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Effect of Valsalva maneuver during arterial sheath removal on pain intensity in patients undergoing coronary artery angioplasty

Protocol summary

Study aim
The purpose of this study is to investigate the effect of Valsalva's maneuver during arterial catheter withdrawal on the severity of pain in patients undergoing coronary angioplasty.
Design
Clinical trials with randomized control group
Settings and conduct
This is a clinical trial in which eligible patients undergoing angioplasty in Tehran's Mohab Hospital. In the test group, the arterial sheet is removed during the Valsalva maneuver and in the control group removed it without any intervention.
Participants/Inclusion and exclusion criteria
Age between 40 to 70 years, angioplasty through the femoral artery ,conscious patients, having the ability to communicate, the lack of a history of drug use, the respiratory problems, cerebral problems, glaucoma, lack of high intra cranial brain pressure , recent eye surgery
Intervention groups
In the test group the patients performed a Valsalva maneuver it meanes blowing in a plastic tube connected to a mercury column and raise the mercury column 25-20 mmHg for at least 10 seconds and at the same time,the sheat will be removed
Main outcome variables
The pain of the patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110430006342N8
Registration date: 2019-01-26, 1397/11/06
Registration timing: prospective

Last update: 2019-01-26, 1397/11/06
Update count: 0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Valsalva maneuver during arterial sheath removal on pain intensity in patients undergoing coronary artery angioplasty
Public title
Effect of Valsalva maneuver on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 to 70 years Angioplasty through the femoral artery Conscious patients, having the ability to communicate lack of a history of drug use lack of history of respiratory problems, cerebral problems, glaucoma, lack of high intra cranial brain pressure , recent eye surgery
Exclusion criteria:
Patients who don’t have the ability to perform the Valsalva maneuver, through the holding mercury column above than 20 mm hg for 10 seconds,patients with radial artery access and , , or Patients who tried to enter the needle several times Patients with an arterial sheath larger than 6 french Patients who have dangerous arrhythmia, or hemodynamic problems
Age
From 40 years old to 70 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
Random assignment of samples in groups is done using random numbers of 24 possible modes. This random selection is placed in each of the four blocks, which are based on age (55-40, 70-56) and gender. Each number will determine four consecutive samples in each block of age and gender.
Blinding (investigator's opinion)
Not 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 Semnan University of Medical Sciences
Street address
Basij Street, Headquarters of Semnan University of Medical Sciences, Deputy Director of Research and Technology
City
Semnan
Province
Semnan
Postal code
۹۹۹۵۱- ۳۵۱۹۸
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.SEMUMS.REC.1397.232

Health conditions studied

1

Description of health condition studied
Acute ischaemic heart disease
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified

Primary outcomes

1

Description
Intensity of pain
Timepoint
Before and after intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the test group, at first the patient is requested blowing a plastic tube attached to the sphygmomanometer and hold the mercury column at 25-20 mm Hg for 10 seconds, and at the same time, the arterial sheet is removed by a experienced nurse.
Category
Treatment - Other

2

Description
Control group: Without any intervention, according to the routine, arterial catheter will be removed by an experienced nurse
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Moheb Mehr Hospital
Full name of responsible person
Akram Roshani
Street address
Valiasr Street - after Vanak Square - Khalilzadeh Alley
City
Tehran
Province
Tehran
Postal code
۱۹۶۹۷۱۳۱۹۹
Phone
+98 21 85555
Email
info@mohebmehrhospital.com
Web page address
http://mohebmehrhospital.com/index.jsp?siteid=1&fkeyid=&siteid=1&fkeyid=&siteid=1&pageid=341

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaee
Street address
Basij Street, Headquarters of Semnan University of Medical Sciences, Deputy Director of Research and Technology
City
Semnan
Province
Semnan
Postal code
۹۹۹۵۱- ۳۵۱۹۸.
Phone
+98 23 3344 1021
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
1111111111
Phone
+98 23 3365 4170
Email
aaghods@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Km6 Damghan Road, Semnan University of Medical Sciences, Semnan, Faculty of Nursing
City
Semnan
Province
Semnan
Postal code
1111111111
Phone
+98 23 3365 4170
Email
aaghods@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4170
Email
aaghods@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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