Smoking ( Cigarette)NCT07505147
Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic
A study testing Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinic and Usual pre-anaesthetic care without structured smoking cessation in people with Smoking ( Cigarette), run by Pok Oi Hospital at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to evaluate whether a brief, nurse-delivered smoking cessation intervention can increase pre-operative smoking abstinence and improve perioperative outcomes among adult elective surgical patients who are current smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking ( Cigarette)
- What is being tested?
- Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinic and Usual pre-anaesthetic care without structured smoking cessation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years)
- Current smokers attending the pre-anaesthetic assessment clinic
- Scheduled for elective surgery within 6 months
Who cannot join
- Emergency surgery
- Patients having surgery day less than 7 days
- Cognitive impairment preventing consent
- Patients already receiving active treatment from other smoking cessation services
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Randomized Controlled Trial: Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic (PAAC)
The goal of this clinical trial is to evaluate whether a brief, nurse-delivered smoking cessation intervention can increase pre-operative smoking abstinence and improve perioperative outcomes among adult elective surgical patients who are current smokers. The main questions it aims to answer are:
Does a perioperative nurse-delivered AWARD brief counselling intervention with active referral and a tailored perioperative smoking cessation booklet increase the 7-day point prevalence abstinence rate on the day of surgery, biochemically validated by exhaled carbon monoxide and salivary cotinine?
Read more
Is this intervention feasible and acceptable in the pre-anaesthetic assessment clinic in terms of recruitment, retention, intervention fidelity, and patient compliance?
Researchers will compare patients receiving the nurse-led AWARD brief counselling plus active referral and tailored perioperative booklet to patients receiving usual pre-anaesthetic care without structured smoking cessation counselling, to see if the intervention leads to higher pre-operative abstinence and signals of reduced post-operative complications.
Participants will:
Attend the pre-anaesthetic assessment clinic where eligibility and baseline data (e.g., smoking behavior, readiness to quit, sociodemographic information) are collected and exhaled carbon monoxide is measured.
Be randomly assigned to either receive brief AWARD-model counselling with active referral and a tailored perioperative smoking cessation booklet from a trained perioperative nurse, or to continue with usual pre-anaesthetic care.
Have their smoking status reassessed on the day of surgery (including repeat CO and salivary cotinine testing) and at 1-month follow-up, along with collection of post-operative complication data and patient satisfaction with the smoking cessation support.
Read the detailed description
This is a pilot, two-arm, parallel-group, assessor-blinded randomized controlled trial conducted in the nurse-led Pre-anaesthetic Assessment Clinics of Pok Oi Hospital, targeting adult elective surgical patients who are current smokers and attend for pre-operative evaluation. The trial is designed primarily to assess feasibility, acceptability, and preliminary effectiveness of a brief, perioperative nurse-delivered smoking cessation intervention using the AWARD model (Ask, Warn, Advise, Refer, Do-it-again) integrated into routine pre-anaesthetic assessment workflow. It will generate key operational parameters (e.g., recruitment and retention rates, intervention fidelity, data completeness, contamination risk) and effect size estimates needed to design and power a future definitive trial.
After screening at the pre-anaesthetic assessment clinic, eligible smokers (carbon monoxide ≥4 ppm in exhaled breath and self-reported smoking in the past 7 days) who provide informed consent will complete a baseline self-administered questionnaire capturing smoking history (e.g., daily cigarette consumption, years of smoking, previous quit attempts), readiness to quit, perceived importance and confidence, psychosocial variables (social support, depression/anxiety, alcohol use), and sociodemographic data. They will then be randomized 1:1 using a computer-generated sequence with allocation concealment maintained by serially numbered, opaque, sealed envelopes opened only after consent. Due to the nature of the intervention, participants and counsellor nurses cannot be blinded, but outcome assessors, data collectors on the day of surgery, and statistical analysts will remain masked to group allocation until primary analyses are completed.
Participants allocated to the intervention arm will attend the Nurse Pre-Anaesthetic Assessment Clinic, where trained perioperative nurses deliver a single, structured 3-5-minute AWARD-based counselling session focused on the perioperative risks of continued smoking and the benefits of short-term cessation before surgery. The counselling is supported by objective feedback from exhaled carbon monoxide measurement, a tailored perioperative smoking cessation booklet specifically developed and content-validated with anaesthetist input, and an active referral process to the hospital's smoking cessation service (i.e., direct arrangement or linkage rather than passive provision of contact details). The "Do-it-again" component includes reinforcement of cessation messages on the day of surgery and a planned follow-up contact approximately one month after surgery to assess sustained abstinence and provide additional brief support as required. Intervention fidelity is promoted through a structured training program for perioperative nurses (covering the AWARD protocol, perioperative smoking risk education, motivational interviewing techniques, and use of CO monitoring), competency assessment before enrolment starts, and ongoing supervision and case-review meetings during the trial.
Control arm participants will receive usual pre-anaesthetic care, consisting of consultation with surgeons and anaesthetists without exposure to the nurse-led smoking cessation clinic. In this pathway, smoking advice, if offered, is unstructured and not guided by a standardized protocol; patients typically receive only the generic hospital smoking cessation leaflet and referral occurs at the discretion of individual clinicians without a formal active referral mechanism. This design allows the trial to compare the added value of a structured, nurse-delivered behavioural intervention plus active referral against the current standard of care in the same institutional setting.
The primary efficacy endpoint is 7-day point prevalence smoking abstinence on the day of surgery, verified biochemically by exhaled carbon monoxide (with a pre-specified cut-off indicating abstinence) and a salivary cotinine rapid test. Secondary endpoints include reductions in daily cigarette consumption between baseline and day of surgery, 1-month post-operative abstinence status, patient-reported satisfaction with the smoking cessation support received, and early post-operative complication rates within 30 days classified using a standardized surgical complication grading system. An independent operating theatre nurse, blinded to group allocation, will collect perioperative outcome data and biochemical validation measures on the day of surgery; post-operative complications will be extracted from electronic medical records by blinded researchers; and 1-month smoking status and satisfaction will be obtained via telephone follow-up.
Quantitative analyses for this pilot will be primarily descriptive, focusing on estimation rather than hypothesis testing. Feasibility outcomes (recruitment rate, retention, adherence to the AWARD protocol, completeness of outcome data) will be summarized with proportions and confidence intervals. Between-group comparisons of abstinence and complication rates will use appropriate categorical tests and regression models to provide preliminary effect size estimates and adjusted risk or odds ratios controlling for important covariates such as age, sex, baseline smoking intensity, and comorbidities. Continuous secondary outcomes (e.g., change in cigarettes per day) will be analyzed using parametric or non-parametric methods depending on distributional assumptions. These results will inform refinement of eligibility criteria, intervention delivery logistics, and sample size calculations for a subsequent adequately powered multicentre trial.
Overall, this detailed design embeds a standardized, scalable, nurse-led smoking cessation strategy directly into pre-operative assessment, tests its operational practicality in a real-world perioperative pathway, and explores its potential to improve short-term abstinence and surgical risk profiles in a high-risk smoker population.
- Conditions
- Smoking ( Cigarette)
- Being tested
- Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinic, Usual pre-anaesthetic care without structured smoking cessation
- Keywords
- Perioperative smoking cessation, Elective surgical patients who smoke, Nurse-led brief intervention, AWARD smoking cessation model, Pre-anaesthetic assessment clinic, Randomized controlled pilot trial, Carbon monoxide breath testing, Salivary cotinine validation, Postoperative pulmonary and wound complications, Perioperative nurse smoke cessation counselling
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinicProcedure or surgery
This intervention is a structured, nurse-led, behavioral smoking cessation program embedded within a nurse-run Pre-Anaesthetic Assessment Clinic for elective surgical patients who smoke. It consists of a single brief counselling session (approximately 3-5 minutes) delivered by trained perioperative nurses using the standardized AWARD model (Ask, Warn, Advise, Refer, Do-it-again), with content specifically tailored to perioperative risks and benefits of quitting before surgery. During the session, nurses use exhaled carbon monoxide testing as a motivational tool, provide a perioperative-focused, tailor-made smoking cessation booklet validated by a consultant anaesthetist, and make an active referral to the hospital's smoking cessation service rather than passive signposting. Fidelity is supported through dedicated nurse training, competency assessment, and ongoing supervision, and the intervention is reinforced on the day of surgery and at 1-month follow-up.
Usual pre-anaesthetic care without structured smoking cessationProcedure or surgery
Participants receive usual pre-anaesthetic care from surgeons and anaesthetists. Smoking advice, if given, is brief and unstructured, with no standardized counselling protocol, no tailored perioperative booklet, and no protocolised active referral beyond the routine hospital leaflet.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led AWARD brief smoking cessation counselling plus active referral and tailored perioperative | Experimental | Participants attend the Nurse Pre-Anaesthetic Assessment Clinic and receive brief nurse-delivered smoking cessation counselling using the AWARD model, plus active referral to hospital smoking cessation services and a tailored perioperative smoking cessation booklet, in addition to standard pre-anaesthetic assessment Receives: Procedure: Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinic |
| Usual pre-anaesthetic care without structured smoking cessation counselling | Active comparator | Participants receive usual pre-anaesthetic care from surgeons and anaesthetists without visiting the nurse-led clinic; smoking advice, if given, is unstructured and there is no standardized counselling, tailored booklet, or protocolized active referral beyond the general hospital leaflet Receives: Procedure: Usual pre-anaesthetic care without structured smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete smoking abstinence
A short-term Smoking Abstinence: The proportion of patients who report complete smoking abstinence (7-day point prevalence abstinence) biochemically validated by exhaled CO levels < 6 ppm on the day of surgery and negative result of Cotinine rapid salvia test and at 4 weeks post-counseling (1-Month Sustained Cessation Rate by self- report phone survey).
Measured: on the day of surgery and at 4 weeks post-surgery
Secondary outcomes (1)
The average number of cigarettes smoked per day at surgery day and 4 weeks post -surgery
The average number of cigarettes smoked per day at surgery day and 4 weeks post -surgery among those who have not achieved complete abstinence. Self-reported daily cigarette consumption (percentage reduction compared to baseline).
Measured: on the surgery day and 4 weeks post -surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Smoking ( Cigarette)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pok Oi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chim Tsz Ling, Pok Oi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505147
- Sponsor's protocol ID
- PokOiH
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ying X, Freedland KE, Powell LH, Stuart EA, Ehrhardt S, Mayo-Wilson E. Determining sample size for pilot trials: a tutorial. BMJ. 2025 Aug 8;390:e083405. doi: 10.1136/bmj-2024-083405. No abstract available.
PubMed 40780848Wetterslev J, Hansen EG, Kamp-Jensen M, Roikjaer O, Kanstrup IL. PaO2 during anaesthesia and years of smoking predict late postoperative hypoxaemia and complications after upper abdominal surgery in patients without preoperative cardiopulmonary dysfunction. Acta Anaesthesiol Scand. 2000 Jan;44(1):9-16. doi: 10.1034/j.1399-6576.2000.440103.x.
PubMed 10669265Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Warner, D. O., et al. (2020). "The effects of smoking cessation on surgical outcomes: A review of current evidence." Mayo Clinic Proceedings, 95(2), 393-402.
Siddiqui, M., et al. (2021). "Short-term smoking cessation interventions and their impact on surgical complications: A meta-analysis." Journal of Perioperative Nursing, 34(3), 221-229.
Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001188. doi: 10.1002/14651858.CD001188.
PubMed 10796619Ng CS, Yu CWS, Leung L, Wong EK, Ho SY, Ip DKM, Wu Y, Wang MP, Quan J. Economic costs of tobacco-related diseases in Hong Kong in 2021. Tob Control. 2026 Apr 13;35(2):179-186. doi: 10.1136/tc-2024-058817.
PubMed 39613330Moore, R. A., et al. (2020). "Smoking cessation before surgery and its impact on postoperative outcomes: A systematic review." Cochrane Database of Systematic Reviews, (8), CD012852.
Andrews K, Bale P, Chu J, Cramer A, Aveyard P. A randomized controlled trial to assess the effectiveness of a letter from a consultant surgeon in causing smokers to stop smoking pre-operatively. Public Health. 2006 Apr;120(4):356-8. doi: 10.1016/j.puhe.2005.10.013. Epub 2006 Feb 13. No abstract available.
PubMed 16473379Centers for Disease Control and Prevention (CDC). (2022). "The impact of smoking on surgical outcomes." Retrieved from CDC website.
Bissett, K., Ascenzi. J., & Whalen, M. (2025). Johns Hopkins evidence-based practice for nurses and healthcare professionals: Model and guidelines. 5th ed. Sigma Theta Tau International
American Nurses Association (ANA). (2021). "Nurses' role in tobacco cessation and surgical outcomes." Retrieved from ANA website.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial: Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic (PAAC)
- ClinicalTrials.gov ID
- NCT07505147
- Acronym / sponsor ID
- PokOiH
- Conditions
- Smoking ( Cigarette)
- Keywords
- Perioperative smoking cessation, Elective surgical patients who smoke, Nurse-led brief intervention, AWARD smoking cessation model, Pre-anaesthetic assessment clinic, Randomized controlled pilot trial, Carbon monoxide breath testing, Salivary cotinine validation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Pok Oi HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether a brief, nurse-delivered smoking cessation intervention can increase pre-operative smoking abstinence and improve perioperative outcomes among adult elective surgical patients who are current smokers. The main questions it aims to answer are:
Does a perioperative nurse-delivered AWARD brief counselling intervention with active referral and a tailored perioperative smoking cessation booklet increase the 7-day point prevalence abstinence rate on the day of surgery, biochemically validated by exhaled carbon monoxide and salivary cotinine?
Is this intervention feasible and acceptable in the pre-anaesthetic assessment clinic in terms of recruitment, retention, intervention fidelity, and patient compliance?
Researchers will compare patients receiving the nurse-led AWARD brief counselling plus active referral and tailored perioperative booklet to patients receiving usual pre-anaesthetic care without structured smoking cessation counselling, to see if the intervention leads to higher pre-operative abstinence and signals of reduced post-operative complications.
Participants will:
Attend the pre-anaesthetic assessment clinic where eligibility and baseline data (e.g., smoking behavior, readiness to quit, sociodemographic information) are collected and exhaled carbon monoxide is measured.
Be randomly assigned to either receive brief AWARD-model counselling with active referral and a tailored perioperative smoking cessation booklet from a trained perioperative nurse, or to continue with usual pre-anaesthetic care.
Have their smoking status reassessed on the day of surgery (including repeat CO and salivary cotinine testing) and at 1-month follow-up, along with collection of post-operative complication data and patient satisfaction with the smoking cessation support.
Detailed description
This is a pilot, two-arm, parallel-group, assessor-blinded randomized controlled trial conducted in the nurse-led Pre-anaesthetic Assessment Clinics of Pok Oi Hospital, targeting adult elective surgical patients who are current smokers and attend for pre-operative evaluation. The trial is designed primarily to assess feasibility, acceptability, and preliminary effectiveness of a brief, perioperative nurse-delivered smoking cessation intervention using the AWARD model (Ask, Warn, Advise, Refer, Do-it-again) integrated into routine pre-anaesthetic assessment workflow. It will generate key operational parameters (e.g., recruitment and retention rates, intervention fidelity, data completeness, contamination risk) and effect size estimates needed to design and power a future definitive trial.
After screening at the pre-anaesthetic assessment clinic, eligible smokers (carbon monoxide ≥4 ppm in exhaled breath and self-reported smoking in the past 7 days) who provide informed consent will complete a baseline self-administered questionnaire capturing smoking history (e.g., daily cigarette consumption, years of smoking, previous quit attempts), readiness to quit, perceived importance and confidence, psychosocial variables (social support, depression/anxiety, alcohol use), and sociodemographic data. They will then be randomized 1:1 using a computer-generated sequence with allocation concealment maintained by serially numbered, opaque, sealed envelopes opened only after consent. Due to the nature of the intervention, participants and counsellor nurses cannot be blinded, but outcome assessors, data collectors on the day of surgery, and statistical analysts will remain masked to group allocation until primary analyses are completed.
Participants allocated to the intervention arm will attend the Nurse Pre-Anaesthetic Assessment Clinic, where trained perioperative nurses deliver a single, structured 3-5-minute AWARD-based counselling session focused on the perioperative risks of continued smoking and the benefits of short-term cessation before surgery. The counselling is supported by objective feedback from exhaled carbon monoxide measurement, a tailored perioperative smoking cessation booklet specifically developed and content-validated with anaesthetist input, and an active referral process to the hospital's smoking cessation service (i.e., direct arrangement or linkage rather than passive provision of contact details). The "Do-it-again" component includes reinforcement of cessation messages on the day of surgery and a planned follow-up contact approximately one month after surgery to assess sustained abstinence and provide additional brief support as required. Intervention fidelity is promoted through a structured training program for perioperative nurses (covering the AWARD protocol, perioperative smoking risk education, motivational interviewing techniques, and use of CO monitoring), competency assessment before enrolment starts, and ongoing supervision and case-review meetings during the trial.
Control arm participants will receive usual pre-anaesthetic care, consisting of consultation with surgeons and anaesthetists without exposure to the nurse-led smoking cessation clinic. In this pathway, smoking advice, if offered, is unstructured and not guided by a standardized protocol; patients typically receive only the generic hospital smoking cessation leaflet and referral occurs at the discretion of individual clinicians without a formal active referral mechanism. This design allows the trial to compare the added value of a structured, nurse-delivered behavioural intervention plus active referral against the current standard of care in the same institutional setting.
The primary efficacy endpoint is 7-day point prevalence smoking abstinence on the day of surgery, verified biochemically by exhaled carbon monoxide (with a pre-specified cut-off indicating abstinence) and a salivary cotinine rapid test. Secondary endpoints include reductions in daily cigarette consumption between baseline and day of surgery, 1-month post-operative abstinence status, patient-reported satisfaction with the smoking cessation support received, and early post-operative complication rates within 30 days classified using a standardized surgical complication grading system. An independent operating theatre nurse, blinded to group allocation, will collect perioperative outcome data and biochemical validation measures on the day of surgery; post-operative complications will be extracted from electronic medical records by blinded researchers; and 1-month smoking status and satisfaction will be obtained via telephone follow-up.
Quantitative analyses for this pilot will be primarily descriptive, focusing on estimation rather than hypothesis testing. Feasibility outcomes (recruitment rate, retention, adherence to the AWARD protocol, completeness of outcome data) will be summarized with proportions and confidence intervals. Between-group comparisons of abstinence and complication rates will use appropriate categorical tests and regression models to provide preliminary effect size estimates and adjusted risk or odds ratios controlling for important covariates such as age, sex, baseline smoking intensity, and comorbidities. Continuous secondary outcomes (e.g., change in cigarettes per day) will be analyzed using parametric or non-parametric methods depending on distributional assumptions. These results will inform refinement of eligibility criteria, intervention delivery logistics, and sample size calculations for a subsequent adequately powered multicentre trial.
Overall, this detailed design embeds a standardized, scalable, nurse-led smoking cessation strategy directly into pre-operative assessment, tests its operational practicality in a real-world perioperative pathway, and explores its potential to improve short-term abstinence and surgical risk profiles in a high-risk smoker population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led AWARD brief smoking cessation counselling plus active referral and tailored perioperative | Experimental | Procedure: Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinicParticipants attend the Nurse Pre-Anaesthetic Assessment Clinic and receive brief nurse-delivered smoking cessation counselling using the AWARD model, plus active referral to hospital smoking cessation services and a tailored perioperative smoking cessation booklet, in addition to standard pre-anaesthetic assessment |
| Usual pre-anaesthetic care without structured smoking cessation counselling | Active comparator | Procedure: Usual pre-anaesthetic care without structured smoking cessationParticipants receive usual pre-anaesthetic care from surgeons and anaesthetists without visiting the nurse-led clinic; smoking advice, if given, is unstructured and there is no standardized counselling, tailored booklet, or protocolized active referral beyond the general hospital leaflet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years)
- Current smokers attending the pre-anaesthetic assessment clinic
- Scheduled for elective surgery within 6 months
Key exclusion criteria (4 listed)
- Emergency surgery
- Patients having surgery day less than 7 days
- Cognitive impairment preventing consent
- Patients already receiving active treatment from other smoking cessation services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinicThis intervention is a structured, nurse-led, behavioral smoking cessation program embedded within a nurse-run Pre-Anaesthetic Assessment Clinic for elective surgical patients who smoke. It consists of a single brief counselling session (approximately 3-5 minutes) delivered by trained perioperative nurses using the standardized AWARD model (Ask, Warn, Advise, Refer, Do-it-again), with content specifically tailored to perioperative risks and benefits of quitting before surgery. During the session, nurses use exhaled carbon monoxide testing as a motivational tool, provide a perioperative-focused, tailor-made smoking cessation booklet validated by a consultant anaesthetist, and make an active referral to the hospital's smoking cessation service rather than passive signposting. Fidelity is supported through dedicated nurse training, competency assessment, and ongoing supervision, and the intervention is reinforced on the day of surgery and at 1-month follow-up. | Procedure or surgery | Nurse-led AWARD brief smoking cessation counselling plus active referral and tailored perioperative |
| Usual pre-anaesthetic care without structured smoking cessationParticipants receive usual pre-anaesthetic care from surgeons and anaesthetists. Smoking advice, if given, is brief and unstructured, with no standardized counselling protocol, no tailored perioperative booklet, and no protocolised active referral beyond the routine hospital leaflet. | Procedure or surgery | Usual pre-anaesthetic care without structured smoking cessation counselling |
Primary outcome
Complete smoking abstinence
Time frame: on the day of surgery and at 4 weeks post-surgery
A short-term Smoking Abstinence: The proportion of patients who report complete smoking abstinence (7-day point prevalence abstinence) biochemically validated by exhaled CO levels < 6 ppm on the day of surgery and negative result of Cotinine rapid salvia test and at 4 weeks post-counseling (1-Month Sustained Cessation Rate by self- report phone survey).
1 secondary outcome
The average number of cigarettes smoked per day at surgery day and 4 weeks post -surgery
Time frame: on the surgery day and 4 weeks post -surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 40780848Ying X, Freedland KE, Powell LH, Stuart EA, Ehrhardt S, Mayo-Wilson E. Determining sample size for pilot trials: a tutorial. BMJ. 2025 Aug 8;390:e083405. doi: 10.1136/bmj-2024-083405. No abstract available.
- Background: PubMed 10669265Wetterslev J, Hansen EG, Kamp-Jensen M, Roikjaer O, Kanstrup IL. PaO2 during anaesthesia and years of smoking predict late postoperative hypoxaemia and complications after upper abdominal surgery in patients without preoperative cardiopulmonary dysfunction. Acta Anaesthesiol Scand. 2000 Jan;44(1):9-16. doi: 10.1034/j.1399-6576.2000.440103.x.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- BackgroundWarner, D. O., et al. (2020). "The effects of smoking cessation on surgical outcomes: A review of current evidence." Mayo Clinic Proceedings, 95(2), 393-402.
- BackgroundSiddiqui, M., et al. (2021). "Short-term smoking cessation interventions and their impact on surgical complications: A meta-analysis." Journal of Perioperative Nursing, 34(3), 221-229.
- Background: PubMed 10796619Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001188. doi: 10.1002/14651858.CD001188.
- Background: PubMed 39613330Ng CS, Yu CWS, Leung L, Wong EK, Ho SY, Ip DKM, Wu Y, Wang MP, Quan J. Economic costs of tobacco-related diseases in Hong Kong in 2021. Tob Control. 2026 Apr 13;35(2):179-186. doi: 10.1136/tc-2024-058817.
- BackgroundMoore, R. A., et al. (2020). "Smoking cessation before surgery and its impact on postoperative outcomes: A systematic review." Cochrane Database of Systematic Reviews, (8), CD012852.
- Background: PubMed 16473379Andrews K, Bale P, Chu J, Cramer A, Aveyard P. A randomized controlled trial to assess the effectiveness of a letter from a consultant surgeon in causing smokers to stop smoking pre-operatively. Public Health. 2006 Apr;120(4):356-8. doi: 10.1016/j.puhe.2005.10.013. Epub 2006 Feb 13. No abstract available.
- BackgroundCenters for Disease Control and Prevention (CDC). (2022). "The impact of smoking on surgical outcomes." Retrieved from CDC website.
- BackgroundBissett, K., Ascenzi. J., & Whalen, M. (2025). Johns Hopkins evidence-based practice for nurses and healthcare professionals: Model and guidelines. 5th ed. Sigma Theta Tau International
- BackgroundAmerican Nurses Association (ANA). (2021). "Nurses' role in tobacco cessation and surgical outcomes." Retrieved from ANA website.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinic and Usual pre-anaesthetic care without structured smoking cessation in people with Smoking ( Cigarette), run by Pok Oi Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tsz Ling Chim (852 57978026, ctl374@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete smoking abstinence (time frame: on the day of surgery and at 4 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07505147, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.