NCT05864339

Brief 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. 1.To increase master nursing students' empathy towards smokers.
  2. 2.To increase master nursing students' self-efficacy towards SCC.
  3. 3.To improve master nursing students' attitude towards SCC;
  4. 4.To increase master nursing students' use of 5As counseling skill(Ask, Advise, Assess, Assist, and Arrange) during their practice.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

April 24, 2023

Last Update Submit

May 8, 2023

Conditions

Smoking CessationNursing Education

Keywords

EmpathyNursing studentsNurseSmoking cessation counselingtraining

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    Change from before the tutorial, after the tutorial and 2-month follow up.

  • The scores of students' 5As smoking cessation counseling skill

    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.

    Change from before the tutorial at 2-month follow up.

  • The scores of students' satisfaction with the designed tutorial

    Immediately after the empathy course.

  • Qualitative measures

    The wrap-up session during the empathy tutorial.

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Smoking cessation counseling tutorial

Interventions

A designed empathy interventionBEHAVIORAL

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.

A designed empathy tutorial during the SCC course (Intervention group)
Smoking cessation counseling tutorialBEHAVIORAL

Students watch 4 smokers' videos, read the textual materials, and discuss a quit counseling plan for an assigned smoker using the 5As counseling skill.

Smoking cessation counseling tutorial (Control group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Students who have taken any empathy courses in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (13)

  • 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.

    PMID: 28945994RESULT

  • Batt-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.

    PMID: 23807099RESULT

  • Cheung 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.

    PMID: 32269028RESULT

  • Chun 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.

    PMID: 33997133RESULT

  • Duaso 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.

    PMID: 27880873RESULT

  • Gholamzadeh 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.

    PMID: 30111312RESULT

  • Hasan 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.

    PMID: 31562154RESULT

  • Hasan 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.

    PMID: 31694286RESULT

  • Levett-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.

    PMID: 30739841RESULT

  • Luo 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.

    PMID: 35270491RESULT

  • Patterson 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.

    PMID: 31972845RESULT

  • Harizi 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.

    PMID: 33426382RESULT

  • Zhang 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.

    PMID: 40714657DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Derek Yee Tak Cheung, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek Yee Tak Cheung, PhD

CONTACT

+852 39176652derekcheung@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know if they are given the the conventional tutorials or the newly designed empathy tutorials.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 18, 2023

Study Start

May 25, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Research data and documentation will be available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available for 10 years.

Locations

HK(1)