Effect of Applying Cooling Gel Pad Compared with not using it on reducing the pain of sternal incision associated with deep breathing and coughing in cardiac surgery patient
This study is a randomized Crossover trial which was performed to assess the impact of Applying Cooling Gel Pad on the pain of sternal incision associated with deep breathing and coughing in cardiac surgery patient. For this purpose, 50 eligible (more than 21 years age, patients scheduled to undergo Coronary artery bypass graft surgery and oriented) and consenting patients were recruited and randomly allocated to intervention and control group on post-surgical first day. All Patients performed four episodes of deep breathing and coughing (two with the cooling gel pack and two without cooling gel pack), every two hours. In the intervention group intensity and quality of pain, Saturation percentage Oxygen arterial blood, blood pressure and heart rate were measured before and after intervention and in the control group above measurements have done before and after deep breathing and coughing. The level of anxiety in both group were measured and compared. At the end of the fourth session, all patients were asked to describe their sensations with the cooling gel pack and their preferences for the gel pack application prior to deep breathing and coughing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207249422N2
Registration date:2012-08-19, 1391/05/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-19, 1391/05/29
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 University of Medical Sciences
Expected recruitment start date
2012-06-22, 1391/04/02
Expected recruitment end date
2012-07-23, 1391/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Applying Cooling Gel Pad Compared with not using it on reducing the pain of sternal incision associated with deep breathing and coughing in cardiac surgery patient
Public title
Effect of Applying Cooling Gel Pad on the pain of sternal incision associated with deep breathing and coughing.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: more than 21 years age; able to speak and understand Persian; The minimum literacy of Reading and writing; Willing to give written informed consent; male or female patients scheduled to undergo Coronary artery bypass graft surgery with or without a valve replacement using a median sternotomy. Exclusion criteria: Mechanically ventilated patients; diseases that affect pain measurement (Delirium; Dementia or Major depression; Severe visual, hearing and verbal impairment; diabetic patient) contradictions to cryotherapy use such as ( Reynaud’s disease; cryoglobulinemia; sickle cell anemia; cold allergic conditions and in
areas with impaired sensation); bilateral mammary harvest; postoperative complications such as (infection; bleeding; uncontrolled Atrial fibrillation or wound dehiscence).
Age
From 21 years old to 75 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
not uesd
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Boulevard
City
Urmia
Postal code
Approval date
2012-07-18, 1391/04/28
Ethics committee reference number
پ6/91/4/22626
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I20-125
ICD-10 code description
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Immediately before the application of cooling gel pack and after termination of DB & C sessions in intervention group and Immediately before and after DB & C sessions in control group.
Method of measurement
numeric rating scale (NRS)
Secondary outcomes
1
Description
Anxiety
Timepoint
At the beginning application of cooling gel pack and before deep breathing and coughing.
Method of measurement
State –Trait Anxiety Inventory
2
Description
Quality of pain
Timepoint
Immediately before the application of cooling gel pack and after termination of DB & C sessions in intervention group and Immediately before and after DB & C sessions in control group
Method of measurement
Modified short form MacGill pain Questionnaire
3
Description
blood pressure and heart rate
Timepoint
Immediately before the application of cooling gel pack and after termination of DB & C sessions in intervention group and Immediately before and after DB & C sessions in control group.
Method of measurement
Cardiac monitoring machine
4
Description
Spo2
Timepoint
Immediately before the application of cooling gel pack and after termination of DB & C sessions in intervention group and Immediately before and after DB & C sessions in control group.
Method of measurement
Pulse Oxy-meter
Intervention groups
1
Description
Intervention group: application of cooling gel pack before deep breathing and coughing sessions.
Category
Other
2
Description
Control group: deep breathing and coughing sessions without application of cooling gel pack