UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024658
Receipt number R000028366
Scientific Title Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/31 20:20:39

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension

Acronym

Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension

Scientific Title

Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension

Scientific Title:Acronym

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

1st name
Middle name
Last name Chie Myouchin

Organization

hospital

Division name

West 9 floor

Zip code


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

1st name
Middle name
Last name Chie Myouchin

Organization

Tohoku University

Division name

West 9 Floor

Zip code


Address

1-1 Seryoutyou Aoba-ku Sedai-shi Miyagi-ken 8574-980

TEL

022-7171-7786

Homepage URL


Email

dbfhw551@yahoo.co.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

Preinitiation

Date of protocol fixation

2016 Year 10 Month 31 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028366