Protocol summary

Summary
This study was conducted to evaluate the effects of chest physiotherapy by nurses on pain, oxygenation, and hemodynamic indexes and inspiratory capacity in patients after coronary artery bypass surgery . In this controlled clinical trial, 60 patients undergoing open heart surgery at the hospital of Imam Reza (AS) in Mashhad will be selected with available sampling method and then randomly will be divided into two groups (physiotherapy by nurses and physiotherapy by routine group (physiotherapists)) . variables Such as pain, hemoglobin oxygen saturation, p/f ratio, mean arterial pressure, heart rate, pulse pressure and inspiratory capacity before, during and after intervention in both groups will be measured; and then within group and between group Comparison will be done.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020820994N1
Registration date: 2015-06-15, 1394/03/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Hadi Roshani Yosefabad
Name of organization / entity
Nursing and Midwifery Faculty, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3657 3198
Email address
roshanih1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
mashhad university of medical science
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of respiratory physiotherapy by nurses on pain, oxygenation, hemodynamic indexes and inspiratory capacity after coronary artery bypass surgery
Public title
The effect of physiotherapy in the prevention of complications after surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include: patients undergoing coronary artery bypass surgery without cardiopulmonary pump technique, hemodynamic conditions are stable and do not have preoperative pulmonary diseases. Exclusion criteria include: during the study hemodynamic situation is unstable and during the study there is need to intubation, CPR, or receiving inotropic support.
Age
From 18 years old to 65 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The committee ethics in research Mashhad University Of Medical Science
Street address
Research ethics committee, GHorayshi building, University Avenue, Mashhad,Iran
City
Mashhad
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
930481

Health conditions studied

1

Description of health condition studied
physiotherapy
ICD-10 code
z50
ICD-10 code description
Care involving use of rehabilitation procedures

Primary outcomes

1

Description
Pain
Timepoint
Before, during and immediately after the intervention
Method of measurement
Numerical Rating Scale of pain

2

Description
Oxygen Saturation Of Hemoglobin
Timepoint
Before, during and immediately after the intervention
Method of measurement
Pulse oxymetry

3

Description
P/F Ratio
Timepoint
Befor and immediately after the intervention
Method of measurement
With formula ( Pao2/Fio2 )

4

Description
Mean Arterial Pressure (MAP)
Timepoint
Before, during and immediately after the intervention
Method of measurement
With monitoring of saadat

5

Description
Heart Rate
Timepoint
Before, during and immediately after the intervention
Method of measurement
With monitoring of saadat

6

Description
Pulse Pressure
Timepoint
Before, during and immediately after the intervention
Method of measurement
With formula ( systolic blood pressure- diastolic blood pressure )

7

Description
Inspiratory Capacity
Timepoint
Befor and immediately after the intervention
Method of measurement
With volumetric exerciser model : respiflo vs 5000

Secondary outcomes

empty

Intervention groups

1

Description
Chest physiotherapy with nursing protocol of physiotherapy intervention ( in intervention group )
Category
Prevention

2

Description
Chest physiotherapy by physiotherapist ( control group )
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza(A.S.) Hospital
Full name of responsible person
Hadi Roshani
Street address
Nursing and Midwifery Faculty, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr. Saeed Eslami
Street address
GHorayshi building, Daneshghah avenue, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Nursing and Midwifery Faculty
Full name of responsible person
Hadi Roshani
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
roshanih1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Hamid CHamanzari
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
chamanzarih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Hadi Roshani
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
roshanih1@mums.ac.ir
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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