Clinical trial NCT05864339: Efficacy of a Designed Empathy Course
Official title: Efficacy of a Designed Empathy Course During Smoking Cessation Counseling Training for Nursing Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Nursing Education
Keywords: Empathy
Nursing students
Nurse
Smoking cessation counseling
training
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The changes of empathy towards smokers
timeFrame: Change from before the empathy course and immediately after the empathy course (at the same day).
measure: The changes of self-efficacy towards smoking cessation counseling
timeFrame: Change from before the tutorial, after the tutorial and 2-month follow up.
Secondary outcomes:
measure: The changes of students' attitude towards smoking cessation counseling
timeFrame: Change from before the tutorial, after the tutorial and 2-month follow up.
measure: The scores of students' 5As smoking cessation counseling skill
timeFrame: 2 weeks after the this entire course.
measure: 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.
timeFrame: Change from before the tutorial at 2-month follow up.
measure: The scores of students' satisfaction with the designed tutorial
timeFrame: Immediately after the empathy course.
measure: Qualitative measures
timeFrame: The wrap-up session during the empathy tutorial.
measure: Qualitative contents of the Health Empathy Map
timeFrame: At the end of the 2-month trial period.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Derek Yee Tak Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
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