A Pilot Randomized Controlled Trial: Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic (PAAC)
Phase: NA
Conditions: Smoking ( Cigarette)
Sponsor: Pok Oi Hospital

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STUDY PROTOCOL 
 
1.Project Title: 
A Pilot Randomized Controlled Trial: Effectiveness of Brief Smoking Cessation 
Counselling in Pre-Anaesthesia Assessment Clinic (PAAC)  
 
Investigators Principal Investigator 
Ms. Chim Tsz Ling, Associate Nurse Consultant, Anaesthesia and Operating Theatre 
Services, Pok Oi Hospital  
 
Co-investigators 
-Ms. Yip Pui Ling, Nurse Consultant, Anaesthesia and Operating Theatre Services, New 
Territories West Cluster 
 
-Ms. Tong Yin Ling, Advanced Practice Nurse, Anaesthesia and Operating Theatre 
Services, Pok Oi Hospital 
 
-Dr. He, Wanjia Aaron, Research Assistant Professor, School of Public Health, The 
University of Hong Kong  
 
 
2.Study sites 
The study will be conducted in the Pre-Anaesthesia Assessment Clinic in Pok Oi Hospital 
(POH). 
 
3.Aims of the study 
The aim of the study is to  
 
a. evaluation the feasibility and preliminary effectiveness of a perioperative nurse-
delivered AWARD brief intervention in the Pre-anaesthetic assessment clinic, 
compared with usual care, on smoking abstinence on the day of surgery among adult 
smokers scheduled for elective surgery.  
 
b. establish the effectiveness of the nurse-delivered intervention in increasing pre-
operative smoking cessation rates and ensure the methodology is sound, the 
intervention is deliverable, and the necessary statistical parameters are obtained to 
justify and design a large-scale trial.  
 

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c. To determine effectiveness of nurse-delivered brief counselling using the AWARD 
model plus active referral on increasing pre-operative smoking cessation rates in  PAC  
POH.  
 
The hypothesis 
Is the brief counselling for the preoperative smoking patient can increase smoking 
cessation rate, defined as abstinence for at least 7 days prior to surgery. 
 
 
4.Outcome measure(s) 
 
Primary outcomes 
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). 
 
Secondary Outcomes 
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).  
 
 
The rate of major postoperative complications (e.g., pneumonia, wound infection, 
cardiovascular events) within 30 days post-surgery, as data will be extracted from 
electronic medical records (CDARS). 
 
Patient Satisfaction Mean score on a 5-point Likert scale assessing satisfaction with 
smoking cessation support received, administered via questionnaire at 1 month’s post-
surgery. Assesses satisfaction with the counselling service, leaflet content, and overall care. 
 
 
 
5.Literature Review 
Smoking and Increased Surgical Risks 
Smoking is a significant modifiable risk factor that negatively impacts surgical outcomes. 
It increases the likelihood of postoperative complications, including impaired wound 
healing, infections, cardiovascular events, and prolonged hospital stays. The physiological 
effects of smoking—such as reduced oxygen delivery, impaired immune response, and 

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vasoconstriction—directly contribute to these risks (Warner et al., 2020). Evidence shows 
that smokers have a 30–50% higher risk of surgical site infections and other complications 
compared to non-smokers (CDC, 2022). 
 
Benefits of Preoperative Smoking Cessation 
 Preoperative smoking cessation has been shown to significantly improve surgical 
outcomes. According to a Cochrane Review, stopping smoking for 4–8 weeks prior to 
surgery reduces the risk of complications by up to 41%, particularly for wound healing and 
pulmonary complications (Moore et al., 2020). Furthermore, even brief interventions, such 
as quitting 48 hours before surgery, can improve oxygenation and reduce carbon monoxide 
levels in the blood, leading to better postoperative outcomes (Siddiqui et al., 2021). 
 
The Role of Nurses in Smoking Cessation 
Nurses are uniquely positioned to provide smoking cessation counseling due to their 
frequent interactions with patients. A meta-analysis by Rice et al. (2020) demonstrated that 
nurse-led smoking cessation interventions—including brief advice, education, and referrals 
to cessation programs—improve quit rates and reduce smoking-related complications. The 
American Nurses Association (ANA) emphasizes that nurses play a critical role in 
preoperative education and should incorporate smoking cessation advice as part of their 
routine care (ANA, 2021). 
 
Active referral  
The importance of active referral is not only supported by recent clinical data but is also a 
core tenet of international tobacco control policy. The WHO Framework Convention on 
Tobacco Control (FCTC), specifically Article 14 (Demand reduction measures concerning 
tobacco dependence and cessation), provides the global blueprint for effective cessation 
services. The importance of active referral is not only supported by recent clinical data but 
is also a core tenet of international tobacco control policy. The WHO Framework 
Convention on Tobacco Control (FCTC), specifically Article 14 (Demand reduction 
measures concerning tobacco dependence and cessation), provides the global blueprint for 
effective cessation services. 
 
6.Methodology 
Study Design 
This is a two-arm parallel, assessor-blinded, pilot randomized controlled trial (RCT) design. 
The study will be conducted at the Nurse-led Pre-operative Anaesthetic Assessment Clinics 
(PAC) of Pok Oi Hospital (POH). The intervention included using of a brief counselling 
intervention (AWARD model) with active referral plus tailored made booklet to increase 
the smoke cessation rate on the day of surgery / referral rate in PAC.  The design adheres 
to the CONSORT (Consolidated Standards of Reporting Trals) statement. (Figure 1). 

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Perioperative nurses will be recruited and trained as counselors to provide brief cessation 
advice to the intervention group smoker in the PAC. 
 
 
 
 
Recruitment and Randomization 
Screening of eligible smoking patients will be done at the pre-operative assessment clinic. 
All smokers will be given a general smoke advice leaflet provided from smoke cessation 

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service and will provide active referral if they are willing for. They will be invited to join 
the study and to sign the written consent; to complete a self-administrated baseline 
questionnaire (e.g sex, age, number of tobaccos use daily, proposed operation….) and 
exhaling carbon monoxide >=4ppm. Then they will be randomly allocated to the 
intervention or control group with 1:1 ratio.  
For the randomization method, it will be done by using serially numbered, opaque and 
sealed envelopes (SNOSEs). The cards inside envelopes will involve either intervention or 
control. A project assistant will create a random sequence for group allocation using a 
random number generator, accompany by serially numbered identifiers for the envelopes. 
After obtaining informed consent, the assistant opens a sequential number envelope to 
maintain allocation concealment. Blinding of the participants and counsellors are 
impossible due to the nature of the intervention. Assessors and statistical analysts will be 
masked until the predefined analyses are completed. Data analysts will be blinded to group 
allocation. Due to the nature of the intervention, the nurses delivering the counselling 
cannot be blinded. Randomization: Computer-generated random sequence will be used, 
and allocation concealment will be maintained using sealed, opaque envelopes. 
 
Inclusion Criteria  
Adult elective surgical patients who are current smokers, aged 18 years or above, scheduled 
for elective surgery, attending the Pre-Anaesthetic Assessment Clinic (PAAC), who have 
smoked with the past 7 days with exhaled carbon monoxide >=4ppm and can understand 
and speak Cantonese. 
 
Exclusion Criteria  
Includes patients undergoing emergency surgery; patients having surgery day less than 7 
days; willing to be referred the smoke cessation service on admission of PAC after 
receiving the standard leaflet of smoking cessation from hospital smoking cessation service; 
patient with cognitive impairment or inability to comply with counselling and follow-up or 
patients already receiving active treatment from other smoking cessation services or 
patients diagnosed with a mental disease or on regular psychotropic drugs. 
 
 
Intervention and Control Group 
The intervention group participants will be assigned to attend Nurse Pre-Anaesthetic 
Assessment Clinic (NPAC). They will receive smoke intervention (AWARD model 
counselling) and active referral plus tailored made booklet regarding hazard related to 
increasing anaesthteic and surgery risk by the perioperative nurse.  
 

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The control group participants will be provided with usual care (visiting surgeons and 
anaesthetists without visiting NPAC). Unstandardized smoke advice maybe provided 
during the Pre-anaesthetic assessment service visit.   
 
The sample size  
For this pilot RCT on the effectiveness of brief smoke counseling in the perioperative 
anesthetic clinic is determined pragmatically to obtain stable estimates of key parameters 
(e.g., variance, recruitment rate) necessary for designing a definitive main trial (Whitehead, 
Julious, Cooper and Campbell, 2016). This approach is crucial for minimizing the overall 
sample size of the subsequent full-scale trial (Ying, Freedland, Powell, Stuart, Ehrhardt & 
Mayo-Wilson, 2025).  We have chosen a sample size of 50 participants per group, which 
is generally considered sufficient to provide robust estimates of the parameters required for 
the main trial's power calculation. For our two-arm design (intervention vs. control), this 
requires a total of 100 completed participants. To account for a projected 20% attrition rate, 
the total recruitment target is adjusted to 125 participants (100 / 0.80 ≈ 125) over 4-6 
months.  
 
Counsellor nurses Training and Supervision 
 
Prior to start participant enrollment, all designated research perioperative nurse will 
participate in a mandatory training. This training is structured around three core modules 
essential for the study's success within the Perioperative Anaesthetic Clinic (PAC) setting. 
The modules will focus on: (1) comprehensive instruction on the AWARD model 
counselling protocol, including its application in brief sessions, the specific support 
mechanisms utilized, and effective recruitment techniques tailored for the PAAC 
environment, such as the use of exhaled carbon monoxide (CO) test; (2) in-depth education 
regarding the physiological risks associated with smoking and the clinical advantages of 
cessation (the content involved in the counselling will be guide by the tailor made 
perioperative booklet). The booklet was designed by the perioperative team nurses and the 
content is verified by consultant anaesthetist.  and (3) mastery of general smoking cessation 
methodologies and AWARDS model interviewing skills. 
To ensure fidelity to the intervention, the counsellor nurses’ competency will be assessed 
using a pre- and post-training evaluation tool designed to measure their knowledge, 
attitudes, and practical application skills concerning smoking cessation.  
 
Ongoing supervision and support will be provided by experienced research personnel 
throughout the recruitment phase. Furthermore, to assess recruitment feasibility, detailed 
records will be kept on all eligible smokers approached in the PAC. Interventionists will 
meticulously document the total number of individuals approached and record the reasons 

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provided by those who decline participation if available. A weekly group case review will 
be implemented to discuss active cases and address any emerging challenges. 
 
CO exhaled reading result will be done and will be used for part of counselling. Active 
referral and booklet will be provided and facilitate the counselling.   The participants will 
be informed that they may withdraw from the study at any time without giving a reason. 
Participants who self-report abstinence for more than 7 days will be invited for biochemical 
validation and Cotinine test). Reinforcement about the benefit of quit smoking will also be 
done on the surgery day.  
 
7. Procedure 
Baseline Assessment  
In order to determine the baseline differences in current usual care and prepare the 
necessary resources for implementing the intervention. The participants will be assessed at 
baseline in PAC. The baseline questionnaire will measure the participants’ smoking 
behavior (eg, daily cigarette takes, age to start smoking, and quit attempts), readiness to 
quit, reasons for quitting, social support, perceived self-efficacy of quitting (importance, 
difficulties and confidence), depression and anxiety, alcohol consumption, and 
sociodemographic characteristics. 
 
Data Collection 
An independent operating theatre nurse (blinded to group allocation) will collect the 
primary outcome data on the day of surgery, including self-reported at least 7-day PPA and 
CO test results and negative result of the salivary cotinine test. 
On the day of surgery, self-reported 7-day smoking abstinence status and repeat exhaled 
CO  testing and Cotinine salivary test by OT nurses. Recording of any intraoperative or 
early postoperative complications from medical records. 
 
In order to collect secondary outcome data and perform statistical analysis, follow-up via 
telephone to collect self-reported smoking status, smoking reduction, and patient 
satisfaction survey data.  The post-operative complication rate will also be assessed in 
electronic medical record data at discharge or within 30 days post-operatively. Blinded 
researchers will assess post-operative complications using the Clavien-Dindo classification 
system. 
 
Postoperative phone follow up 1 month after surgery for sustained smoking status (Self-
reported 7-day point-prevalence tobacco abstinence); patients satisfaction and self-efficacy 
questionnaires regarding smoking cessation support. The data collected will follow to data 
protection standards. 
 

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Intervention Group  
Control Group  
Leaflet 
from 
hospital 
smoke 
cessation service  
     
 
Brief counselling (AWARD) + active 
refer + tailor made booklet for 
preoperative smoking cessation  
  
 
 
 
8. Data Analysis 
 
Descriptive Statistics for Staff Survey before intervention start 
Calculate frequencies and percentages for categorical variables such as awareness levels, 
frequency of smoking cessation counselling, and referral practices. 
Summarize Likert scale responses (e.g., confidence or attitude scores) using means and 
standard deviations or medians and interquartile ranges, depending on distribution. 
Comparative Analysis is used as Chi-square tests or Fisher’s exact tests (if expected counts 
are low) to compare categorical responses between different professional groups (surgeons 
vs anaesthetists vs nurses).For Likert scale or ordinal data, use ANOVA or Kruskal-Wallis 
tests to detect differences among groups. 
 
Statistical Methods 
The primary outcome will be analyzed using Chi-square tests .7-day smoking abstinence 
on the day of surgery to compare proportions between intervention and control groups 
under an intention-to-treat (ITT) approach. The Chi-square test is appropriate for 
categorical binary outcomes like abstinence rates. Parametric or non-parametric tests allow 
for continuous data handling based on distribution.   
 
Secondary continuous outcomes, such as reduction in cigarettes per day, will be analyzed 
with independent t-tests or Mann-Whitney U tests if non-normal. Postoperative 
complications will be analyzed using logistic regression to adjust for confounders such as 
age, sex, and comorbidities. Longitudinal abstinence data at 1-month will be assessed using 
survival analysis techniques like Kaplan-Meier curves and log-rank tests. Logistic 
regression adjusts for potential confounders and allows estimation of the intervention effect 
on postoperative complications. Survival analysis effectively models time-to-relapse over 
the follow-up period. 
 
9. Software: 

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Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 28 
or R software version 4.2.  
Significance Thresholds: 
A two-sided p-value of < 0.05 will be considered statistically significant. Confidence 
intervals at 95% will be reported for effect size estimates (e.g., relative risk, odds ratios). 
 
10.Human Subjects Protection 
The eligible patients will be invited to participant voluntarily. The purpose and the 
procedures of the study will be explained and informed consent will be obtained from each 
patient. The study will get approval from Hospital Authority Central Institutional Review 
Board. And will be registered with ClinicalTrails.gov. 
 
 
11.Ethical Considerations 
This study has been submitted to Hospital Authority Central Institutional Review Board 
(Central IRB) for approval. The data will be recorded in a manner that does not allow the 
participants to be identified (i.e. using a non-recognizable code). To protect privacy, all 
research data will be handled in line with HA / Hospital's policy in handling / storage / 
destruction of  medical records. Written consent will be obtained from participants and 
emphasized in the consent form that participation will be on a voluntary basis and can 
withdraw any time without penalty.  
 
Potential Risks 
Some patients may experience increased anxiety or stress when discussing their smoking 
habits and the associated risks. This could impact their overall preoperative well-being. 
Provide a supportive and empathetic environment during counseling sessions. Patients may 
be resistant to receiving smoking cessation advice, leading to feelings of frustration or 
defensiveness. Foster open communication, allowing patients to express their concerns and 
feelings regarding smoking cessation. 
 
12.Data Handling, Data Access and Record Keeping 
The hard copies of the study data will be locked in cabinet during the course of the study 
while the soft copy would be encrypted/ password-protected. The  study data will also be 
permanently deleted and unrecoverable after the 5 years storage period. IRB has the right 
to access for data monitoring propose. Only authorized research staff will have access to 
the data. Principal Investigator will be responsible for safekeeping of the personal and 
study data during and after the study.   All  patients data will be removed from the data set 
before analysis to ensure confidentiality. Exhaled carbon monoxide samples will be 
collected by research staff with a piCO Smokerlyzer (Bedfont Scientific Ltd), and saliva 
cotinine samples will be measured using a test strip (to be confirm the brand of company).  

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13.Financial Funding and Budget 
No research funding is applied and the Cotinine test kit is supported by department. The 
CO analyzer and their consumable is supported by hospital smoke cessation service.  
 
14.Indemnity and Insurance 
Nil concern about of this study is raised. 
 
 
15. Publications: 
The results of this study may be presented at scientific meetings and published in academic 
or medical journals. Any reports or publications will only use aggregated data. No 
individual participant will be identified in any publication, and no personal identifiers (such 
as name or Hong Kong Identity Card number) will be disclosed. 
 
If data obtained from the Hospital Authority databases are used, the research team will 
acknowledge the Hospital Authority in all publications and will strictly follow its 
requirements on data use and confidentiality. 
 
15. Reference:  
American Nurses Association (ANA). (2021). "Nurses' role in tobacco cessation and 
surgical outcomes." Retrieved from ANA 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 
 
Centers for Disease Control and Prevention (CDC). (2022). "The impact of smoking on 
surgical outcomes." Retrieved from CDC website. 
 
 
K. Andrews, P. Bale, J. Chu, A. Cramer, P. Aveyard (2006). A randomized controlled trial 
to assess the effectiveness of a letter from a consultant surgeon in causing smokers to stop 
smoking pre-operatively.Elsevier Public Health 120, 356-358 
 
Moore, 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. 
 

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Ng CS, Yu CWS, Leung L, et al. (2024). Economic costs of tobacco-related diseases in 
Hong Kong in 2021Tobacco Control Published Online First: . doi: 10.1136/tc-2024-
058817 
 
Rice, V. H., et al. (2020). "Nursing interventions for smoking cessation: Evidence from a 
Cochrane Review." Cochrane Database of Systematic Reviews, (12), CD001188. 
 
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. 
 
Warner, 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. 
 
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. (2016). 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;25(3):1057–1073. doi: 10.1177/0962280215588241. 
 
Wetterslev J, Hansen EG, Kamp-Jensen M, Roikjaer O, Kanstrup IL (2000).  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 ;44:9–16. 
 
Ying, X., Freedland, K. E., Powell, L. H., Stuart, E. A., Ehrhardt, S., & Mayo-Wilson, E. 
(2025). Determining sample size for pilot trials: a tutorial. BMJ (Clinical research ed.), 390, 
e083405. https://doi.org/10.1136/bmj-2024-083405