UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063567 |
|---|---|
| Receipt number | R000072742 |
| Scientific Title | Psychological Burden and the Influence of the Vaccination Environment in Group Vaccination among Healthcare Staff |
| Date of disclosure of the study information | 2026/11/09 |
| Last modified on | 2026/11/09 14:51:14 |
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Basic information
Public title
A Study of Psychological Burden and the Vaccination Environment among Hospital Staff
Acronym
A Study of Psychological Burden during Vaccination and the Vaccination Venue Environment
Scientific Title
Psychological Burden and the Influence of the Vaccination Environment in Group Vaccination among Healthcare Staff
Scientific Title:Acronym
Psychological Burden and the Influence of the Vaccination Environment
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of music in the vaccination venue on recipients pain during vaccination.
Basic objectives2
Others
Basic objectives -Others
To exploratorily evaluate stress, anxiety, perceived burden, impressions of the vaccination venue, associated factors, and stress, perceived burden, and fatigue among operational staff.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate pain during vaccination among vaccine recipients using a Numerical Rating Scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Background music
Interventions/Control_2
No-music
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
Staff of the Center or the Organization who receive a vaccination on the designated study date.
Key exclusion criteria
Individuals who have provided informed consent but are unable to attend on the scheduled vaccination date.
Individuals who already experience pain in the upper arm.
Individuals with hearing impairments that prevent them from listening to music.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Osaki |
Organization
Osaka Prefectural Hospital Organization
Division name
Infectious Disease Center
Zip code
541-8567
Address
3-1-69 Otemae, chuo-ku, Osaka541-8567 Japan
TEL
0669451900
masahide.osaki@oici.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Osaki |
Organization
Osaka Prefectural Hospital Organization
Division name
Infectious Disease Center
Zip code
541-8567
Address
3-1-69 Otemae, chuo-ku, Osaka541-8567 Japan
TEL
0669451900
Homepage URL
masahide.osaki@oici.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Prefectural Hospital Organization Osaka International Cancer Institute Certified Review Board
Address
3-1-69Otemae,Chuo-Ku,Osaka
Tel
06-6945-1181
rinri01@opho.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
| 2026 | Year | 11 | Month | 09 | 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
| 2026 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 09 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072742
