Protocol summary

Summary
This study is a clinical trial to examine the impact of the patient's condition during IV catheterizing on pain and anxiety of patients was designed, 60 patients from the surgical wards and emergency hospitals will be selected and will be randomly divided into 2 groups that’s In one group supine position, and the other group sitting position will be taking IV catheterizing, Before and after the IV catheterizing anxiety and, pain in both groups after the IV catheterizing will be research.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050521896N3
Registration date: 2015-05-31, 1394/03/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-31, 1394/03/10
Registrant information
Name
Mokhtar Mahmoudi
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 4435 5764
Email address
mokhtar.mahmoudi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sleeping and sitting positions during IV catheterizing on pain and anxiety caused
Public title
The effect of sleeping and sitting positions during IV catheterizing on pain and anxiety caused
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 60 years old; the patient needs to be embedded the catheter; along with the embedded the catheter, another painful intervention is not possible; the IV catheterizing does not ban the use of the catheter way about him; consent to participate in the research. Exclusion criteria: If the IV catheterizing fails or needs to be the two vessels be taking; patients needs to new catheter, except pink one (at the discretion of the physician); no consent to continued participation in research; limitations to move; according to the discretion of the doctor's he can changes his positions in during intervention.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak university of medical science
Street address
Arak, Sardasht,arak university of medical science,the college of nursing and midwifery
City
Arak
Postal code
Approval date
2015-02-12, 1393/11/23
Ethics committee reference number
23-175-93

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified

2

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
pain
Timepoint
after intervention
Method of measurement
pain observation scale

Secondary outcomes

1

Description
anxiety
Timepoint
before and after intervention
Method of measurement
anxiety observention scale

Intervention groups

1

Description
patient in study will be selected and will be randomly divided into 2 groups that’s In intervention group supine positionwill be taking IV catheterizing, Before and after the IV catheterizing anxiety and, pain after the IV catheterizing will be research.
Category
Other

2

Description
In the control group sitting position will be taking IV catheterizing, Before and after the IV catheterizing anxiety and, pain in both groups after the IV catheterizing will be research.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Ms Hajian Leila
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university of medical science
Full name of responsible person
Dr Rafii
Street address
College of nursing and midwifery,Sardasht,Arak,Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
college of nursing and midwifery
Full name of responsible person
Mahmoudi Mokhtar
Position
Msc in nursing
Other areas of specialty/work
Street address
College of nursing and midwifery,Sardasht,Arak,Iran
City
Arak
Postal code
Phone
+98 86 3278 0817
Fax
Email
mokhtar.mahmoudi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak medical university
Full name of responsible person
Mahmoudi Mokhtar
Position
Msc in nursing
Other areas of specialty/work
Street address
College of nursing and midwifery,Sardasht,Arak,Iran
City
Arak
Postal code
Phone
+98 86 3278 0817
Fax
Email
mokhtar.mahmoudi@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Colege of nursing and midwifery of arak
Full name of responsible person
Mahmoudi Mokhtar
Position
Msc in nursing
Other areas of specialty/work
Street address
College of nursing and midwifery,Sardasht,Arak,Iran
City
Arak
Postal code
3813111956
Phone
+86 32780817
Fax
Email
www.mahmodimokhtar85@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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