Assessment affection of cold gel pack application on the sternal incision and pleural chest tube insertion site on the pulmonary function and pain due to coughing and deep breathing in coronary artery bypass graft surgery patients
Study Objective:
Assessment affection of cold gel pack application on the sternal incision and pleural chest tube insertion site on the pulmonary function and pain due to coughing and deep breathing in coronary artery bypass graft surgery patients
The trial will be conducted randomized parallel design
Study Population: Patients undergoing open heart surgery in Madani hospital
A) Inclusion Criteria
1- The patient consent to participate in the study.
2- The patient is over 40 years old.
3- The patient is able to read and write.
4- The patient can speak Farsi and Azari.
5- The patient orient to person, place and time.
6- The patient is able t use pain scale.
7- The patient has been underwent coronary artery bypass surgery ( with or without valve replacement ) with median sternutomy located.
B) Exclusion criteria
1- The patient has a history of allergy or sensitivity to cold.
2- The patient has a history of Raynaud 's syndrome , sickle cell anemia , Cryoglobulinemia , diabetes and delirium.
3- The patient has severe visual, hearing and speech impairment.
4- The patient is connected to a ventilator at the time of data collection.
5- The patient has been ill at the time of data collection.
6- The patient has postoperative complications such as infection , bleeding , uncontrolled atrial fibrillation and opening the wound edges.
The sample size: 25 people for each groups.
In this study, patients who underwent coronary artery bypass surgery with median sternutomy randomly used cooling gel bag or gel bag with room temperature.
Data on the afternoon of the first day of practice will be collected.
The pain in both groups will be measured before of use of the gel pack and at the end coughing and deep breathing by the researcher with numerical pain rating scale.
lung volumes are measured by Spirometery in three times before surgery and before and after applying the gel and coughing and deep.
study time: 20 minutes.
Expected Outcome: change in pain and pulmonary function results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502049422N9
Registration date:2015-03-15, 1393/12/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Aram Feizi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1336 5836
Email address
aramfeizi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia Medical Science University
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment affection of cold gel pack application on the sternal incision and pleural chest tube insertion site on the pulmonary function and pain due to coughing and deep breathing in coronary artery bypass graft surgery patients
Public title
Effects of cold on the pain
Purpose
Treatment
Inclusion/Exclusion criteria
A) Inclusion Criteria
1- The patient consent to participate in the study.
2- The patient is over 40 years old.
3- The patient is able to read and write.
4- The patient can speak Farsi and Turkish.
5- The patient orient to person, place and time.
6- The patient is able t use pain scale.
7- The patient has been underwent coronary artery bypass surgery ( with or without valve replacement ) with median sternutomy located.
B) Exclusion criteria
1- The patient has a history of allergy or sensitivity to cold.
2- The patient has a history of Raynaud 's syndrome , sickle cell anemia , Cryoglobulinemia , diabetes and delirium.
3- The patient has severe visual, hearing and speech impairment.
4- The patient is connected to a ventilator at the time of data collection.
5- The patient has been ill at the time of data collection.
6- The patient has postoperative complications such as infection , bleeding , uncontrolled atrial fibrillation and opening the wound edges.
Age
From 40 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Medical Science University
Street address
Central Building of Medical science, Golgasht Avenue, Azadi Street, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
93160
Health conditions studied
1
Description of health condition studied
Pain in patients undergoing coronary artery surgery
ICD-10 code
R07.1
ICD-10 code description
Chest pain on breathing
2
Description of health condition studied
pulmonary function tests
ICD-10 code
R94.2
ICD-10 code description
Abnormal results of pulmonary function studies
Primary outcomes
1
Description
pain
Timepoint
before and 20 minutes after intervention
Method of measurement
numeric pain scale
2
Description
pulmonary function results
Timepoint
before of operation /before of use of ice packed/ 20 minutes after use of ice packed
Method of measurement
spirometry
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the cooling gel pack with dimensions (10 × 25 cm) that is placed at room temperature and the timer is set for 20 minutes for the control group. Then, gel pack is placed in the dressing on the sternum incision site and around the pleural chest tube. A pillow or folded sheet will be given to the patient to support and immobilize the wound site before coughing or deep breathing. Gel pack is removed in 20 minutes and head of the bed elevated to 45-90 degrees for coughing and deep breathing.
Pain intensity will be measured by a researcher using numerical pain scale, before and after applying gel pack at the end of coughing and deep breathing in the control group. The lung volumes are measured by using spirometry three times; before surgery, before and after applying the gel pack and coughing and deep breathing. Data will be collected in the afternoon of the first day after the operation.
Category
Treatment - Other
2
Description
In this study, the cooling gel pack with dimensions (10 × 25 cm) that has been frozen for at least one hour (reaching a pack’s temperature between 0 to - 5°C) is removed from the freezer and the timer is set for 20 minutes in the intervention group. Then, gel pack is placed in the dressing on the sternum incision site and around the pleural chest tube. A pillow or folded sheet will be given to the patient to support and immobilize the wound site before coughing or deep breathing. Gel pack is removed in 20 minutes and head of the bed elevated to 45-90 degrees for coughing and deep breathing.
Pain intensity will be measured by a researcher using numerical pain scale, before and after applying the gel pack at the end of coughing and deep breathing in the intervention group. The lung volumes are measured by using spirometry three times; before surgery, before and after applying the gel pack, and coughing and deep breathing. Data will be collected in the afternoon of the first day after the operation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani hospital
Full name of responsible person
Feizi Aram
Street address
Madani hospital, In front of Research and Development complex of University, University Street, Tabriz, East Azarbaijan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urima Medical Sience University
Full name of responsible person
Mohebi Iraj
Street address
Research and Technology Assistance Building,University Staff,End of The Emergency Center,Resalat Blvd., Urmia, West Azarbaijan
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urima Medical Sience University
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
Madani hospital, Tabriz Medical Science University
Full name of responsible person
Noorellahi Davod
Position
Msc in Critical Care Nursing
Other areas of specialty/work
Street address
Madani hospital, In front of Research and Development complex of University, university street, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Phone
+98 41 3335 7771
Fax
Email
msc_ccn@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia Nursing and Midwifery School
Full name of responsible person
Feizi Aram
Position
Phd in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nazlo complex, 11 km Serov, Urmia, West Azarbaijan
City
Urmia
Postal code
Phone
+98 44 3275 4961
Fax
Email
aramfeizi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia Nursing and Midwifery School
Full name of responsible person
Feizi Aram
Position
Phd in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nazlo complex, 11 km Serov, Urmia, West Azarbaijan
City
Urmia
Postal code
Phone
+98 44 3275 4961
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)