UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054766 |
|---|---|
| Receipt number | R000062584 |
| Scientific Title | Effects on Physical and Psychological Condition of Nursing Students during Clinical Practice: A Pre-and Post-Comparative Study of Lavender-Scented Hand Cream. |
| Date of disclosure of the study information | 2024/07/15 |
| Last modified on | 2024/12/25 11:27:06 |
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Basic information
Public title
Effects on Physical and Psychological Condition of Nursing Students during Clinical Practice: A Pre-and Post-Comparative Study of Lavender-Scented Hand Cream.
Acronym
Effects on Physical and Psychological Condition of Nursing Students during Clinical Practice: A Pre-and Post-Comparative Study of Lavender-Scented Hand Cream.
Scientific Title
Effects on Physical and Psychological Condition of Nursing Students during Clinical Practice: A Pre-and Post-Comparative Study of Lavender-Scented Hand Cream.
Scientific Title:Acronym
Effects on Physical and Psychological Condition of Nursing Students during Clinical Practice: A Pre-and Post-Comparative Study of Lavender-Scented Hand Cream.
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether lavender-scented hand cream is useful to reduce stress of nursing students in high-stress field practice due to anxiety and tension before practice and fatigue and tension during practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States (POMS) Abbreviated Version
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Please use hand cream before going to bed during the first week of the internship (except Fridays).
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A student from the Faculty of Health and Nursing, Wakayama Medical University, about to begin clinical training.
Key exclusion criteria
Those who have incomplete answers to the questionnaire, those who find the scent of lavender bothersome, and those who are sensitive to the irritation of hand cream.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | hiroko |
| Middle name | |
| Last name | hayakawa |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
6410011
Address
580 MIKAZURA WAKAYAMA JAPAN
TEL
073-446-6700
hayakawa@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | hiroko |
| Middle name | |
| Last name | hayakawa |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
6410011
Address
580 MIKAZURA WAKAYAMA JAPAN
TEL
073-446-6700
Homepage URL
hayakawa@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
School of Health and Nursing Science,Wakayama Medical 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
School of Health and Nursing Science,Wakayama Medical University
Address
580 MIKAZURA WAKAYAMA JAPAN
Tel
073-446-6700
hayakawa@wakayama-med.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 | 07 | 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
21
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We are currently preparing a report and will post the results once it is complete.
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 | 07 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062584
