UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032559
Receipt number R000037134
Scientific Title The influence of cervical hot fomentation to dry mouse feeling in the patients restricted oral intake
Date of disclosure of the study information 2018/06/01
Last modified on 2018/05/11 21:25:16

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Basic information

Public title

The influence of cervical hot fomentation to dry mouse feeling in the patients restricted oral intake

Acronym

The influence of cervical hot fomentation to dry mouse feeling in the patients restricted oral intake

Scientific Title

The influence of cervical hot fomentation to dry mouse feeling in the patients restricted oral intake

Scientific Title:Acronym

The influence of cervical hot fomentation to dry mouse feeling in the patients restricted oral intake

Region

Japan


Condition

Condition

The patients who admitted in our ER department.

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to investigate the pesponse to the dyr mouse feeling by cervical hot fomentation through the sialagogic effect in the patients who are restricted oral intake.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary outcome is to evaluate the dyr mouse feeling by VAS scale.

Key secondary outcomes

Secondary outcomes are the salivary amylase level and the oral moisture level before and after the treatment.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A warmed hot pack of 40 to 50 degree centigrade is applied to the neck for ten minutes.

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

Admitted in our ER department.
Who have a dry mouse feeling.
Who approved the regulated instruction and the consent forms.

Key exclusion criteria

Who are prohibited the protocol by doctor.
Who are unable to contact for the intubated management.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sakanoi Astuko

Organization

Yamaguchi University Hospital

Division name

Division of Nursing

Zip code


Address

1-1-1,MInamiKogushi,Ube Ctiy,Yamaguchi Prefecfnre, Japan

TEL

0836-22-2773

Email

sakanoi@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sakanoi Astuko

Organization

Yamaguchi University Hospital

Division name

Division of Nursing

Zip code


Address

1-1-1,MInamiKogushi,Ube Ctiy,Yamaguchi Prefecfnre, Japan

TEL

0836-22-2773

Homepage URL


Email

sakanoi@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi University

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

2018 Year 06 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

2018 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2018 Year 06 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



Management information

Registered date

2018 Year 05 Month 11 Day

Last modified on

2018 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name