UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055152 |
|---|---|
| Receipt number | R000063007 |
| Scientific Title | Effect of Educational Training and Direct Observation on Hand Hygiene in a Dental College Hospital |
| Date of disclosure of the study information | 2024/08/03 |
| Last modified on | 2024/08/23 12:10:18 |
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Basic information
Public title
Effect of Educational Training and Direct Observation on Hand Hygiene in a Dental College Hospital
Acronym
Hand Hygiene in a Dental College Hospital
Scientific Title
Effect of Educational Training and Direct Observation on Hand Hygiene in a Dental College Hospital
Scientific Title:Acronym
Hand Hygiene in a Dental College Hospital
Region
| Japan |
Condition
Condition
Healthcare Professionals Working in the Outpatient Dental Clinic of a Dental College Hospital
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the importance of hand hygiene in preventing healthcare-associated infections and to verify the effectiveness of the direct observation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hand Hygiene Compliance Rates Before and After In-Hospital Infection Control Training Sessions
Key secondary outcomes
Annual Trends in the Consumption of Alcohol-Based Hand Sanitizer
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Eight Direct Observations of Hand Hygiene Conducted Between April 2022 and March 2024
2. Consumption of Alcohol-Based Hand Sanitizer from January 2019 to December 2023
Key exclusion criteria
Nothing
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-0003
Address
82 Inaoka Yokosuka Kanagawa, Japan
TEL
046-822-8751
kuroda@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-0003
Address
82 Inaoka Yokosuka Kanagawa, Japan
TEL
046-822-8751
Homepage URL
kuroda@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Kanagawa Dental University
Address
82 Inaoka Yokosuka Kanagawa, Japan
Tel
046-822-8751
kenkyo@kdu.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
| 2024 | Year | 08 | Month | 03 | 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
Initial blind observation showed a 15.6% overall compliance rate, highest (25%) after touching patient surroundings. After education and explicit observation, compliance significantly increased to 36% overall, with notable improvements in specific categories.
Results date posted
| 2024 | Year | 08 | Month | 23 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 04 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 04 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 05 | Day |
Other
Other related information
This study is a retrospective observational research. It introduces a direct observation method based on WHO's 'Five Moments for Hand Hygiene' and evaluates its effect on behavior change. The primary outcome measure is the hand hygiene compliance rate before and after in-hospital infection control training sessions, analyzed by profession (dentists, dental hygienists, dental assistants, and dental residents). The secondary outcome measure is the annual trend in alcohol-based hand sanitizer consumption. This study aims to elucidate the accuracy of the direct observation method, the Hawthorne effect, and its impact on healthcare workers' behavior.
Management information
Registered date
| 2024 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063007
