Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled trial aims to explore the impact of an Empathy-Based Program on the level of empathy among nursing assistants in a long-term care facility. A total of 100 participants will be divided into two groups: a virtual reality (VR) with debriefing group, and a control group (C) receiving routine care. The intervention involves a weekly 5-minute VR session featuring immersive experiences of residents' lives within the facility, followed by a 25-minute debriefing discussion in small groups of 5~6 participants. This will continue for three weeks. The study will evaluate the effectiveness of the empathy program in enhancing nursing assistants' empathy levels, with data collection occurring at three time points: baseline, post-intervention, and one-month follow-up.
This study aims to investigate whether an Empathy-Based Program can enhance the level of empathy among nursing assistants working in long-term care facilities. The trial will include 100 participants who will be randomly assigned to one of two groups: a virtual reality (VR) with debriefing group, and a control group (C) receiving routine care. The intervention consists of a 30-minute session once a week for three weeks, comprising a 5-minute virtual scenario video followed by a 25-minute small-group debriefing session with 5 to 6 participants.
The primary objective of the study is to assess the impact of the Empathy-Based Program on participants' empathy levels, empathic behaviors, and attitudes toward older adults. Data will be collected at multiple time points throughout the intervention, and statistical analyses will be conducted to determine the effectiveness of the empathy-based sessions.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| virtual reality (VR) with debriefing Group | Experimental | Participants in this group will engage with immersive virtual reality (VR) with debriefing. |
|
| Control Group (C) | No Intervention | Participants in this group will continue their usual care routine without additional exposure to virtual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality (VR) with Debriefing | Behavioral | Participants will receive a weekly 5-minute VR session featuring immersive experiences of residents' lives within the facility, followed by a 25-minute debriefing discussion in small groups of 5~6 participants. This will continue for three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Empathy Level | Empathy level was measured using the full, unabbreviated Jefferson Scale of Empathy-Health Professions Version (JSE-HP), which constructs and assesses the multi-dimensional empathy levels of healthcare professionals (including perspective taking, compassionate care, and standing in patient's shoes). The JSE-HP consists of 20 items answered on a 7-point Likert scale. The total score ranges from a minimum of 20 to a maximum of 140. A higher total score indicates a greater level of empathy (a better outcome), whereas a lower total score represents a worse outcome. Individual subscale scores were combined by summation to compute the final total score. | Baseline (pre-intervention), end of intervention (week 3), and follow-up at one month post-intervention (week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Attitudes Toward Older People | Attitudes toward older adults were measured using the full, unabbreviated Kogan's Attitudes Toward Older People Scale (KAOP), which constructs and assesses the positive and negative sentiments toward elderly populations. The KAOP consists of 34 items answered on a 6-point Likert scale. The total score ranges from a minimum of 34 to a maximum of 204. A higher total score indicates a more positive attitude toward older adults (a better outcome), whereas a lower total score represents a more negative attitude (a worse outcome) |
Not provided
Inclusion Criteria:
Participants must meet all of the following criteria:
Possess a valid nursing assistant license
Aged 20 years or older
Have worked at a long-term care institution for more than 3 months
Able to read and understand written Chinese
Exclusion Criteria:
Employed as a part-time nursing assistant
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University | Taipei | None Selected | 11031 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 109 individuals assessed for eligibility, six were excluded prior to assignment due to not meeting inclusion criteria (n=2), declining participation (n=3), or taking extended leave (n=1). A total of 103 participants were enrolled and assigned to study groups.
Participants were recruited from long-term care institutions in Taiwan. Six institutions were invited, four agreed to participate and provided institutional consent. A total of 109 individuals were assessed for eligibility, and 103 participants provided written informed consent prior to group assignment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Empathy Training Group | Participants from institutions assigned to receive the empathy training intervention. |
| FG001 | Usual Care Group | Participants from institutions assigned to receive an empathy manual for self-directed reading without participating in the structured empathy training intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population included all participants assigned to each study group who completed baseline assessment (T0). No participants were excluded from the baseline analysis, and the numbers are consistent with those reported in the Participant Flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group (C) | Participants in this group will continue their usual care routine without additional exposure to virtual. |
| BG001 | Virtual Reality (VR) With Debriefing Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at baseline assessment (T0). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Attitudes Toward Older People | Attitudes toward older adults were measured using the full, unabbreviated Kogan's Attitudes Toward Older People Scale (KAOP), which constructs and assesses the positive and negative sentiments toward elderly populations. The KAOP consists of 34 items answered on a 6-point Likert scale. The total score ranges from a minimum of 34 to a maximum of 204. A higher total score indicates a more positive attitude toward older adults (a better outcome), whereas a lower total score represents a more negative attitude (a worse outcome) | All participants with available data for this outcome at the specified time point were included in the analysis. | Posted | Mean | Standard Deviation | Score | Baseline (pre-intervention), end of intervention (week 3), and follow-up at one month post-intervention (week 7) |
|
From baseline (pre-intervention) through the end of the intervention (week 3) and follow-up assessment at one month post-intervention (week 7).
Adverse events were monitored throughout the study period in both groups using participant self-report and investigator observation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group (C) | Participants in this group will continue their usual care routine without additional exposure to virtual. |
Not provided
Not provided
Several limitations should be considered when interpreting the study results. First, the study was conducted in a limited number of long-term care institutions in Taiwan, which may limit the generalizability of the findings to other settings or populations. Second, outcomes were primarily measured using self-reported instruments, which may be subject to response bias. Third, the follow-up period was relatively short, and longer-term effects of the intervention could not be assessed. Finally, bli
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator (PI) | Taipei Medical University | 02-2736-1661 | 6328 | yeuhui@tmu.edu.tw |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2025 | May 22, 2026 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2025 | Feb 13, 2026 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
The outcomes assessors were masked to group assignments to reduce assessment bias. No other parties were masked.
|
| Baseline (pre-intervention), end of intervention (week 3), and follow-up at one month post-intervention (week 7) |
| Empathic Behavior | Empathic behavior was measured using a Structured Empathic Behavior Rating Scale, which constructs and evaluates observable empathic behaviors exhibited by nursing assistants during direct resident caregiving interactions. The scale utilizes a standardized checklist to rate specific behavioral interactions. The total score ranges from a minimum of 12 to a maximum of 84. A higher total score indicates a higher frequency or better quality of demonstrated empathic behaviors (a better outcome), while a lower score represents fewer or poorer empathic behaviors. | Baseline (pre-intervention), end of intervention (week 3), and follow-up at one month post-intervention (week 7) |
Participants in this group will engage with immersive virtual reality (VR) with debriefing.
| BG002 | Total | Total of all reporting groups |
All participants with available baseline age data were included in the analysis.
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex was recorded as a categorical demographic variable (female or male) at baseline. | Sex of participants at baseline assessment (T0). | Count of Participants | Participants |
|
| Jefferson Scale of Empathy-Health Professions Version (JSE-HP) Score at Baseline | Empathy was assessed at baseline (T0) using the Jefferson Scale of Empathy-Health Professions Version (JSE-HP), a validated self-report instrument for measuring empathy among health professionals. Higher scores indicate greater empathy. | All participants with available baseline empathy data were included in the analysis. | Mean | Standard Deviation | Score |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Virtual Reality (VR) With Debriefing Group | Participants in this group will engage with immersive virtual reality (VR) with debriefing. |
|
|
| Primary | Empathy Level | Empathy level was measured using the full, unabbreviated Jefferson Scale of Empathy-Health Professions Version (JSE-HP), which constructs and assesses the multi-dimensional empathy levels of healthcare professionals (including perspective taking, compassionate care, and standing in patient's shoes). The JSE-HP consists of 20 items answered on a 7-point Likert scale. The total score ranges from a minimum of 20 to a maximum of 140. A higher total score indicates a greater level of empathy (a better outcome), whereas a lower total score represents a worse outcome. Individual subscale scores were combined by summation to compute the final total score. | All participants with available data for this outcome at the specified time point were included in the analysis. | Posted | Mean | Standard Deviation | Score | Baseline (pre-intervention), end of intervention (week 3), and follow-up at one month post-intervention (week 7) |
|
|
|
| Secondary | Empathic Behavior | Empathic behavior was measured using a Structured Empathic Behavior Rating Scale, which constructs and evaluates observable empathic behaviors exhibited by nursing assistants during direct resident caregiving interactions. The scale utilizes a standardized checklist to rate specific behavioral interactions. The total score ranges from a minimum of 12 to a maximum of 84. A higher total score indicates a higher frequency or better quality of demonstrated empathic behaviors (a better outcome), while a lower score represents fewer or poorer empathic behaviors. | All randomized participants with available empathic behavior outcome data were included in the analysis. | Posted | Mean | Standard Deviation | Score | Baseline (pre-intervention), end of intervention (week 3), and follow-up at one month post-intervention (week 7) |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Virtual Reality (VR) With Debriefing Group | Participants in this group will engage with immersive virtual reality (VR) with debriefing. | 0 | 53 | 0 | 53 | 0 | 53 |
Not provided
Not provided
| End of intervention (week 3) |
|
|
| Follow-up at one month post-intervention (week 7, T2) |
|
|
| End of intervention (week 3) |
|
|
| Follow-up at one month post-intervention (week 7, T2) |
|
|