UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023272 |
|---|---|
| Receipt number | R000026810 |
| Scientific Title | Palliative care on face-down posture-related pain after vitrectomy: a randomized control trial. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/11/07 17:51:19 |
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Basic information
Public title
Palliative care on face-down posture-related pain after vitrectomy: a randomized control trial.
Acronym
Palliative care on face-down posture-related pain after vitrectomy: a randomized control trial.
Scientific Title
Palliative care on face-down posture-related pain after vitrectomy: a randomized control trial.
Scientific Title:Acronym
Palliative care on face-down posture-related pain after vitrectomy: a randomized control trial.
Region
| Japan |
Condition
Condition
Patients required keeping a strict face-down positioning to treat rhgmatogenous retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the utility of the stretch method in patients with face-down positioning after vitrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The face-down posture-related pain (Visual analog scale) during postoperative 2 weeks
Key secondary outcomes
Short-Form 8; SF-8
Geriatric Depression Scale; GDS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The stretch method group (during postoperative 2 weeks, 15min/set, 2set/day)
Interventions/Control_2
The control group (traditional care; the fomentation or thermotherapy at patient's desire)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants required keeping a strict face-down positioning to treat rhgmatogenous retinal detachment
Ability to give informed consent
Key exclusion criteria
Spinal or lumbar disorder
Hump back
History of previous spinal or lumbar operation
Allergy to fomentation
Mental disorder
Blindness in non-study eye
Under 19 years old
Inability to give informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sota Haruna |
Organization
Shiga University of Medical Science Hospital
Division name
nursing department
Zip code
Address
Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL
0775483543
haruna12@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sota Haruna |
Organization
Shiga University of Medical Science Hospital
Division name
nursing department
Zip code
Address
Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL
0775483543
Homepage URL
haruna12@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science Hospital, nursing department
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.nurse.or.jp/up_pdf/20180905134941_76.pdf
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 21 | Day |
Last modified on
| 2018 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026810
