UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047014 |
|---|---|
| Receipt number | R000047286 |
| Scientific Title | The effect of warm compress on operative anxiety and ocular surface in patients undergoing ophthalmic surgery: a randomized controlled trial. |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/02/26 14:47:35 |
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Basic information
Public title
The effect of warm compress on operative anxiety and ocular surface in patients undergoing ophthalmic surgery.
Acronym
The effect of warm compress on anxiety and ocular surface.
Scientific Title
The effect of warm compress on operative anxiety and ocular surface in patients undergoing ophthalmic surgery: a randomized controlled trial.
Scientific Title:Acronym
The effect of warm compress on operative anxiety and ocular surface in patients undergoing ophthalmic surgery: a randomized controlled trial.
Region
| Japan |
Condition
Condition
Ophthalmic diseases that require surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The warm compress confirms the reduction of stress due to surgery and changes to the ocular surface. In addition, confirm that the bacterial detection rate does not increase by culturing the conjunctival sac with bacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
visual analog scale
State-Trait Anxiety Inventory
Key secondary outcomes
1.slit lamp examination
break up of tearfilm(BUT)
meibomian gland
2.bacterial culture fo conjunctival sac
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but 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
| Device,equipment |
Interventions/Control_1
warm compress 2 hr before surgery
Interventions/Control_2
with compress but not warm 2 hr before surgery
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
patients scheduled ophthalmic surgery for local anesthesia
Key exclusion criteria
patients scheduled ophthalmic surgery for general anesthesia
patients for emergency surgery
patients for re-operative surgery
patients for dementia
not obtained informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Ishikawa |
Organization
Saitama medical university
Division name
ophthalmology
Zip code
350-0495
Address
38 Morohongo, Moroyama, Saitama
TEL
042-995-1250
sho_ijp@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Ishikawa |
Organization
Saitama medical university
Division name
ophthalmology
Zip code
350-0495
Address
38 Morohongo, Moroyama, Saitama
TEL
042-995-1250
Homepage URL
sho_ijp@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
None
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
Saitama medical university
Address
Saitama medical university
Tel
0429951250
sho_ijp@saitama-med.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
| 2023 | Year | 01 | Month | 01 | 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
199
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | 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
| 2022 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047286
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| Registered date | File name |
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