Smoking CessationNCT05864339
Efficacy of a Designed Empathy Course
A study testing A designed empathy intervention and Smoking cessation counseling tutorial in people with Smoking Cessation and Nursing Education, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This proposed study aims to develop a designed empathy course intervention during the smoking cessation counseling (SCC) training for master nursing students at the University of Hong Kong. The objectives are: 1. To increase master nursing students' empathy towards smokers. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Nursing Education
- What is being tested?
- A designed empathy intervention and Smoking cessation counseling tutorial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 May 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Master nursing students (1-2 years)
- Students are able to read, understand, and write in both English and Cantonese
- Students are willing to participate in this study and sign the informed consent.
Who cannot join
- Students who have taken any empathy courses in the past 6 months
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong
Hong Kong
Derek Yee Tak Cheung, PhD, +852 39176652, derekcheung@hku.hk
Derek Yee Tak Cheung, PhD
About this study
Official title: Efficacy of a Designed Empathy Course During Smoking Cessation Counseling Training for Nursing Students: A Randomized Controlled Trial
This proposed study aims to develop a designed empathy course intervention during the smoking cessation counseling (SCC) training for master nursing students at the University of Hong Kong.
The objectives are:
- To increase master nursing students' empathy towards smokers.
- To increase master nursing students' self-efficacy towards SCC.
- To improve master nursing students' attitude towards SCC;
- To increase master nursing students' use of 5As counseling skill(Ask, Advise, Assess, Assist, and Arrange) during their practice.
Read the detailed description
- Background: This proposed study was designed based on Kolb's Experiential Learning Theory (ELT). Kolb defined that learning requires the acquisition of abstract concepts that can then be applied flexibly in a wide range of situations. He created the experiential learning cycle in 1974, the four-stage model views learning as an integrated process. All four stages are mutually supportive because Kolb believes that effective learning is a cyclic process that involves experiencing, reflecting, thinking, and acting. The model for experiential learning theory portrays two dialectically related modes of grasping experience (concrete experience and abstract conceptualization) and two dialectically related modes of transforming experience (reflective observation and active experimentation), which help learners transform their experience into knowledge. Each of these stages acts as a foundation for the next stage.
- Study design: This proposed study is a 2-arm, randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the empathy, self-efficacy, attitude, and practice between master nursing students of two groups who participated in the designed empathy tutorial.
- Subjects: The study targets to recruit students of Master of Nursing who are taking the course "Tobacco Dependency Nursing Intervention and Management (NURS8205)" in the spring semester, of 2023.
- Procedures of teaching intervention:
- Students in both groups will watch the a smoker's video during the empathy course and fill out the Comprehensive State Empathy Scale based on their feeling towards the smoker in the video.
- The tutor will present slides about the importance of empathy and empathy skills in the SCC (the intervention group) and instruct students on how to fill out the Health Empathy Map(HEM) ( only for the intervention group). But students in the control group will receive the presentation about 5As counseling skill and do not be instructed on how to fill out the HEM.
- Students of both groups will be further allocated to 8 small groups with 3~5 participants. During the break-out session, students will watch 4 smokers' cases (A-D) via videos and textual materials. Each student fills out 4 HEMs for 4 smokers (the intervention group). Then, each small group in both groups has to discuss and prepare a quit plan for an assigned smoker using the 5As and will present by role play.
- Each small group (both groups) will recommend two students to demonstrate the smoking cessation counseling plan using the 5As , one student will play the "nurse" role, and the other student will play the "smoker" role. Each small group has 10 minutes to present, the tutor and other students can comment and feedback after each small group's presentation.
- After all presentations of the 8 small groups, the tutor will organize a focus group interview and instruct the students to complete the post-questionnaire at the end of the tutorial. Focus groups interview will be audio recorded while a research assistant served as a scribe.
- Sample size calculate Sample size will be determined based on a G*Power analysis, using the t-test, to measure the difference between two independent means (two groups) to achieve a medium effect size of 0.8, A minimum sample size of 54 nursing students will be needed to achieve a power of 70% at 0.05 level of two-sided significance. To reach a meaningful result from the analysis of data, we added a buffer of 6 additional students (N = 60) to ensure the validity and robustness of the results.
- Randomization and blinding The computer random number generator "Research Randomizer" will be used in the sequence generation process to generate a random sample using the block randomization technique. The single-blinding technique will be used to conceal the allocation. Participants will not know if they are given the conventional tutorials or the newly designed empathy tutorials.
- Consent Students will receive an invitation email from the primary investigator and complete informed consent before the empathy course.
- Statistical analysis Data will be entered into SPSS for Windows (version 20) for analysis. Descriptive statistics including frequency, percentage, and mean will be used to summarize the outcomes and other variables. By intention-to-treat analysis, participants who are lost or refuse the follow-up will be treated as having no change in the training outcomes. Chi-square tests and t-tests will be used to compare the outcomes between intervention and control groups. The effect size, Cohen's d, of the standardized mean of the pre-post differences will be computed, with and without adjustment for baseline characteristics. Linear mixed models which allow for multiple observations between subjects and account for the clustering of data within subjects will be used to assess the intervention effect on empathy, self-efficacy, attitude, and practice. Both the main effect (group allocation) and interaction effect (group X time) will be analyzed. To integrate and complement the obtained results, a qualitative analysis of the HEMs and focus group interview were performed using the content analysis technique, categorical modality, which is based on the decoding of a text into several elements that are then classified and form thematic groups that help to understand and describe the content of the messages.
- Conditions
- Smoking Cessation, Nursing Education
- Being tested
- A designed empathy intervention, Smoking cessation counseling tutorial
- Keywords
- Empathy, Nursing students, Nurse, Smoking cessation counseling, training
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A designed empathy interventionBehavioural
Students watch 4 smokers' videos, read the textual materials, fill out the HEMs and discuss a quit counseling plan for an assigned smoker using the 5As counseling skilll.
Smoking cessation counseling tutorialBehavioural
Students watch 4 smokers' videos, read the textual materials, and discuss a quit counseling plan for an assigned smoker using the 5As counseling skill.
| Study group | Role | What they receive |
|---|---|---|
| A designed empathy tutorial during the SCC course (Intervention group) | Experimental | Students who participated in the designed empathy tutorial (viewing videos of four smokers' real-life scenarios, reading four smokers cases text materials, and drawing Health Empathy Map). Students will demonstrate a quit plan by role-playing and will attend focus group interviews during the wrap-up session. Receives: Behavioral: A designed empathy intervention |
| Smoking cessation counseling tutorial (Control group) | Active comparator | Students will watch videos of four smokers' real-life scenarios, and read four smokers' case text materials. Students will demonstrate a quit plan by role-playing and will attend focus group interviews during the wrap-up session. Receives: Behavioral: Smoking cessation counseling tutorial |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of empathy towards smokers
The Comprehensive State Empathy Scale will be used to evaluate the master nursing students' empathy towards smokers. This scale has 30 items, each item is scored using a five-point Likert scale with response ranges from 1 (completely untrue) to 5 (completely true), with higher scores reflecting higher empathy levels, with the total scores ranging from 30 to 150 points.The higher score means the higher empathy.
Measured: Change from before the empathy course and immediately after the empathy course (at the same day).
The changes of self-efficacy towards smoking cessation counseling
The sub-scale Self-efficacy of the Providers Smoking Cessation Training Evaluation will be used to assess the students' self-efficacy towards smoking cessation counseling. The total score ranges from 13 to 65 points, the higher score means the higher self-efficacy.
Measured: Change from before the tutorial, after the tutorial and 2-month follow up.
Secondary outcomes (6)
The changes of students' attitude towards smoking cessation counseling
The attitude sub-scale of The Providers Smoking Cessation Training Evaluation will be used to assess the students' attitude towards smoking cessation counseling.The total score ranges from 8 to 40 points, the higher score means the higher attitude.
Measured: Change from before the tutorial, after the tutorial and 2-month follow up.
The scores of students' 5As smoking cessation counseling skill
The scores of the students' practical examination will be used to evaluate 5As smoking cessation counseling skill level that they have acquired.The total score ranges from 0 to 100 points, the higher score means the higher 5As skill.
Measured: 2 weeks after the this entire course.
The changes of students' practical behavior of smoking cessation counseling skill during their clinical workplace.The total score ranges from 8 to 40 points, the higher score means the higher attitude.
The behavior sub-scale of The Providers Smoking Cessation Training Evaluation will be used to assess the students' practical behavior of smoking cessation counseling.The total score ranges from 19 to 95 points, the higher score means the higher practical behavior.
Measured: Change from before the tutorial at 2-month follow up.
The scores of students' satisfaction with the designed tutorial
The 'Satisfaction' sub-scale from the Student Satisfaction and Self-Confidence in Learning Simulation will be revised to measure nursing students' satisfaction with the designed tutorial.The total score ranges from 5 to 25 points, the higher score means the higher satisfaction.
Measured: Immediately after the empathy course.
Qualitative measures
Students will attend a focus group interview during the wrap-up session, and the following questions will be discussed: a)What are your personal experiences towards smokers in those videos? b)What comes to you mind when the smokers have quitting barriers in the videos. c)Do you think nurses should show empathy to smokers during the counseling? Why or why not ? d)What factors would affect your empathy towards smokers? e)What are some of the things nurses do when they show empathy towards smokers during the counseling? f)Do you think empathy levels in someone can be changed? Or is it inborn, meaning it cannot be taught. g)Please share you attitude, self-efficacy, and practice towards help smokers patients to quit after this training. h)Before ending the session, any more to you would like to share with us, about the tutorial or any others?
Measured: The wrap-up session during the empathy tutorial.
Qualitative contents of the Health Empathy Map
The content analysis technique will be used to analysis the sentences on the Health Empathy Map that written by students.
Measured: At the end of the 2-month trial period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start25 May 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Model description
- This study was designed based on Kolb's Experiential Learning Theory (ELT). This study is a 2-arm, randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the empathy, self-efficacy, skill, attitude, and practice between master nursing students who participated in the designed empathy tutorial (viewing videos of four smokers' real-life scenarios, reading four smokers cases text materials, and drawing Health Empathy Map) (intervention group) and those who participated in a conventional tutorial (viewing videos of four smokers' real-life scenarios, reading four smokers cases text materials) (control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Derek Yee-Tak Cheung, The University of Hong Kong
- Investigators
- Derek Yee Tak Cheung, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864339
- Sponsor's protocol ID
- Empathy course protocol-v1
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data and documentation will be available upon request.
Publications
Bas-Sarmiento P, Fernandez-Gutierrez M, Baena-Banos M, Romero-Sanchez JM. Efficacy of empathy training in nursing students: A quasi-experimental study. Nurse Educ Today. 2017 Dec;59:59-65. doi: 10.1016/j.nedt.2017.08.012. Epub 2017 Sep 8.
PubMed 28945994Batt-Rawden SA, Chisolm MS, Anton B, Flickinger TE. Teaching empathy to medical students: an updated, systematic review. Acad Med. 2013 Aug;88(8):1171-7. doi: 10.1097/ACM.0b013e318299f3e3.
PubMed 23807099Cheung YTD, Chan CHH, Ho KS, Tang C, Lau CWH, Li WHC, Wang MP, Lam TH. Effectiveness of nicotine replacement therapy sample at outdoor smoking hotspots for initiating quit attempts and use of smoking cessation services: a protocol for a cluster randomised controlled trial. BMJ Open. 2020 Apr 7;10(4):e036339. doi: 10.1136/bmjopen-2019-036339.
PubMed 32269028Chun CK, Wong FK, Wang SL, Chen W. Examining advanced nursing practice in Hong Kong and Guangzhou. Int J Nurs Sci. 2021 Mar 5;8(2):190-198. doi: 10.1016/j.ijnss.2021.03.001. eCollection 2021 Apr 10.
PubMed 33997133Duaso MJ, Bakhshi S, Mujika A, Purssell E, While AE. Nurses' smoking habits and their professional smoking cessation practices. A systematic review and meta-analysis. Int J Nurs Stud. 2017 Feb;67:3-11. doi: 10.1016/j.ijnurstu.2016.10.011. Epub 2016 Nov 2.
PubMed 27880873Gholamzadeh S, Khastavaneh M, Khademian Z, Ghadakpour S. The effects of empathy skills training on nursing students' empathy and attitudes toward elderly people. BMC Med Educ. 2018 Aug 15;18(1):198. doi: 10.1186/s12909-018-1297-9.
PubMed 30111312Hasan SI, Mohd Hairi F, Ahmad Tajuddin NA, Amer Nordin AS. Empowering healthcare providers through smoking cessation training in Malaysia: a preintervention and postintervention evaluation on the improvement of knowledge, attitude and self-efficacy. BMJ Open. 2019 Sep 27;9(9):e030670. doi: 10.1136/bmjopen-2019-030670.
PubMed 31562154Hasan SI, Mohd Hairi F, Amer Nordin AS, Danaee M. Development and Validation of an Evaluation Tool to Measure the Effectiveness of a Smoking Cessation Training among Healthcare Providers in Malaysia: The Providers' Smoking Cessation Training Evaluation (ProSCiTE). Int J Environ Res Public Health. 2019 Nov 5;16(21):4297. doi: 10.3390/ijerph16214297.
PubMed 31694286Levett-Jones T, Cant R, Lapkin S. A systematic review of the effectiveness of empathy education for undergraduate nursing students. Nurse Educ Today. 2019 Apr;75:80-94. doi: 10.1016/j.nedt.2019.01.006. Epub 2019 Jan 26.
PubMed 30739841Luo YF, Chen LC, Yang SC, Hong S. Knowledge, Attitude, and Practice (KAP) toward COVID-19 Pandemic among the Public in Taiwan: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Feb 27;19(5):2784. doi: 10.3390/ijerph19052784.
PubMed 35270491Patterson J, Duke G, Stocks E, Hermanns M. Simulation to Enhance Empathy of Nursing Students Toward Patients With Alcohol Use Disorder: A Mixed-Methods Study. Nurse Educ. 2020 Nov/Dec;45(6):331-335. doi: 10.1097/NNE.0000000000000804.
PubMed 31972845Harizi C, El-Awa F, Ghedira H, Audera-Lopez C, Fakhfakh R. Implementation of the WHO Framework Convention on Tobacco Control in Tunisia: Progress and challenges. Tob Prev Cessat. 2020 Dec 22;6:72. doi: 10.18332/tpc/130476. eCollection 2020.
PubMed 33426382Zhang G, Luk TT, Lam VSF, Zhao S, Yip AON, Wang MP, Chan SSC, Cheung YTD. Effectiveness of a theory-based empathy enhancement in increasing Master of Nursing students' empathy and practice of smoking cessation intervention: A randomized controlled trial. Nurse Educ Pract. 2025 Aug;87:104483. doi: 10.1016/j.nepr.2025.104483. Epub 2025 Jul 23.
PubMed 40714657
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Designed Empathy Course During Smoking Cessation Counseling Training for Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05864339
- Acronym / sponsor ID
- Empathy course protocol-v1
- Conditions
- Smoking Cessation, Nursing Education
- Keywords
- Empathy, Nursing students, Nurse, Smoking cessation counseling, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 25 May 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 18 May 2023 (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.
This proposed study aims to develop a designed empathy course intervention during the smoking cessation counseling (SCC) training for master nursing students at the University of Hong Kong.
The objectives are:
- To increase master nursing students' empathy towards smokers.
- To increase master nursing students' self-efficacy towards SCC.
- To improve master nursing students' attitude towards SCC;
- To increase master nursing students' use of 5As counseling skill(Ask, Advise, Assess, Assist, and Arrange) during their practice.
Detailed description
- Background: This proposed study was designed based on Kolb's Experiential Learning Theory (ELT). Kolb defined that learning requires the acquisition of abstract concepts that can then be applied flexibly in a wide range of situations. He created the experiential learning cycle in 1974, the four-stage model views learning as an integrated process. All four stages are mutually supportive because Kolb believes that effective learning is a cyclic process that involves experiencing, reflecting, thinking, and acting. The model for experiential learning theory portrays two dialectically related modes of grasping experience (concrete experience and abstract conceptualization) and two dialectically related modes of transforming experience (reflective observation and active experimentation), which help learners transform their experience into knowledge. Each of these stages acts as a foundation for the next stage.
- Study design: This proposed study is a 2-arm, randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the empathy, self-efficacy, attitude, and practice between master nursing students of two groups who participated in the designed empathy tutorial.
- Subjects: The study targets to recruit students of Master of Nursing who are taking the course "Tobacco Dependency Nursing Intervention and Management (NURS8205)" in the spring semester, of 2023.
- Procedures of teaching intervention:
- Students in both groups will watch the a smoker's video during the empathy course and fill out the Comprehensive State Empathy Scale based on their feeling towards the smoker in the video.
- The tutor will present slides about the importance of empathy and empathy skills in the SCC (the intervention group) and instruct students on how to fill out the Health Empathy Map(HEM) ( only for the intervention group). But students in the control group will receive the presentation about 5As counseling skill and do not be instructed on how to fill out the HEM.
- Students of both groups will be further allocated to 8 small groups with 3~5 participants. During the break-out session, students will watch 4 smokers' cases (A-D) via videos and textual materials. Each student fills out 4 HEMs for 4 smokers (the intervention group). Then, each small group in both groups has to discuss and prepare a quit plan for an assigned smoker using the 5As and will present by role play.
- Each small group (both groups) will recommend two students to demonstrate the smoking cessation counseling plan using the 5As , one student will play the "nurse" role, and the other student will play the "smoker" role. Each small group has 10 minutes to present, the tutor and other students can comment and feedback after each small group's presentation.
- After all presentations of the 8 small groups, the tutor will organize a focus group interview and instruct the students to complete the post-questionnaire at the end of the tutorial. Focus groups interview will be audio recorded while a research assistant served as a scribe.
- Sample size calculate Sample size will be determined based on a G*Power analysis, using the t-test, to measure the difference between two independent means (two groups) to achieve a medium effect size of 0.8, A minimum sample size of 54 nursing students will be needed to achieve a power of 70% at 0.05 level of two-sided significance. To reach a meaningful result from the analysis of data, we added a buffer of 6 additional students (N = 60) to ensure the validity and robustness of the results.
- Randomization and blinding The computer random number generator "Research Randomizer" will be used in the sequence generation process to generate a random sample using the block randomization technique. The single-blinding technique will be used to conceal the allocation. Participants will not know if they are given the conventional tutorials or the newly designed empathy tutorials.
- Consent Students will receive an invitation email from the primary investigator and complete informed consent before the empathy course.
- Statistical analysis Data will be entered into SPSS for Windows (version 20) for analysis. Descriptive statistics including frequency, percentage, and mean will be used to summarize the outcomes and other variables. By intention-to-treat analysis, participants who are lost or refuse the follow-up will be treated as having no change in the training outcomes. Chi-square tests and t-tests will be used to compare the outcomes between intervention and control groups. The effect size, Cohen's d, of the standardized mean of the pre-post differences will be computed, with and without adjustment for baseline characteristics. Linear mixed models which allow for multiple observations between subjects and account for the clustering of data within subjects will be used to assess the intervention effect on empathy, self-efficacy, attitude, and practice. Both the main effect (group allocation) and interaction effect (group X time) will be analyzed. To integrate and complement the obtained results, a qualitative analysis of the HEMs and focus group interview were performed using the content analysis technique, categorical modality, which is based on the decoding of a text into several elements that are then classified and form thematic groups that help to understand and describe the content of the messages.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was designed based on Kolb's Experiential Learning Theory (ELT). This study is a 2-arm, randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the empathy, self-efficacy, skill, attitude, and practice between master nursing students who participated in the designed empathy tutorial (viewing videos of four smokers' real-life scenarios, reading four smokers cases text materials, and drawing Health Empathy Map) (intervention group) and those who participated in a conventional tutorial (viewing videos of four smokers' real-life scenarios, reading four smokers cases text materials) (control group).
| Arm | Type | Receives |
|---|---|---|
| A designed empathy tutorial during the SCC course (Intervention group) | Experimental | Behavioral: A designed empathy interventionStudents who participated in the designed empathy tutorial (viewing videos of four smokers' real-life scenarios, reading four smokers cases text materials, and drawing Health Empathy Map). Students will demonstrate a quit plan by role-playing and will attend focus group interviews during the wrap-up session. |
| Smoking cessation counseling tutorial (Control group) | Active comparator | Behavioral: Smoking cessation counseling tutorialStudents will watch videos of four smokers' real-life scenarios, and read four smokers' case text materials. Students will demonstrate a quit plan by role-playing and will attend focus group interviews during the wrap-up session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Master nursing students (1-2 years)
- Students are able to read, understand, and write in both English and Cantonese
- Students are willing to participate in this study and sign the informed consent.
Key exclusion criteria (1 listed)
- Students who have taken any empathy courses in the past 6 months
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 |
|---|---|---|
| A designed empathy interventionStudents watch 4 smokers' videos, read the textual materials, fill out the HEMs and discuss a quit counseling plan for an assigned smoker using the 5As counseling skilll. | Behavioural | A designed empathy tutorial during the SCC course (Intervention group) |
| Smoking cessation counseling tutorialStudents watch 4 smokers' videos, read the textual materials, and discuss a quit counseling plan for an assigned smoker using the 5As counseling skill. | Behavioural | Smoking cessation counseling tutorial (Control group) |
Primary outcome
The changes of empathy towards smokers
Time frame: Change from before the empathy course and immediately after the empathy course (at the same day).
The Comprehensive State Empathy Scale will be used to evaluate the master nursing students' empathy towards smokers. This scale has 30 items, each item is scored using a five-point Likert scale with response ranges from 1 (completely untrue) to 5 (completely true), with higher scores reflecting higher empathy levels, with the total scores ranging from 30 to 150 points.The higher score means the higher empathy.
The changes of self-efficacy towards smoking cessation counseling
Time frame: Change from before the tutorial, after the tutorial and 2-month follow up.
The sub-scale Self-efficacy of the Providers Smoking Cessation Training Evaluation will be used to assess the students' self-efficacy towards smoking cessation counseling. The total score ranges from 13 to 65 points, the higher score means the higher self-efficacy.
6 secondary outcomes
The changes of students' attitude towards smoking cessation counseling
Time frame: Change from before the tutorial, after the tutorial and 2-month follow up.
The scores of students' 5As smoking cessation counseling skill
Time frame: 2 weeks after the this entire course.
The changes of students' practical behavior of smoking cessation counseling skill during their clinical workplace.The total score ranges from 8 to 40 points, the higher score means the higher attitude.
Time frame: Change from before the tutorial at 2-month follow up.
The scores of students' satisfaction with the designed tutorial
Time frame: Immediately after the empathy course.
Qualitative measures
Time frame: The wrap-up session during the empathy tutorial.
Qualitative contents of the Health Empathy Map
Time frame: At the end of the 2-month trial period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Results publication: PubMed 28945994Bas-Sarmiento P, Fernandez-Gutierrez M, Baena-Banos M, Romero-Sanchez JM. Efficacy of empathy training in nursing students: A quasi-experimental study. Nurse Educ Today. 2017 Dec;59:59-65. doi: 10.1016/j.nedt.2017.08.012. Epub 2017 Sep 8.
- Results publication: PubMed 23807099Batt-Rawden SA, Chisolm MS, Anton B, Flickinger TE. Teaching empathy to medical students: an updated, systematic review. Acad Med. 2013 Aug;88(8):1171-7. doi: 10.1097/ACM.0b013e318299f3e3.
- Results publication: PubMed 32269028Cheung YTD, Chan CHH, Ho KS, Tang C, Lau CWH, Li WHC, Wang MP, Lam TH. Effectiveness of nicotine replacement therapy sample at outdoor smoking hotspots for initiating quit attempts and use of smoking cessation services: a protocol for a cluster randomised controlled trial. BMJ Open. 2020 Apr 7;10(4):e036339. doi: 10.1136/bmjopen-2019-036339.
- Results publication: PubMed 33997133Chun CK, Wong FK, Wang SL, Chen W. Examining advanced nursing practice in Hong Kong and Guangzhou. Int J Nurs Sci. 2021 Mar 5;8(2):190-198. doi: 10.1016/j.ijnss.2021.03.001. eCollection 2021 Apr 10.
- Results publication: PubMed 27880873Duaso MJ, Bakhshi S, Mujika A, Purssell E, While AE. Nurses' smoking habits and their professional smoking cessation practices. A systematic review and meta-analysis. Int J Nurs Stud. 2017 Feb;67:3-11. doi: 10.1016/j.ijnurstu.2016.10.011. Epub 2016 Nov 2.
- Results publication: PubMed 30111312Gholamzadeh S, Khastavaneh M, Khademian Z, Ghadakpour S. The effects of empathy skills training on nursing students' empathy and attitudes toward elderly people. BMC Med Educ. 2018 Aug 15;18(1):198. doi: 10.1186/s12909-018-1297-9.
- Results publication: PubMed 31562154Hasan SI, Mohd Hairi F, Ahmad Tajuddin NA, Amer Nordin AS. Empowering healthcare providers through smoking cessation training in Malaysia: a preintervention and postintervention evaluation on the improvement of knowledge, attitude and self-efficacy. BMJ Open. 2019 Sep 27;9(9):e030670. doi: 10.1136/bmjopen-2019-030670.
- Results publication: PubMed 31694286Hasan SI, Mohd Hairi F, Amer Nordin AS, Danaee M. Development and Validation of an Evaluation Tool to Measure the Effectiveness of a Smoking Cessation Training among Healthcare Providers in Malaysia: The Providers' Smoking Cessation Training Evaluation (ProSCiTE). Int J Environ Res Public Health. 2019 Nov 5;16(21):4297. doi: 10.3390/ijerph16214297.
- Results publication: PubMed 30739841Levett-Jones T, Cant R, Lapkin S. A systematic review of the effectiveness of empathy education for undergraduate nursing students. Nurse Educ Today. 2019 Apr;75:80-94. doi: 10.1016/j.nedt.2019.01.006. Epub 2019 Jan 26.
- Results publication: PubMed 35270491Luo YF, Chen LC, Yang SC, Hong S. Knowledge, Attitude, and Practice (KAP) toward COVID-19 Pandemic among the Public in Taiwan: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Feb 27;19(5):2784. doi: 10.3390/ijerph19052784.
- Results publication: PubMed 31972845Patterson J, Duke G, Stocks E, Hermanns M. Simulation to Enhance Empathy of Nursing Students Toward Patients With Alcohol Use Disorder: A Mixed-Methods Study. Nurse Educ. 2020 Nov/Dec;45(6):331-335. doi: 10.1097/NNE.0000000000000804.
- Results publication: PubMed 33426382Harizi C, El-Awa F, Ghedira H, Audera-Lopez C, Fakhfakh R. Implementation of the WHO Framework Convention on Tobacco Control in Tunisia: Progress and challenges. Tob Prev Cessat. 2020 Dec 22;6:72. doi: 10.18332/tpc/130476. eCollection 2020.
- Individual participant dataSharing planned: Yes. Research data and documentation will be available upon request.
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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. This study is not recruiting at the moment.
Derek Yee Tak Cheung, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A designed empathy intervention and Smoking cessation counseling tutorial in people with Smoking Cessation and Nursing Education, run by The University of Hong Kong 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 1 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: status not confirmed, as of the sponsor's last update on 18 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek Yee Tak Cheung, PhD (+852 39176652, derekcheung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of empathy towards smokers (time frame: Change from before the empathy course and immediately after the empathy course (at the same day).). The study lists 2 primary outcomes in all. 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 NCT05864339, which also lists 13 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 18 May 2023.