UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	koichi.tsunoda@kankakuki.jp

Sponsor
Institute	National Hospital Organization Tokyo Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052357