UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040519 |
|---|---|
| Receipt number | R000046254 |
| Scientific Title | Analysis of intraoperative pain and fear related data with preoperative explanation using surgical microscope light source video |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2020/05/26 11:34:31 |
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Basic information
Public title
Analysis of intraoperative pain and fear related data with preoperative explanation using surgical microscope light source video
Acronym
Analysis of intraoperative pain and fear related data with preoperative explanation using surgical microscope light source video
Scientific Title
Analysis of intraoperative pain and fear related data with preoperative explanation using surgical microscope light source video
Scientific Title:Acronym
Analysis of intraoperative pain and fear related data with preoperative explanation using surgical microscope light source video
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect obtained by explaining preoperatively the image of the viewpoint of the patient during surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity,eye position analysis,questionnaire about mini cog, pain, anxiety and memory
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Nursing explanation
Interventions/Control_2
No nursing explanation
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cataract
Key exclusion criteria
Eye disease except cataract
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | Noguchi |
| Last name | Aimi |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
6711227
Address
68-1, waku, aboshi
TEL
0792728555
n_santa_pl0_0lq@hotmail.com
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Aimi |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
671-1227
Address
68-1, waku, aboshi
TEL
0792728555
Homepage URL
n_santa_pl0_0lq@hotmail.com
Sponsor or person
Institute
Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsukazaki Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukazaki Hospital
Address
68-1, waku, aboshi
Tel
0792728555
n.santar0721@gmail.com
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
| 2022 | Year | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046254
