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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035311
Receipt No. 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 2018/12/19

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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
Middle name
Last name Yukuo Konishi
Organization Doshisha university
Division name Center for baby science
Zip code
Address 4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL 0774-73-1917
Email ykonishi@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motonobu Watanabe
Organization Doshisha university
Division name Center for baby science
Zip code
Address 4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL 0774-73-1917
Homepage URL
Email mt691217@gmail.com

Sponsor
Institute Doshisha university, Center for baby science
Institute
Department

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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2011 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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