UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Title of the study (Brief title)	Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Region	Japan

Condition
Condition	pulmonary arterial hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify the problems of nursing care in pain management to the Cardiology definitive Treprostinil continuous subcutaneous administration patient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who had done Treprostinil continuous subcutaneous administration from October 2015 until June 2016.
Key exclusion criteria	Not set for the case study.
Target sample size	2

Research contact person
Name of lead principal investigator	Chie Myouchin
Organization	hospital
Division name	West 9 floor
Address	1-1 Seryoutyou Aoba-ku Sedai-shi Miyagi-ken 8574-980
TEL	022-717-7786
Email	dbfhw551@yahoo.co.jp

Public contact
Name of contact person	Chie Myouchin
Organization	Tohoku University
Division name	West 9 Floor
Address	1-1 Seryoutyou Aoba-ku Sedai-shi Miyagi-ken 8574-980
TEL	022-7171-7786
Homepage URL
Email	dbfhw551@yahoo.co.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 11 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 10 Month 31 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In the west 9 floor ward researchers belong, to target the two patients who started the Trepurostinil continuous subcutaneous administration to pulmonary hypertension. Symptoms from the October 2015 first case of the subject was admitted to the second example in June 2016 by the subject was discharged of, about the contents of the implementation nursing intervention, information collected from nursing records and medical records. Lack of information to supplement with your recorder. Further, based on the data obtained from nursing records and medical records, summarized in chronological nursing interventions

Management information
Registered date	2016 Year 10 Month 31 Day
Last modified on	2016 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028366