Feasibility of providing support to stop the use of smokeless tobacco through dentists in Pakistan

Behavior change intervention for smokeless tobacco (ST) cessation delivered through dentists within a dental setting: a pilot feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18072109

Enrollment

100

Registered

2022-01-13

Start date

2022-01-25

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smokeless tobacco cessation in dental patients Other

Interventions

Step 1: BISCA- (Behavioral support Intervention for Smokeless Tobacco Cessation in South Asians) is a behavioral support intervention for smokeless tobacco(ST) cessation. This study aims to deliver BI

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and above. 2. Regular smokeless tobacco users (regular use = at least once in 7 days for 6 months or more). 3. Those residing in the catchment area of the study sites. 4. Willingness to visit the study site multiple times. 5. Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Currently accessing cessation support. 2. Less than 18 years old. 3. Those residing out of the catchment area of the study sites. 4. Unwilling or unable to provide written informed consent.

Design outcomes

Primary

Measure	Time frame
1. Eligibility rate: will be assessed from the screening record at the end of recruitment. 2. Patients willingness to participate in the trial: Will be assessed from the screening record at the end of the trial. 3. Dentists’ willingness to participate in the trial: Will be measured by counting the number of dentists consenting to participate versus the number of eligible dentists working in the selected wards at the study sites. 4. Recruitment rate: Will measured by counting the number of participants who have consented to participate in the study out of the total eligible participants. 5. Retention rate: Will be measured by counting the number of participants who remained in the study at end of 6 month follow up after the trial. 6. Randomized group contamination rates (i.e. the extent of cross-over between the two arms of the trial) will be established by audio recording the sessions delivered by the dentists (both of the arms) 7. Self-reported ST use (Use of ST and frequency of ST use per day), will be assessed for all patients. 8. Tobacco dependence scores( mean +/- SD) will be estimated using Fagerström test for nicotine dependence for smokeless tobacco(FTND-ST)& Oklahoma Scale for Smokeless Tobacco Dependence (OSSTD) 9. Participants adherence to the intervention will be measured by estimating the completion rates of the self-help calendars. 10. Fidelity to the intervention: Will be assessed by audio recording of the sessions. Fidelity index for the intervention already exists which consists of 29-items. Of these 22 items (representing the intervention components) are included in the ‘adherence index’ whereas seven items (assessing the competence with which the intervention is delivered)- are included in the ‘quality index’. 11. Self-reported quit rates will be measured at 3 and 6 month telephonic follow up after the trial. 12. Biochemical verification of quit rates will be done at 6 months following trial completion. 13. Acceptability of the dentists and issu	—

Measure

Time frame

1. Eligibility rate: will be assessed from the screening record at the end of recruitment. 2. Patients willingness to participate in the trial: Will be assessed from the screening record at the end of the trial. 3. Dentists’ willingness to participate in the trial: Will be measured by counting the number of dentists consenting to participate versus the number of eligible dentists working in the selected wards at the study sites. 4. Recruitment rate: Will measured by counting the number of participants who have consented to participate in the study out of the total eligible participants. 5. Retention rate: Will be measured by counting the number of participants who remained in the study at end of 6 month follow up after the trial. 6. Randomized group contamination rates (i.e. the extent of cross-over between the two arms of the trial) will be established by audio recording the sessions delivered by the dentists (both of the arms) 7. Self-reported ST use (Use of ST and frequency of ST use per day), will be assessed for all patients. 8. Tobacco dependence scores( mean +/- SD) will be estimated using Fagerström test for nicotine dependence for smokeless tobacco(FTND-ST)& Oklahoma Scale for Smokeless Tobacco Dependence (OSSTD) 9. Participants adherence to the intervention will be measured by estimating the completion rates of the self-help calendars. 10. Fidelity to the intervention: Will be assessed by audio recording of the sessions. Fidelity index for the intervention already exists which consists of 29-items. Of these 22 items (representing the intervention components) are included in the ‘adherence index’ whereas seven items (assessing the competence with which the intervention is delivered)- are included in the ‘quality index’. 11. Self-reported quit rates will be measured at 3 and 6 month telephonic follow up after the trial. 12. Biochemical verification of quit rates will be done at 6 months following trial completion. 13. Acceptability of the dentists and issu

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Pakistan

Contacts

Public ContactShaista Rasool

s.rasool-3@sms.ed.ac.uk+92 3329144869

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026