UMIN-CTR Clinical Trial

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
Email	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
Email	n_santa_pl0_0lq@hotmail.com

Sponsor
Institute	Tsukazaki Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046254