UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045866 |
|---|---|
| Receipt number | R000052357 |
| Scientific Title | Palliative care in COVID-19 pandemic for spiritual pain |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2022/12/13 10:48:56 |
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Basic information
Public title
Hospital visit restrictions might be increases the doses of Morphine in Terminal care.
Acronym
Palliative care in COVID-19 pandemic for spiritual pain
Scientific Title
Palliative care in COVID-19 pandemic for spiritual pain
Scientific Title:Acronym
COVID-19 pandemic for spiritual pain
Region
| Japan |
Condition
Condition
pain control in terminal care
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Clinical immunology |
| Psychosomatic Internal Medicine | Infectious disease | Geriatrics |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Anesthesiology |
| Oral surgery | Neurosurgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compared the total doses of morphine in each patient in terminal stage before death, between before the COVID-19 pandemic and during COVID-19 pandemic(prohibited people visiting) objectively.(with or without prohibited people visiting)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total dose of morphine
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who hospitalized in NHO Tokyo Medical Center
2) Patients who received terminal care before death with morphine
3) Patients who died in NHO Tokyo medical Center
Key exclusion criteria
Patients who did not die in NHO Tokyo Medical Center
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | Tsunoda |
| Last name | Tsunoda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Clinical Research Center
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguro-ku, Tokyo, Japan.
TEL
0334110111
koichi.tsunoda@kankakuki.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | Tsunoda |
| Last name | Tsunoda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Artificaila Organs and Medical Creations
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguro-ku, Tokyo, Japan
TEL
0334110111
Homepage URL
koichi.tsunoda@kankakuki.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical
Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka Meguro-ku
Tel
+81334110111
koichi.tsunoda@kankakuki.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
| 2021 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
300
Results
Kudo H, Miyata C, Kawaguchi Y, Yachi Y, Shinfuku M, Kinoshita T, Kurihara T, Momiyama Y, Chong T, Kobayashi Y, Takazawa M, Itoh K, Tsunoda K. Do Hospital Visit Restrictions Cause Increase in the Doses of Morphine in Terminal Care? Spiritual Pain and Palliative Care in the COVID-19 Pandemic. Am J Med. 2022 Oct;135(10):1156-1157. doi: 10.1016/j.amjmed.2022.04.011.
Results date posted
| 2022 | Year | 12 | Month | 13 | Day |
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
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052357
