UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054536 |
|---|---|
| Receipt number | R000062303 |
| Scientific Title | Investigation of the Efficacy of Pain Relief Using Sucrose and Pacifier in Fundus Examination |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2024/06/19 16:59:53 |
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Basic information
Public title
Investigation of the Efficacy of Pain Relief Using Sucrose and Pacifier in Fundus Examination
Acronym
Investigation of the Efficacy of Pain Relief Using Sucrose and Pacifier in Fundus Examination
Scientific Title
Investigation of the Efficacy of Pain Relief Using Sucrose and Pacifier in Fundus Examination
Scientific Title:Acronym
Investigation of the Efficacy of Pain Relief Using Sucrose and Pacifier in Fundus Examination
Region
| Japan |
Condition
Condition
Retinopathy of prematurity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of sucrose/pacifier pain relief in fundus examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of PIPP (Premature Infant Pain Profile) is used to evaluate the pain score from the patient's behavioral status and vital signs from 15 seconds before fundus examination to 30 seconds after right eye examination.
Key secondary outcomes
A sound level meter is used to evaluate the patient's crying during the examination. The sound level meter measures a 1-second average and determines that crying is present when it exceeds 80 dB.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Other |
Interventions/Control_1
Two minutes prior to fundus examination, 0.15 cc of "P-Less care sucrose 24% solution," a standardized food for infants, is administered.
Interventions/Control_2
Two minutes prior to fundus examination, the patient is given a non-nutritive sucking with a pacifier.
Interventions/Control_3
Control without intervention.
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
| 30 | weeks-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A modified gestational age of 30 weeks or later, with fundus examination routinely performed.
Key exclusion criteria
Who require airway management or are using insulin preparations.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KAYO |
| Middle name | |
| Last name | SHINOMIYA |
Organization
Tokushima University
Division name
Department of Ophthalmology, Institute of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto Tokushima
TEL
0886337163
shinomi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | KAYO |
| Middle name | |
| Last name | SHINOMIYA |
Organization
Tokushima University
Division name
Department of Ophthalmology, Institute of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto Tokushima
TEL
0886337163
Homepage URL
shinomi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokushima University
Address
3-18-15 Kuramoto Tokushima
Tel
0886337163
shinomi@tokushima-u.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 | 06 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062303
