UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051950 |
|---|---|
| Receipt number | R000059226 |
| Scientific Title | Stress response during practical examination in medical training course students: The relationship with learning method and examination score |
| Date of disclosure of the study information | 2023/08/19 |
| Last modified on | 2023/08/19 16:25:15 |
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Basic information
Public title
Stress response during practical examination in medical training course students: The relationship with learning method and examination score
Acronym
Stress response during practical examination
Scientific Title
Stress response during practical examination in medical training course students: The relationship with learning method and examination score
Scientific Title:Acronym
Stress response during practical examination
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether practical examination causes stress for medical trainees and whether stress reactions are related to learning methods and practical examination scores.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
salivary amylase activity
Key secondary outcomes
State-Trait Anxiety Inventory, practical examination scores(attitudinal score, skill score)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
text-learning group
Interventions/Control_2
video-learning group
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
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants were third-year students in a four-year physiotherapy course and none had received any evaluation training for clinical practice, although they had knowledge about joint range-of-motion assessments.
Key exclusion criteria
participants who took a psychotropic drug or beta-blocker, with cardiovascular disease or mental disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Tanide |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Department of Frontier Health Sciences
Zip code
116-8551
Address
7-2-10, Higashi-Ogu, Arakawa City, Tokyo, Japan
TEL
03-3819-1211
atktnd.1117@gmail.com
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Tanide |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
The Tokyo Metropolitan Support Center for Preventative Long-term and Frail Elderly Care
Zip code
173-0004
Address
8th floor, Itabashi Center Bldg. 35-2 Itabashi,Itabashi-ku, Tokyo
TEL
03-5926-8236
Homepage URL
tanide@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan 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
Institutional Review Board Guidelines of the Tokyo Metropolitan University, Arakawa campus
Address
7-2-10, Higashi-Ogu, Arakawa City, Tokyo, Japan
Tel
03-3819-1211
a-rinri@jmj.tmu.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
専門学校東都リハビリテーション学院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
No information other than that contained on this website is publicly available.
Publication of results
Partially published
Result
URL related to results and publications
No information other than that contained on this website is publicly available.
Number of participants that the trial has enrolled
23
Results
1.Changes in stress responses
The Salivary Amylase Activity level gradually increased at just before, just after, and 15 minutes after.
2.Effects of prior learning methods
The attitudinal score on the practical examination of the text-learning group was significantly higher than that of the video-learning group (p=0.007).
3.Relationship between stress response and practical examination score
The attitudinal score was positively correlated with trait anxiety in each learning group.
Results date posted
| 2023 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were third-year students in a four-year physiotherapy course at Touto Rehabilitation College. All the participants were volunteers, and none had received any evaluation training for clinical practice, although they had knowledge about joint range-of-motion assessments.
Participant flow
First, the participants learned the practical examination content for minutes. Next, they answered the State-Trait Anxiety Inventory before the examination, and their Salivary Amylase Activity was measured at just before, just after, and 15 minutes after the examination. We measured the participants Salivary Amylase Activity once at the same time on another day without the examination and used it as a steady-state value.
The participants were randomly divided into text- and video-learning groups. The text learning group read a series of steps and methods for measuring the range of motion of the hip joint using paper materials, including text and photos. The video learning group watched video teaching material in which a measurer evaluated the hip joint range of motion according to the text material described above. The practical examination was conducted in a separate room to answer the State-Trait Anxiety Inventory, measure Salivary Amylase Activity, and assess prior learning.
Adverse events
None
Outcome measures
1.Stress response:Salivary Amylase Activity, State-Trait Anxiety Inventory questionnaire
2.Practical examination scores(skill score, attitudinal score, total score)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 23 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Some of the results were presented at the 29th Japan Academy of Health Sciences and the 35th Annual Meeting of the Japanese Association of Stress Sciences.
Management information
Registered date
| 2023 | Year | 08 | Month | 19 | Day |
Last modified on
| 2023 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059226
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