Efficacy of a Designed Empathy Course

May 8, 2023 updated by: Dr. Derek Yee-Tak Cheung, The University of Hong Kong

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:

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. 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.

  3. 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.

  4. Procedures of teaching intervention:

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
  5. 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.
  6. 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.
  7. Consent Students will receive an invitation email from the primary investigator and complete informed consent before the empathy course.
  8. 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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
        • Contact:
        • Principal Investigator:
          • Derek Yee Tak Cheung, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A designed empathy tutorial during the SCC course (Intervention group)
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
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.
Active Comparator: Smoking cessation counseling tutorial (Control group)
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
Students watch 4 smokers' videos, read the textual materials, and discuss a quit counseling plan for an assigned smoker using the 5As counseling skill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Change from before the tutorial, after the tutorial and 2-month follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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.
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 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.
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 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.
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.
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.
Immediately after the empathy course.
Qualitative measures
Time Frame: The wrap-up session during the empathy tutorial.
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?
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.
The content analysis technique will be used to analysis the sentences on the Health Empathy Map that written by students.
At the end of the 2-month trial period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Derek Yee Tak CHEUNG, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2023

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Empathy course protocol-v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research data and documentation will be available upon request.

IPD Sharing Time Frame

Data will be available for 10 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on A designed empathy intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe