the program [ Time Frame: 6 weeks ]An investigator-developed survey will ask participants questions about how satisfied they were with the smoking cessation program
- Change in attitudes about smoking [ Time Frame: Baseline, 6 weeks ]An investigator-developed survey will ask participants questions about their attitudes toward smoking
- Change in number of cigarettes smoked per day [ Time Frame: Baseline, 6 weeks ]An investigator-developed survey will ask participants questions about the number of cigarettes smoked daily
- Change in the number of quit attempts lasting ≥ 24 hours [ Time Frame: Baseline, 6 weeks ]An investigator-developed survey will ask participants questions about the number of quit attempts lasting ≥ 24 hours
- Methods for quitting smoking [ Time Frame: 6 weeks ]An investigator-developed survey will ask participants questions about what methods they used to try to quit smoking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247061
|United States, Massachusetts|
|Goldman School of Dental Medicine|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Belinda Borrelli, PhD||Henry M Goldman School of Dental Medicine|