The Effectiveness of Empathy-Based Program on Empathy Level Among Nursing Assistants in Long-term Care Facility
Phase: NA
Conditions: Long-Term Care, Long-term Care Facility
Sponsor: Taipei Medical University

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Study Protocol 
Title: 
Effects of a Virtual Reality–Based Empathy Program on Empathy, Attitudes 
Toward Older Adults, and Empathic Behavior Among Nursing Assistants: A 
Cluster Randomized Controlled Trial 
NCT No.: NCT07044492 
Protocol Version: 4.0 
Date: October 13, 2025 
IRB Approval: Taipei Medical University Joint Institutional Review Board 
IRB No.: N202203004 
Principal Investigator: Principal Investigator (PI) 
 
1. Background and Rationale 
Empathy is a fundamental component of high-quality long-term care and is 
associated with improved interpersonal relationships, communication, and 
emotional well-being among older adults. Nursing assistants (NAs) provide 
the majority of direct daily care in long-term care institutions and play a 
critical role in empathic caregiving interactions. However, conventional 
empathy training approaches are often didactic in nature and may have 
limited impact on sustained empathic outcomes. 
Virtual reality (VR)–based training provides immersive, first-person 
experiential learning that may enhance perspective-taking and emotional 
engagement. When combined with structured reflective debriefing, 
VR-based interventions have the potential to improve empathy-related 
outcomes, including empathic attitudes and observable empathic behaviors. 

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This study evaluated the effectiveness of a VR-based empathy program with 
structured debriefing among nursing assistants working in long-term care 
settings, using a cluster randomized controlled trial design. 
2. Objectives and Hypotheses 
2.1 Primary Objective 
To examine the effect of a virtual reality–based empathy training 
program on empathy level among nursing assistants. 
2.2 Secondary Objectives 
1. To evaluate changes in attitudes toward older adults. 
2. To assess changes in empathic behavior over time. 
2.3 Hypothesis 
Nursing assistants in the intervention group will show significantly higher 
empathic behavior scores over time compared with the control group. 
3. Study Design 
This study was a two-arm, parallel-group, cluster randomized controlled 
trial (cluster RCT). 
Clusters were defined as care building or floor level within long-term care 
institutions. 
Eligible clusters were randomized in a 1:1 ratio to either: 
• Virtual Reality (VR) with Structured Debriefing Group, or 
• Control Group. 
Outcome assessments were conducted at three time points: 
• Baseline (pre-intervention), 
• End of intervention (week 3), and 
• Follow-up at one month post-intervention (week 7). 

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4. Study Setting 
The study was conducted in long-term care institutions in Taiwan. Clusters 
were defined as care units at the building or floor level within institutions. 
All interventions and outcome assessments were implemented within 
participating. 
5. Participants 
5.1 Inclusion Criteria 
Participants were eligible if they met all of the following criteria: 
• Certified nursing assistants 
• Aged 20 years or older 
• Employed in the current institution for at least three months 
• Able to communicate in Mandarin Chinese 
• Provided written informed consent to participate 
5.2 Exclusion Criteria 
• Currently on long-term leave during the intervention period 
• Severe visual, auditory, or cognitive impairment preventing 
participation in VR training 
6. Randomization and Allocation 
Clusters (care units/wards) were randomly assigned in a 1:1 ratio to either: 
• Control Group (C) 
• Virtual Reality (VR) with Debriefing Group 
Randomization was conducted by an independent researcher not involved in 
recruitment or assessment. 
7. Intervention 
7.1 Control Group 

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Participants in the control group received routine education or standard 
practice during the study period and were provided with an empathy manual, 
but did not receive the VR-based empathy program. 
7.2 VR With Debriefing Group 
Participants in the intervention group received a virtual reality–based 
empathy training program designed to simulate the lived experiences of 
older adults in long-term care contexts. Each VR session was followed by a 
structured debriefing session facilitated by trained personnel, focusing on 
emotional reflection, perspective-taking, and application to daily caregiving 
practice. 
The intervention was delivered over a three-week period. 
8. Outcome Measures 
8.1 Primary Outcome 
Empathy Level 
Measured using the Jefferson Scale of Empathy–Health Professions 
Version (JSE-HP). 
Higher scores indicate greater empathy. 
8.2 Secondary Outcomes 
Attitudes Toward Older Adults 
Measured using the Kogan’s Attitudes Toward Older People Scale 
(KAOP). 
Empathic Behavior 
Measured using a structured empathic behavior rating scale assessing 
observable empathic behaviors during caregiving interactions. 
8.3 Timing of Assessments 

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All outcomes were assessed at: 
• Baseline (pre-intervention), 
• End of intervention (week 3), and 
• Follow-up at one month post-intervention (week 7). 
9. Data Collection Procedures 
Data were collected using standardized questionnaires administered by 
trained research assistants. All assessors were blinded to group allocation 
where feasible. 
10. Sample Size 
A total of 103 nursing assistants participated in the study: 
• Control Group: 50 participants 
• VR with Debriefing Group: 53 participants 
11. Adverse Events 
The intervention was educational and non-invasive. Adverse events were 
monitored throughout the study period using participant self-report and 
investigator observation. No adverse events were observed or reported in 
either study group. 
12. Ethics and Informed Consent 
The study was conducted in accordance with ethical principles for research 
involving human participants. The study protocol was reviewed and 
approved by the Institutional Review Board of Taipei Medical University 
(TMU-JIRB approval number: N202203004). All procedures were 
conducted in accordance with relevant ethical guidelines and regulations. 
Written informed consent was obtained from all participants prior to 
participation. 

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13. Data Management and Confidentiality 
All data were de-identified prior to analysis. Study data were securely stored 
and accessed only by authorized research personnel. 
14. Limitations 
Limitations of the study include the limited number of participating 
institutions, reliance on self-reported measures, a relatively short follow-up 
period, and the inability to blind participants due to the nature of the 
intervention. 
15. Protocol Status 
This protocol was prepared retrospectively for results reporting purposes. 
All reported analyses and outcomes reflect the procedures actually 
implemented in the completed study.