UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045488 |
|---|---|
| Receipt number | R000051931 |
| Scientific Title | Empirical study on the effect of improving the sonic environment in the operating room on the health and cognitive behavior of medical staff: with special reference to hypersonic effect |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/10/31 11:43:26 |
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Basic information
Public title
Empirical study on the effect of improving the sonic environment in the operating room on the health and cognitive behavior of medical staff: with special reference to hypersonic effect
Acronym
HYS
Scientific Title
Empirical study on the effect of improving the sonic environment in the operating room on the health and cognitive behavior of medical staff: with special reference to hypersonic effect
Scientific Title:Acronym
HYS
Region
| Japan |
Condition
Condition
Environmental stress
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the usefulness of improving the sound environment for medical staff (natural sound environment: hypersonic group) in the operating room (liver resection / pancreatic resection surgery) in reducing psychological and physical stress of medical staff and in health management.
Cases are divided into two groups by randomized blinding between the artificial sound environment (non-hypersonic) group and the normal operating room sound environment group.
The primary endopoint is the stress reduction effect of the medical staff by hypersonic sound.
Basic objectives2
Others
Basic objectives -Others
The secondary endopints are the analysis of the operating room sound environment (noise), and the influence on the medical staff due to the difference in the sound environment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The effectiveness of stress reduction upon medical staff in the operating theatre by Hypersonic Sound
Items of investigation:
#1 stress, performance evaluation: CES-D (National Institute of Mental Health), JPSS (Japanese version of subjective stress evaluation).
#2 Cognitive function: Benton Visual Retention test. #3 Physiological function: heart rate, respiratory rate, salivary alfa-amylase, salivary cortisol activity
Key secondary outcomes
1# FFT (Fast Fourier Transform) analysis of the environmental noises in the operating theatre, 2# influences on medical staff stress due to differences in sonic environment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
HYP Group: Hypersonic Natural Sound Environment Group
Interventions/Control_2
N-HYP Group: Non-Hypersonic Natural Sound Environment Group
Interventions/Control_3
Normal Sound Environment Group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
120 medical professionals (surgeons and the first assistant surgeons) involved in 60 elective cases of major liver or pancreas surgery in Mie University Hospital
Key exclusion criteria
#1 Emergency surgery, #2 Overtime Surgery, #3 surgery with extraordinary invasiveness, #4 if surgoens were involved in the previous study within two weeks, #5 cases considered inapropriate by the principal investigator in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sakurai |
Organization
Iga City General Hospital
Division name
General Surgery / Hepatobiliarypancreatic Surgery
Zip code
518-0823
Address
831 Shijukucho, Iga, Mie, 515-0823,Japan.
TEL
0595-24-1111
hirodon@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Oku |
Organization
Iga City Ueno General Hospital
Division name
General affairs office of Iga City General Hospital
Zip code
515-0823
Address
831 Shijukucho, Iga, Mie, 515-0823,Japan.
TEL
0595-24-1111
Homepage URL
byouin-soumu@city.iga.lg.jp
Sponsor or person
Institute
General Surgery / Hepatobiliarypancreatic Surgery, Iga City Ueno General Hospital
Institute
Department
Personal name
Hiroyuki Sakurai
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of information medicine, National center of Neurology and Psychiatry, Japan.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee of Iga City Ueno General Hospital
Address
831 Shijukucho, Iga, Mie, 515-0823,Japan.
Tel
0595-24-1111
byouin-soumu@city.iga.lg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
ICGH#708-2
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
伊賀市立上野総合市民病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | 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
30
Results
Ethics committee approved / case enrollment in progress
Results date posted
| 2023 | Year | 10 | Month | 31 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to delays in equipment procurement and start of case registration due to the COVID-19 outbreak.
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051931
