UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055108 |
|---|---|
| Receipt number | R000062953 |
| Scientific Title | A survey on reducing the burden on doctors and patient evaluations by changing the method of preoperative explanation |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2024/07/29 19:46:12 |
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Basic information
Public title
A survey on reducing the burden on doctors and patient evaluations by changing the method of preoperative explanation
Acronym
A survey on reducing the burden on doctors and patient evaluations by changing the method of preoperative explanation
Scientific Title
A survey on reducing the burden on doctors and patient evaluations by changing the method of preoperative explanation
Scientific Title:Acronym
A survey on reducing the burden on doctors and patient evaluations by changing the method of preoperative explanation
Region
| Japan |
Condition
Condition
Diseases requiring surgery, including cataracts
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of video-based surgical explanations and other measures on consultation time, patient satisfaction and changes in understanding among patients about to undergo cataract surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire items assess the patient's satisfaction with the explanation, satisfaction with the waiting time, comprehension of the operation and ease of viewing the video. Qualitative evaluations are quantified and examined for significance using statistical methods such as t-tests and x-square tests, with a p-value < 0.05 being considered significant.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
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
Patients diagnosed with cataract by a physician and scheduled for inpatient or outpatient surgery for lens reconstruction in one or both eyes. It is envisaged that there will be between 20 and 150 cases in the control and comparison groups respectively. In the control group, the doctor will provide a face-to-face, oral surgical explanation using written instructions. The comparison group will be allocated to different groups for different periods of time to ensure an equal number of cases in each group, changing the method of explanation every two months or so. A questionnaire will be used in the study. The questionnaire will consist of a Questionnaire for those receiving pre-operative explanation of cataract surgery and a Quiz about cataract surgery, and will include items on understanding of the surgical explanation, satisfaction, waiting time for consultation, other questions and a comprehension check. Each takes about five minutes to answer. The questionnaire is administered only once, on the day of the outpatient consultation, after the surgery schedule has been decided.
Interventions/Control_2
The comparison group will be allocated to different groups for different periods of time to ensure an equal number of cases in each group, changing the method of explanation every two months or so. A questionnaire will be used in the study. The questionnaire will consist of a Questionnaire for those receiving pre-operative explanation of cataract surgery and a Quiz about cataract surgery, and will include items on understanding of the surgical explanation, satisfaction, waiting time for consultation, other questions and a comprehension check. Each takes about five minutes to answer. The questionnaire is administered only once, on the day of the outpatient consultation, after the surgery schedule has been decided.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study subjects will be patients and their family members who visit the Department of Ophthalmology, University of Tokushima Hospital, at the research institution, are diagnosed with cataracts and are scheduled to undergo cataract surgery. There will be no age or gender restrictions.
Key exclusion criteria
If the doctor decides that the patient or a family member or other person is unable to answer the answer sheet correctly due to cognitive decline or other reasons.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Shinomiya |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Ophthalmology
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
088-633-7163
gannka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kajita |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Ophthalmology
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
088-633-7163
Homepage URL
gannka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
clinical research center for developmental therapeutics
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
Tel
088-633-9294
awachiken@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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 31 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062953
