UMIN-CTR Clinical Trial

Public title

Satisfaction survey of eyedrop guidance using check list

Acronym

Satisfaction survey of eyedrop guidance using check list

Scientific Title

Satisfaction survey of eyedrop guidance using check list

Scientific Title:Acronym

Satisfaction survey of eyedrop guidance using check list

Region

Japan

Condition

Ophthalmic surgery target patient

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Oginuma akemi

Organization

Gunma university hospital

Division name

South 9th Floor Ward

Zip code

Address

No. 39, Showa-machi, Maebashi-cho, Gunma

TEL

027-220-8341

Email

aoginuma@gunma-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Emura Aiko

Organization

Nursing Department

Division name

South 9th Floor Ward

Zip code

Address

No. 39, Showa-machi, Maebashi-cho, Gunma

TEL

027-220-8341

Homepage URL

Email

mai1113@gunma-u.ac.jp

Institute

Gunma university hospital

Institute

Department

Personal name

Organization

None.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

群馬大学医学部附属病院

Date of disclosure of the study information

2018

Year

07

Month

11

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

We conducted a satisfaction survey for 22 people who got consent. "Yes" 22 people, "No" 0 person to the item that the instillation was easy to understand. "Yes" 0 person, "No" 22 persons to the item as to whether the content of instillation was different by the nurse. "Yes" 22 people, "No" 0 persons to the item of whether or not the eye drop was understood. 12 points for "Yes" and "No" for 10 items for which it was difficult to instill eye drops. As a breakdown of "Yes" in the above item, eyedrops are instilled such that the tip of the eye drops does not stick to the eyeball or the eyelids: 11 people, eye drops attached to the eyelids etc. and instantly enter the eyeballs: 4 Name, number of eyedrops Time: 1 person, leave at the interval of more than 5 minutes at the following points: 1 item, explanation of the explanation of the criteria for the item of good points to be instructed or points to be improved It was easy to understand how to use eyedroppers easier to understand, it was okay to tell us the efficacy of eye drops, it was okay for me to understand that the color of the eye of the eye drop table and the color of the eyedrop's lid corresponded However, as the talk was a bit hurried, I got the opinion that it would be better to explain carefully over time.

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

Recruitment status

Completed

Date of protocol fixation

2019

Year

07

Month

02

Day

Date of IRB

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

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

Registered date

2018

Year

07

Month

06

Day

Last modified on

2019

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037965