UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060075 |
|---|---|
| Receipt number | R000068683 |
| Scientific Title | A pilot randomized controlled trial of a virtual reality program to reduce compassion fatigue among cancer care nurses |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/12 18:14:33 |
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Basic information
Public title
Effect of a virtual reality program on reducing compassion fatigue among cancer care nurses
Acronym
Effect of a VR program on compassion fatigue among cancer care nurses
Scientific Title
A pilot randomized controlled trial of a virtual reality program to reduce compassion fatigue among cancer care nurses
Scientific Title:Acronym
A pilot RCT of a VR program to reduce compassion fatigue among cancer care nurses
Region
| Japan |
Condition
Condition
compassion fatigue
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to implement a psychoeducational and self-dialogue program using virtual reality among cancer care nurses and to evaluate its feasibility and effectiveness in reducing compassion fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Professional Quality of Life Scale for Japanese Nurses (ProQOL-JN; Fukumori et al., 2018) will be administered at baseline, and at 30 and 60 days after the intervention. This scale is the Japanese version of the Professional Quality of Life Scale Version 5 (ProQOL-5; Stamm, 2010).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will receive a single-session intervention consisting of two components, psychoeducation on compassion fatigue and self-dialogue, delivered using virtual reality equipment.
Interventions/Control_2
Participants in the control group will not receive the intervention and will undergo assessments only at the same time points as the intervention group, using the same outcome measures except for VR-specific measures.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A nurse
2) Currently engaged in cancer care, regardless of whether working in a specialized cancer ward or institution
3) Able to understand the study information in Japanese and respond to the questionnaire items
Key exclusion criteria
1) Currently receiving care at a specialized facility, such as a medical institution or psychological counseling service, due to mental health difficulties
2) Currently pregnant
3) A history of epileptic seizures
4) Severe visual impairment
5) A diagnosis of heart disease
6) Any other medical history or condition requiring special consideration with respect to VR experiences
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takaki |
| Middle name | |
| Last name | Fukumori |
Organization
Tokushima University
Division name
Graduate School of Technology, Industrial and Social Sciences
Zip code
770-8502
Address
1-1, Minamijosanjima-cho, Tokushima-city, Tokushima JAPAN
TEL
088-656-7194
t.fukumori@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaki |
| Middle name | |
| Last name | Fukumori |
Organization
Tokushima University
Division name
Graduate School of Technology, Industrial and Social Sciences
Zip code
770-8502
Address
1-1, Minamijosanjima-cho, Tokushima-city, Tokushima JAPAN
TEL
088-656-7194
Homepage URL
t.fukumori@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Barcelona
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Tokushima University, Graduate School of Technology, Industrial and Social Sciences, Division of Social Sciences
Address
1-1, Minamijosanjima-cho, Tokushima-city, Tokushima JAPAN
Tel
088-656-7104
sksoumks@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068683
