UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046783 |
|---|---|
| Receipt number | R000053347 |
| Scientific Title | The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2022/01/31 11:16:59 |
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Basic information
Public title
The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Acronym
The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Scientific Title
The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Scientific Title:Acronym
The usefulness of informed consent with video in the preoperative patient for inguinal Hernia: A Pilot Study
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the effectiveness of supplemental explanatory videos in preoperative informed consent
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction and understanding
Questionnaire survey after preoperative informed consent
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Watch an explanatory video before operation
Interventions/Control_2
No video
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inguinal hernia preoperative
First surgery
Understandable
Key exclusion criteria
Emergency surgery
Visual / hearing impairment
Perform other surgery at the same time
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakashima |
Organization
Kyoto University
Division name
Pharmacoepidemiology
Zip code
6068501
Address
Yoshidakonoecyo Sakyoku Kyoto
TEL
075-753-9469
nakashima.masayuki.4p@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakashima |
Organization
Kyoto University
Division name
Pharmacoepidemiology
Zip code
6068501
Address
Yoshidakonoecyo Sakyoku Kyoto
TEL
075-753-9469
Homepage URL
nakashima.masayuki.4p@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Pharmacoepidemiology
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Pharmacoepidemiology
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
Kyoto University
Address
Yoshidakonoecyo Sakyoku Kyoto
Tel
075-753-9469
nakashima.masayuki.4p@kyoto-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
| 2022 | Year | 01 | 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
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 31 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053347
