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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033305
Receipt No. R000037965
Official scientific title of the study Satisfaction survey of eyedrop guidance using check list
Date of disclosure of the study information 2018/07/11
Last modified on 2018/07/06

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Basic information
Official scientific title of the study Satisfaction survey of eyedrop guidance using check list
Title of the study (Brief title) Satisfaction survey of eyedrop guidance using check list
Region
Japan

Condition
Condition Ophthalmic surgery target patient
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Most of patients hospitalized in our House south ward ninth floor ophthalmology are operation purposes, and the mean hospitalization is around five days. Instillation becomes the start after art after an operation from the first day, and the instillation instruction to a patient is carried out by a nurse, but there are many patient that I am seen after an operation, and becomes bad, and the instillation maneuver acquisition is difficult and patients whom it is old, and instillation contents and time cannot understand. Patients expected that it is difficult to perform instillation by self-administration after a discharge are seen a lot.
There was not the criterion that a patient was able to learn an instillation maneuver so far in our ward, and it was determined by each nurse, and it was thought that a difference produced it in an instillation acquisition degree of the patient. Ubukata "was able to grasp the situation of the instillation maneuver of the each operation patient by evaluating a self-instillation maneuver assessment sheet". I speak it with 1). I thought that I might be connected for the improvement of the instillation maneuver acquisition degree of the patient in making the standard that I unified about instillation instruction and making a check list item by item and made a check list in reference to existing check list 2) 3) 4) newly at instillation instruction.
In this study, it is intended that I confirm the satisfaction of the patient about the instillation instruction using the check list which I made and thinks that there is significance that a suggestion doing is got by the check list which is tied to more substantial instruction while I will continue it in future and use it.
Basic objectives2 Others
Basic objectives -Others Satisfaction survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Interviews and interview surveys will be conducted at discharge discharge guidance 2 to 5 days after instructing instillation. The obtained data is simply calculated and summarized. Depending on the item, labeling・categorizing and analyzing qualitatively.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 The intervention period is one week. After the first day after the surgery, the reassign band (10:00, 13:00, 16:00), using a checklist of the contents to confirm whether the patient is understandable about the clean surface of the pre-eye drops and the time and the number of times, nurses to implement the eye drops. Interview interviews are conducted during discharge guidance.
Interventions/Control_2
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The intervention group was hospitalized for surgical purposes at the 9th floor of the South nine-storey Hospital of the Gunma University School of Medicine, and the patient who received the post-operative eye-care guidance should be 75 years of age or older who had obtained approval for the research.
Key exclusion criteria The exclusion criterion may be deemed to be an obvious mental or cognitive impairment if there is no ability to make a decision on your own.
Target sample size 20

Research contact person
Name of lead principal investigator Oginuma akemi
Organization Gunma university hospital
Division name South 9th Floor Ward
Address No. 39, Showa-machi, Maebashi-cho, Gunma
TEL 027-220-8341
Email aoginuma@gunma-u.ac.jp

Public contact
Name of contact person Emura Aiko
Organization Nursing Department
Division name South 9th Floor Ward
Address No. 39, Showa-machi, Maebashi-cho, Gunma
TEL 027-220-8341
Homepage URL
Email mai1113@gunma-u.ac.jp

Sponsor
Institute Gunma university hospital
Institute
Department

Funding Source
Organization None.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 11 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2019 Year 07 Month 02 Day
Anticipated trial start date
2019 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information [List of cited references]
1) Mieko Mika, Tomoko Haga. Journal of agricultural medicine, Vol. 64, No. 1, 2015, P 61 - 65
2) Keio University Hospital: Ophthalmic Care, Vol. 10, No. 8, 2008, P 776 - 779
3) Ehime University School of Medicine Affiliated Hospital: Ophthalmic Care, Vol. 10, No. 8, 2008, P 780 - 781
4) Yamaguchi Haruki, Miura Takeshi. Efforts toward unification of eye drop technique evaluation method in ophthalmologic clinical path: Journal of the Japan Hospital Pharmacists Association, Vol. 48, No. 11, 2012, P 1366-1370

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037965

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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