NCT05482984

Brief Summary

Objectives: To examine the differences in nursing student empathy, caring behaviour, and competence between the experimental and control groups before and after educational intervention, and to predict the factors affecting their core competencies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 16, 2022

Last Update Submit

July 28, 2022

Conditions

Keywords

empathycaring behaviornursing competencerole playreflection

Outcome Measures

Primary Outcomes (1)

  • Change from Nursing Student Competence Scale

    The Nursing Student Competence Scale was used to measure students' nursing competence (Huang et al., 2022). Total scale scores ranged from 30 to 150. Higher scores indicate better nursing competence.

    Baseline data were collected 1 week prior to the intervention study. The second data were collected 1 week after the implementation of the intervention and up to 2 weeks.

Secondary Outcomes (2)

  • Change from Jefferson Scale of Empathy- Healthcare Providers

    Baseline data were collected 1 week prior to the intervention study. The second data were collected 1 week after the implementation of the intervention and up to 2 weeks.

  • Change from Caring Behaviours Scale

    Baseline data were collected 1 week prior to the intervention study. The second data were collected 1 week after the implementation of the intervention and up to 2 weeks.

Study Arms (2)

Lectures with video-recorded role-play and guided reflection

EXPERIMENTAL

The learning method used with the intervention group was role-playing with videos and guided reflection.

Other: video-recorded role-play and guided reflection

Lectures without video-recorded role-play and guided reflection

NO INTERVENTION

The control group was exposed to classroom lectures without video-recorded role-play and guided reflection.

Interventions

The experimental group was divided into 6 teams. Before the course, the teacher in charge and each group developed six scenarios: restraint, suicidal intent, respiratory distress, chronic heart failure, medication refusal, and accidental amputation. The researcher guided each group to write scripts about the clinical situations (30 minutes), create role-play videos (50 minutes), and share literature that was helpful in understanding this context (30 minutes). Each student played a role in the filming process. The final film was viewed by all the students during class. Each live class session was 50 minutes in length, with one session per week for 6 weeks. All students were asked to attend six video-viewing sessions and participate in a reflective discussion.

Lectures with video-recorded role-play and guided reflection

Eligibility Criteria

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

You may qualify if:

  • (1) Students who were first-year nursing students at college,
  • (2) could communicate using Mandarin or Taiwanese,
  • (3) were willing to participate in this study and agreed to cooperate with the completion of the questionnaire.

You may not qualify if:

  • deafness or a diagnosis of cognitive disorder according to various information sources, such as school health information and notification from parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

Study Officials

  • Sheng-Miauh Huang, PhD

    Mackay Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The investigators used a two-group pretest and post-test quasi-experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researchers

Study Record Dates

First Submitted

July 16, 2022

First Posted

August 1, 2022

Study Start

February 1, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations