UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035311 |
|---|---|
| Receipt number | R000040211 |
| Scientific Title | Fear of Doctors in Infants: Fear Factors during Physical Examination |
| Date of disclosure of the study information | 2018/12/24 |
| Last modified on | 2024/04/06 11:42:57 |
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Basic information
Public title
Fear of Doctors in Infants: Fear Factors during Physical Examination
Acronym
Fear of Doctors in Infants
Scientific Title
Fear of Doctors in Infants: Fear Factors during Physical Examination
Scientific Title:Acronym
Fear of Doctors in Infants
Region
| Japan |
Condition
Condition
Healthy full-term infants
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A fear of doctors is common among infants and is important in terms of patient-centered care for infants, but the underlying factors are unknown.
Basic objectives2
Others
Basic objectives -Others
This study investigates the doctor-infant interaction by focusing on infant reactions. We examine the fear of doctors in infancy, reproducing the medical examination situation and observing the behaviors of infants who cried or did not cry.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The main outcome measures included the infants' facial expressions, gazes, and heart rate changes.
Key secondary outcomes
The data are analyzed during each scene of the physical examination.
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
| 6 | months-old | < |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy full-term infants
Key exclusion criteria
(1)Infants with neurological disorders, congenital abnormality, congenital heart or metabolic disorders.
(2) Infants having been previously seen by the investigators.
(3) Those who are considered to be ineligible by the investigators.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Motonobu |
| Middle name | |
| Last name | Watanabe |
Organization
Doshisha university
Division name
Center for baby science
Zip code
619-0225
Address
4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL
0774656040
m-watanabe@iseikai.jp
Public contact
Name of contact person
| 1st name | Motonobu |
| Middle name | |
| Last name | Watanabe |
Organization
Doshisha university
Division name
Center for baby science
Zip code
619-0225
Address
4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL
0774656040
Homepage URL
https://akachan.doshisha.ac.jp/
m-watanabe@iseikai.jp
Sponsor or person
Institute
Doshisha university, Center for baby science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha University Office of Ethics Review
Address
Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto-shi 602-8580
Tel
075-251-5138
ji-rinri@mail.doshisha.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
同志社大学 赤ちゃん学研究センター/Doshisha university, Center for baby science
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 24 | 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
61
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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 04 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 04 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 04 | Day |
Other
Other related information
During 2011-2016, the behaviors of 61 healthy infants (aged 176 to 617 days) toward an experimenter dressed in doctor's attire were observed in a simulated examination room.
Management information
Registered date
| 2018 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040211
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
