UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015383
Receipt number R000017903
Scientific Title How verbal exchange before intravenous cannulation effects pain: a randomized controlled trial in the dental clinic.
Date of disclosure of the study information 2014/10/09
Last modified on 2015/01/05 22:33:54

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Basic information

Public title

How verbal exchange before intravenous cannulation effects pain: a randomized controlled trial in the dental clinic.

Acronym

How verbal exchange before intravenous cannulation effects pain: a randomized controlled trial in the dental clinic.

Scientific Title

How verbal exchange before intravenous cannulation effects pain: a randomized controlled trial in the dental clinic.

Scientific Title:Acronym

How verbal exchange before intravenous cannulation effects pain: a randomized controlled trial in the dental clinic.

Region

Japan


Condition

Condition

Tooth Disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The patient's pain is due to being warned about the discomfort before painful procedures. To not warn patients may lead to significant decrease in it. The purpose of this study is to find out if not warning patients of pain before i.v. cannulation reduce their pain before dental treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

verbal numerical rating score(VNRS)
visual analogue scale(VAS)

Key secondary outcomes

(1)Whether or not there is unprompted vocalization of pain or discomfort, during i.v. cannulation.
(2) Whether or not there is spontaneous patient arm withdrawal during i.v. cannulation.
(3) Whether or not there is Medical emergency.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

The intervention involves communicating information prior to i.v. cannula insertion without using words with painful content.

Interventions/Control_2

The intervention involves communicating information prior to i.v. cannula insertion with painful content.

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

The patients awaiting i.v. cannulation before dental treatments in our department/ASA Physical Status 1 or 2/Provided written informed consent to undergo the procedure.

Key exclusion criteria

Patients who treated with analgesic medication within 24 hours/Patients who unable to communicate in Japanese/Patients with belonephobia/Patients who have hypersensitivity to a disinfectant/Patients who have a known history of difficult venous access or poor peripheral vein/Patients who are judged to be inappropriate for this study by dentists

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeo Nakayama

Organization

University of Kyoto,School of Public Health

Division name

Department of Health Informatics

Zip code


Address

Yoshida konoe-cho,sakyo-ku,kyoto,606-8501,JAPAN

TEL

075-753-9479

Email

nakayama.takeo.4a@kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Luka Kishida

Organization

University of Kyoto,School of Public Health

Division name

Department of Health Informatics

Zip code


Address

Yoshida konoe-cho,sakyo-ku,kyoto,606-8501,JAPAN

TEL

075-753-9479

Homepage URL


Email

luka-kishida@umin.ac.jp


Sponsor or person

Institute

University of Kyoto,School of Public Health

Institute

Department

Personal name



Funding Source

Organization

University of Kyoto,School of Public Health

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Osaka dental university hospital

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

大阪歯科大学附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 09 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

No longer recruiting

Date of protocol fixation

2014 Year 10 Month 02 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 10 Day

Last follow-up date

2014 Year 10 Month 31 Day

Date of closure to data entry

2014 Year 11 Month 22 Day

Date trial data considered complete

2014 Year 11 Month 30 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 09 Day

Last modified on

2015 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017903


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name