The aim of this study is to investigate the effect of Ice application on intensity and quality of pain during Chest tube removal (CTR). Design of this study is single-blinded randomized crossover. The subjects act as their own controls. Pain intensity in three stages and pain quality in two stages by helping the researcher will be measured. Sample is 51 patients who are undergoing cardiac surgery in Mashhad University Hospital. Verbal and written informed consent is obtained from each of the patients for the present study. Patient have two chest tubes (pericardial and thoracic tube) that distance between them is more than 8-10 cm, patient able to verbally report their pain and understand visual analog scale. The patients were excluded that don’t desire to participate in the study or had received narcotics 2 hours ago. Patients randomly assigned to three groups, Group 1: Ice and placebo bags application group; Group 2: Ice bag application and without application; Group 3: placebo application and without application. Ice bags (zero to -5 - 0° C) and placebo (18 - 22° C) is designed by the researcher. Ice and placebo bags will apply to the area surrounding the chest tubes for 20minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105146484N1
Registration date:2011-06-07, 1390/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-07, 1390/03/17
Registrant information
Name
Fatemeh Gandomkar
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8019
Email address
gandomkarf881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences Vice chancellor for research
Expected recruitment start date
2011-01-20, 1389/10/30
Expected recruitment end date
2011-06-20, 1390/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ice bag on pain associated with chest tube removal after cardiac surgery.
Public title
The effect of ice on reduce of pain
Purpose
Supportive
Inclusion/Exclusion criteria
Eligible participants include adult patients who had cardiothoracic surgery; Could speak Persian and able to verbally report their pain; Have two chest tube (pericardial and thoracic tube); Orient to place, person and time; Don’t have co morbidity to effect pain such as, delirium, severe depression, severe visual defect; Had chest tube at least 24 hours; Don’t connect to ventilator and are Iranian and Muslim; Patient had pericardial and pleural chest tube that distance between them is more than 8-10 cm. Exclusion criteria include patient refusal; Sedative drugs infusion; Chest tubes were removed more than three minutes of discontinuation of the intervention; Time between remove two chest tube is less than 30 minutes; Take opioid drugs 2 hours ago chest tube removal.
Age
To 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
1
Registry name
no
Secondary trial Id
no
Registration date
empty
2
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mashhad University of Medical Science
Street address
Ghoraishy Building, University St, Mashhad
City
Mashhad
Postal code
Approval date
2011-01-03, 1389/10/13
Ethics committee reference number
89359
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52, R52.0
ICD-10 code description
Pain, not elsewhere classified, Acute pain
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before chest tube removal, Immediately and 15 minutes after chest tube removal
Method of measurement
Visual Analog Scale
2
Description
Pain Quality
Timepoint
Before chest tube removal, Immediately after chest tube removal
Method of measurement
Modify Short Form McGill Pain Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This clinical trial consists of three groups. The patients are divided to three groups randomly assigned; Group 1: tubes (pericardial and thoracic tube) randomly assigned for Ice bag (zero to 5 ° C) and placebo bag (22-18 ° C) application. Ice and placebo bags designed by the researcher. Ice and placebo bags apply to the area surrounding the chest tubes for 20minutes. Time between two chest tubes removal is 30 minutes.
Category
Other
2
Description
Group 2: Tubes (pericardial and thoracic tube) randomly assigned for Ice bag (zero to 5 ° C) and control (without anything application). Ice bag applies to the area surrounding the chest tube for 20minutes. Time between two chest tubes removal is 30 minutes.
Category
Other
3
Description
Group 3: Tubes (pericardial and thoracic tube) randomly assigned for placebo bag (zero to 5 ° C) and control (without anything application) placebo bag (22-18 ° C) applies to the area surrounding the chest tube for 20minutes. Time between two chest tubes removal is 30 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyed Reza Mazloum
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences Vice chancellor for research
Full name of responsible person
Dr. Jalil Tavakol Afshari
Street address
Ghoraishy Building, University St, Mashhad.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences Vice chancellor for research
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
Mashhad University Of Medical Science
Full name of responsible person
Syed Reza Mazloum
Position
PhD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing, Mashhad.
City
Mashhad
Postal code
Phone
+98 51 1859 8019
Fax
Email
mazlomr@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Science
Full name of responsible person
Syed Reza Mazloum
Position
PhD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing, Mashhad.
City
Mashhad
Postal code
Phone
+98 51 1859 8019
Fax
Email
mazlomr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Fatemeh Gandomkar
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing, Mashhad.
City
Mashhad
Postal code
Phone
Fax
Email
gandomkarf881@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)