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Effect of Changing weight of sand bag on some complications of femoral artery puncturation and patients comfort on patient undergoing coronary angiography in Kordkooy Amir-almomenin Hospital1392

Protocol summary

Summary
1)Objectives: To assess the effect of Changing weight of sand bag on the bleeding, hematoma, back pain, urinary retention and Patient comfort after cardiac catheterization. 2) Design: This is a quasi-experimental study, including four groups of 35 patients (140 samples with random sampling). 3)Setting and conduct:Patients were randomly assigned to intervention and control groups are examined. 4)Participants including major eligibility criteria:Inclusion criteria: non-emergency catheterization; withdrawal of arterial sheath immediately after angiography; aged 18-65; informed consent to participate in the study. Exclusion criteria: the need for cardiopulmonary resuscitation during angiography; vascular injury during the procedure; patient unwillingness to participate in the study. 5)Intervention:The control group received a common protocol, will be the use of sandbags is 4 kg to 6 hours. Patients in the intervention group of sandbags weighing 3/5, 3 and 2/3 will be used for 6 hours. 6)main outcome measures (variables): the amount of bleeding, hematoma, back pain, urinary retention and Patient comfort were measured in 0, 1, 2, 4, 6,8 and 24 hours after angiography. Data were collected by the use of personal information questionnaire and Numeric Pain Intensity Scale and Christenson check list for investigating the amount of bleeding and hematoma and Visual comfort scale .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013052213424N1
Registration date: 2013-06-25, 1392/04/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-25, 1392/04/04
Registrant information
Name
Afiyeh Kor
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6689 7622
Email address
korafiyeh1@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Changing weight of sand bag on some complications of femoral artery puncturation and patients comfort on patient undergoing coronary angiography in Kordkooy Amir-almomenin Hospital1392
Public title
Effect of Changing weight of sand bag on some complications of coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: non-emergency catheterization of the femoral artery and catheter 6fr build a company; withdrawal of arterial sheath immediately after angiography; aged 18-65; systolic blood pressure less than 180 and a diastolic pressure of less than 100; the lack of bleeding disorders Off; Pt <16, ptt <50, INR <1/8; the absence of peripheral vascular disease; no history of previous low back pain; lack of experience difficulty passing urine; loss of cerebrovascular accidents and motor and neuromuscular problems; lack of angioseal, BMI 18/5-29; informed consent to participate in the study. Exclusion criteria: the need for angiography during cardiopulmonary resuscitation; chest pain with new ECG changes; hemodynamic changes associated with active bleeding and need for blood transfusion; dangerous arrhythmias immediately after cardiac catheterization; vascular injury during the procedure; hemostasis time after the procedure; a long (over 20 minutes); use of pain medications; heparin infusion during or after catheterization; manipulating both the femoral artery and arterial catheter in place for more than 2 times; patient unwillingness to participate in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, 5 km road Gorgan - Sari, Gorgan, Golestan, Iran
City
Gorgan
Postal code
49165-568
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
356191122716

Health conditions studied

1

Description of health condition studied
cardiac catheterization
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
bleeding
Timepoint
On arrival the patient, every 2 hours for 8 hours and then 24 hours later
Method of measurement
Christenson check list

2

Description
Hematoma
Timepoint
On arrival the patient, every 2 hours for 8 hours and then 24 hours later
Method of measurement
Christenson check list

3

Description
pain
Timepoint
On arrival the patient, every 2 hours for 8 hours and then 24 hours later
Method of measurement
Numeric pain scale

4

Description
Urinary retention
Timepoint
On arrival the patient, every 2 hours for 8 hours and then 24 hours later
Method of measurement
Question of patient

5

Description
Comfort
Timepoint
On arrival the patient, every 2 hours for 8 hours and then 24 hours later
Method of measurement
Visual scale Comfort

Secondary outcomes

1

Description
protromobin time (PT)
Timepoint
Before intervention
Method of measurement
second

Intervention groups

1

Description
control group: patients who received routine care, including the use of sandbags is 4 kg to 6 hours.
Category
Prevention

2

Description
Intervention group 1:The sandbags 3/5 kg was used for 6 hours
Category
Prevention

3

Description
Intervention group 2:The sandbags 3 kg was used for 6 hours
Category
Prevention

4

Description
Intervention group 1:The sandbags 2/3 kg was used for 6 hours
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir-al-momenin hospital
Full name of responsible person
Afiyeh Kor
Street address
Jangal St, KordKooy, Golestan, Iran
City
Kordkooy

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Golestan University of Medical Sciences
Full name of responsible person
Dr MJ Golalipour
Street address
Golestan University of Medical Sciences, 5 km road Gorgan - Sari, Gorgan, Golestan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Golestan University of Medical Sciences
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
Golestan University of medical Sciences
Full name of responsible person
Afiyeh Kor
Position
Bachelor of Science
Other areas of specialty/work
Street address
Golestan University of medical Sciences, 5 km road Gorgan - Sari, Gorgan, Golestan
City
Gorgan
Postal code
Phone
+98 21 6689 7622
Fax
Email
korafiyeh1@gmail.com; korafiyeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Khadije Yazdi
Position
Master of Science
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, 5 km road Gorgan - Sari, Gorgan, Golestan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
yazdikh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Afiyeh Kor
Position
Bachelor of Science
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, 5 km road Gorgan - Sari, Gorgan, Golestan
City
Gorgan
Postal code
Phone
+98 21 6689 7622
Fax
Email
korafiyeh1@gmail.com; korafiyeh@yahoo.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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