Comparison and combination the effect of TENS and cold application on pain during chest tube removal among coronary artery bypass grafting (CABG) patient in Shafa hospital of Kerman in 2019.
Determine and comparison of the effects of tense, cold compress and their combination on pain during extraction of chest tube in CABG patients
Design
The study is a one-way blind clinical trial in patients undergoing cardiac surgery in the ICU of the heart. The sampling method will be available and the allocation of samples will be done randomly in four groups.
Settings and conduct
The site of the study is cardiac ICU in the Shafa hospital, Kerman, Iran.
Participants/Inclusion and exclusion criteria
Entry requirements include age of over 18 years old; full awareness of time and place and person; absence of bans on receiving trance; non-sensory hearing impairment and vision and no addiction to drugs.
Intervention groups
Cold compresses, tenes, tennis compound and cold compressors
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N18
Registration date:2020-06-13, 1399/03/24
Registration timing:retrospective
Last update:2020-06-13, 1399/03/24
Update count:0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and combination the effect of TENS and cold application on pain during chest tube removal among coronary artery bypass grafting (CABG) patient in Shafa hospital of Kerman in 2019.
Public title
A Comparative Study on the Effect of Tenes, Cold Compressors and their Combination on Pain During Chest Tube Discharge
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Complete vigilance about time and place and departure from the study: Patient's reluctance to continue participating in the study
No Tens In Ban
Lack of sensory hearing and vision impairment and non-addiction to drugs
Exclusion criteria:
Patient death
No desire to continue participating in the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
This randomized clinical trial study was performed with the participation of 120 patients undergoing open heart surgery, using block randomization method (quadruple blocks) which were assigned to four groups of 30 people by the patient's software for intervention and control
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the person assessing the pain will be blind to the use of intervention
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Kerman
Province
Kerman
Postal code
7717676563
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.RUMS.REC.1397.174
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Pain
Timepoint
Before, during and after the removal of the chest tube
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In a cold compressed group, a 2 × 4 × 2 piece of lacquered gloves was placed in the lacquer glove and taken 5 minutes before removing the cyst tube in place
Category
Prevention
2
Description
Intervention group 2: In tennis group 15 minutes before removing the chest tube, the electrodes of the tennis machine are connected to the sides of the chest tube in parallel with the frequency of 80-100 Hz
Category
Prevention
3
Description
Intervention group 3: In the cold-tennis compressor group, 15 minutes before removing the chest tube, the electrodes of the tennis apparatus and at least 5 minutes before the cold compression are removed.:
Category
Prevention
4
Description
control group, embedded electrodes will be used while the machine is off and a non-cooled casket in the latex gloves will be used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Healing Hospital
Full name of responsible person
Dr. Majid Kazemi
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717676563
Phone
+98 34 3428 0001
Fax
Email
dr.kazemi.n@rums.ac.ir
Web page address
https://rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Ali Shamsi
Street address
Imam Ali Blvd
City
Kerman
Province
Kerman
Postal code
7717676563
Phone
+98 34 3428 0086
Email
ashamsi@rums.ac.ir
Web page address
http://rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Hatefi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Abolfazl Blvd
City
Kerman
Province
Kerman
Postal code
7617413479
Phone
+98 34 3428 0001
Email
hatefei86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd Medical University
City
Rafsanjan
Province
Kerman
Postal code
7717676563
Phone
+383 4283498
Fax
Email
Maj_kaz@yahoo.com
Web page address
http://rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jomhori street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3428 0001
Email
maj_kaz@yahoo.com
Web page address
https://rums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available