Objective: The aim of this study is to evaluate the effect of cold compress on the severity of pain and confort of patients undergoing heart surgery.Design: A randomized clinical trial . Setting:This study included three groups of 120 patients undergoing cardiac surgery will be performed. Each group consist of 40 patients. Allocation of samples will be done by using simple random with table of random numbers. Intervention: In the intervention group 20 minutes before removing the tube will apply cold compresses. In the placebo group, in addition to the conventional method, the ring with same body temperature will be used. The Control group will not receive any intervention. Immediately before, during and 5 minutes after removal of chest tube drainage, pain and patient comfort will be measured with visual analog scale (VAS). Inclusion criteria included: People with coronary artery disease who underwent open-heart surgery; The absence of drug addiction. Exclusion criteria included Patient dissatisfaction continued cooperation and addiction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013025929N4
Registration date:2017-04-15, 1396/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-15, 1396/01/26
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Hamedan University of Medical Sciences
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cold compress on comfort and pain severity during chest tube removal in patients after cardiac surgery
Public title
cold therapy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: People with coronary artery disease who underwent open-heart surgery have been;The absence of drug addiction.
Exclusion criteria: Patient dissatisfaction continued cooperation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethic committee of Hamedan University of Medical Sciences
Street address
hamadan
City
hamadan
Postal code
Approval date
2017-02-20, 1395/12/02
Ethics committee reference number
IR.UMSHA.REC.1395.525
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R07.3
ICD-10 code description
Anterior chest-wall pain NOS
Primary outcomes
1
Description
pain
Timepoint
Before and 5 minute after intervention
Method of measurement
questionnaire VAS
Secondary outcomes
1
Description
comfort
Timepoint
before and 5 minutes after intervention
Method of measurement
Questionnaire VAS
Intervention groups
1
Description
In the intervention group cold compresses ring will be placed 20 minutes before removal of chest tube.
Category
Treatment - Other
2
Description
control group: certain actions will not be taken.
Category
Treatment - Drugs
3
Description
placebo group: The ring with body temperature will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besaat Hospital
Full name of responsible person
Mehdi Hatami
Street address
Shahid Fahmideh street, University of Medical Sciences, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamedan University of Medical Sciences
Full name of responsible person
Akram Mirzaei
Street address
Shahid Fahmideh street, University of Medical Sciences, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Hamedan 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
Hamadan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
phd
Other areas of specialty/work
Street address
Shahid Fahmideh street, University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 0439
Fax
Email
oshvandi2005@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
khodayar Oshvandi
Position
phd
Other areas of specialty/work
Street address
Shahid Fahmideh street, University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 0439
Fax
Email
oshvandi2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master oh Science
Other areas of specialty/work
Street address
Shahid Fahmideh street, University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3422 5650
Fax
Email
M.MOLAVI@UMSHA.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)