Pain with Deep Breathing & Cough (DB & C) post cardiac surgery remains an issue for nurses. This pain prevents patients from performing these activities which in turn places them at risk for pulmonary complications. Incisional pain can be managed with both pharmacologic & non pharmacologic therapies. However, pharmacologic therapies can have systemic side effects. Cold pack application is a low cost, low risk & accessible non pharmacologic pain management strategy. This research was conducted to determine the effect of cold therapy on pain, ventilation, oxygenation and hemodynamic parameters in patients undergoing coronary artery bypass graft surgery. In this research 25 patients in a randomized crossover trial were assigned to either begin the DB & C sessions with or without cold pack. Participants then alternated with respect to the cold pack. Pain scores & other variables after DB & C (two stages in any method) were compared with & without cold pack. Cold pack was applied over the chest dressing for 20 minutes before second stage of DB & C in cold pack method. Exclusion criteria: allergic or sensitive to cold, cognitive impairments, having chest tube at time of data collection, develop sever postopration complication and receiving pain medications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201038600N1
Registration date:2012-02-14, 1390/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-14, 1390/11/25
Registrant information
Name
Akbar Raeisi Estabragh
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71164742546
Email address
estabragh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery of research, Shiraz University of Medical Sciences
Expected recruitment start date
2011-08-16, 1390/05/25
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cold therapy on pain, ventilation, oxygenation and hemodynamic parameters in patients undergoing coronary artery bypass graft surgery
Public title
Effect of cold bag on pain relief
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing CABG by sternotomy. Exclusion criteria: Allergic or sensitivity to cold, cognitive impairments, having chest tube at the time of data collection, developing severe post-op complication and receiving pain medications
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand blvd
City
Shiraz
Postal code
71435-1987
Approval date
2011-08-15, 1390/05/24
Ethics committee reference number
CT-90-5645
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft
ICD-10 code
151.6
ICD-10 code description
atherosclerotic cardiovascular disease
Primary outcomes
1
Description
pain
Timepoint
2 stages with two hour interval between them in any method
Method of measurement
numerical rating scale
2
Description
sistolic and diastolic blood pressure
Timepoint
2 stages with two hour interval between them in any method
Method of measurement
analogue manometer
3
Description
pulse
Timepoint
2 stages with two hour interval between them in any method
Method of measurement
By touching and counting pulse
4
Description
Maximum inspiratory volume
Timepoint
2 stages with two hour interval between them in any method
Method of measurement
incentive spirometry
5
Description
arterial o2 suturation
Timepoint
2 stages with two hour interval between them in any method
Method of measurement
pulse oximetry
6
Description
respiratory rate
Timepoint
2 stages with two hour interval between them in any method
Method of measurement
By counting
Secondary outcomes
empty
Intervention groups
1
Description
Control group (without cold pack method): Not using cold pack (no intervention) before the first and second stages.
Category
N/A
2
Description
Intervention group (with ice bag method): Not using cold pack (no intervention) before the first stage and Using cold pack on sternotomy dressing for 20 minutes before the second stage.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr Mohamad Ghazinour
Street address
Namazi Hospital, Zand blvd, Namazi Square
City
Shiraz
2
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Dr Mohamad Ghazinour
Street address
Zand blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamrza Hatam
Street address
Shiraz University of Medical Science, Zand blvd
City
Shiraz
Grant name
Grant code / Reference number
CT-90-5645
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Soltani Shirazi
Position
MSc. of nursing, lecturer
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School of Nursing & Midwifery, Zand blvd
City
Shiraz
Postal code
Phone
+98 71 1647 4255
Fax
+98 71 1647 4252
Email
Soltanif@Sums.ac.ir , Far15us@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Soltani Shirazi
Position
MSc. of nursing, lecturer
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School of Nursing & Midwifery, Zand blvd
City
Shiraz
Postal code
Phone
+98 71 1647 4255
Fax
+98 71 1647 4252
Email
Soltanif@Sums.ac.ir , Far15us@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Akbar Raeisi Estabragh
Position
Master science student
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School of Nursing & Midwifery, Zand blvd
City
Shiraz
Postal code
Phone
+98 34 5423 6019
Fax
+98 71 1647 4252
Email
Estabragh@Sums.ac.ir , Raisi_Akbar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)