Comparing the effect of local coldness, heat and intermittent cold heat application on chest pain severity during respiratory exercise after open heart surgery in patients with coronary artery disorders
Objective: comparing the effect of local coldness, heat and intermittent cold heat application on chest pain severity during respiratory exercise in patients after open heart surgery.
Study design: randomized clinical trial.
Inclusion criteria: Patients after open heart surgery; communication ability
Exclusion criteria: Patients undergoing mechanical ventilator; sensitivity to local coldness or heat; occurring crisis condition; alteration in patient status
Sample size: 80 patients.
Blinding: not blinded
Centers: single
Study phase: 2
Intervention: Local coldness, heat and intermittent coldness-heat application.
Intervention time: 10 minutes.
Method: for performing the study, the research samples placed randomized to one of following group. The randomization is performed according to randomized block design.
The first group: application of local coldness.
The second group: application of local heat.
The third group: intermittent cold - heat application.
The fourth group: routine care.
The chest pain severity was measured before intervention and each 5 minutes during respiratory exercises, immediately after intervention or routine care (after 10 minutes of respiratory exercises), and 5 minutes after intervention or routine care. In intermittent cold heat application, at first 5 minutes’ coldness and then 5 minutes’ heat will apply.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609245134N10
Registration date:2016-10-26, 1395/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-26, 1395/08/05
Registrant information
Name
Ali Fakhr-Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4192
Email address
Alimovi49@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research and technology, Semnan University of medical sciences
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of local coldness, heat and intermittent cold heat application on chest pain severity during respiratory exercise after open heart surgery in patients with coronary artery disorders
Public title
Effect of local coldness and heat on chest pain severity after open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients after open heart surgery; communication ability
Exclusion criteria: Patients undergoing mechanical ventilator; sensitivity to local coldness or heat; occurring crisis condition; alteration in patient status
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For performing the study, the research samples placed randomized in study groups. The randomization is performed according to randomized block design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Semnan university of medical sciences
Street address
Basij Blvd; The central headquarters of the mobilization of the Boulevard, Semnan University of medical sciences, Vice President for research and technology
City
Semnan
Postal code
Approval date
2016-09-13, 1395/06/23
Ethics committee reference number
IR.SEMUMS.REC.1395.96
Health conditions studied
1
Description of health condition studied
Chest pain on breathing
ICD-10 code
R07.1
ICD-10 code description
Painful respiration
Primary outcomes
1
Description
Chest pain severity during respiratory exercises
Timepoint
before intervention and each 5 minutes during respiratory exercises, immediately after intervention or routine care (after 10 minutes of respiratory exercises), and 5 minutes after intervention or routine care
Method of measurement
Visual analog scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
The first group: application of local coldness
Category
Other
2
Description
The second group: application of local heat
Category
Other
3
Description
The third group: intermittent cold - heat application
Category
Other
4
Description
The fourth group: routine care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Dr. Abolfazle Abdollahpour
Street address
Golestan town, Amin Blvd., Kosar Hospital
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research and technology, Seman University of medical sciences
Full name of responsible person
Dr. Ali Rashidy-pour
Street address
The central headquarters of Semnan University of medical sciences, Vice Chancellor for research and technology, Basij Bvld
City
Semnan
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 and technology, Seman 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
Semnan University of medical sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Nursing PhD, Associate professor
Other areas of specialty/work
Street address
Nursing and Allied Health School, Semnan University of medical sciences, Kilometer 5, Damghan road
City
Semnan
Postal code
Phone
+98 23 3365 4192
Fax
Email
alimovi49@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan university of medical sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Nursing PhD, Associate professor
Other areas of specialty/work
Street address
Nursing and Allied Health School, Semnan University of medical sciences, Kilometer 5, Damghan road
City
Semnan
Postal code
Phone
+98 23 3365 4192
Fax
Email
alimovi49@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan university of medical sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Nursing PhD; Associate professor
Other areas of specialty/work
Street address
Damghan road, Kilometer 5, Nursing and allieh health faculty, Semnan university of medical sciences
City
Semnan
Postal code
Phone
+98 23 3365 4192
Fax
Email
alimovi49@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)