Objectives: The effect of leg elevation on prevention of leg pain and edema and anxiety among patients undergoing coronary artery bypass grafting. Design: This study is a randomized controlled clinical trial on patients undergoing CABG. In order to compare the average scores of edema pain and anxiety in the intervention group and the control group. Samples will be selected from all patients undergoing CABG hospital admission. After a preliminary study to determine the sample size and the justification of eligible patients, purpose of the study will be explained to patients. After preparing the list of the day after operation candidates, researcher will go to ward (between the hours 17-19) to fill the questionnaires. Participants: Patients undergoing CABG. Intervention: The samples using random numbers table will be divided into two groups. Leg elevating Intervention will begin after surgery in the ICU and will continue to operation ward. We will put pillow under leg that is graft donor. If only one leg is vein donor the leg elevation will be done by putting pillow under foot and if both feet are vein donor, raising the foot of the bed to 30 degrees will be carried out. The control group will receive no intervention. Recollecting data related for pain, anxiety and edema in discharging from the ICU and discharging from ward will be carried out by research assistant in both groups. Main outcome measures variables: Demographic Spielberger State Anxiety Scale and Visual Analogue Scale and the incidence of Edema.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051412264N3
Registration date:2016-12-03, 1395/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-03, 1395/09/13
Registrant information
Name
Farahnaz Abdollahzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 0648
Email address
abdollahzadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-07-19, 1395/04/29
Expected recruitment end date
2016-11-19, 1395/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of leg elevation on prevention of leg pain and edema and anxiety among patients undergoing coronary artery bypass grafting
Public title
The effect of leg elevation on prevention of leg pain and edema and anxiety among patients undergoing coronary artery bypass grafting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing coronary artery bypass grafting; The ability to read and write to complete the anxiety questionnaire; age (between 18 and 70 years); Lack of movement problems; The absence of an underlying disease such as renal failure, congestive heart failure, deep vein thrombosis, absence of edema and varicose veins in the lower extremities, lack of oral contraceptive drugs
Exclusion criteria: pulmonary embolism; immobility before surgery; Cancel patients to participate in research
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The samples using random numbers table will be divided into two groups.
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences; Golgasht Avenue.
following cardiac surgery or due to presence of cardiac prosthesis
Primary outcomes
1
Description
Anxiety
Timepoint
The day before surgery, discharge from ICU, discharge from the public sector
Method of measurement
Spielberger questionnaire
2
Description
Leg edema
Timepoint
The day before surgery, discharge from ICU, discharge from the public sector
Method of measurement
Centimeter
3
Description
Leg pain
Timepoint
The day before surgery, discharge from ICU, discharge from the public sector
Method of measurement
VAS Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Leg elevation Intervention will be done after surgery and in the ICU and will be continued in operation ward. It will take place on the Foot that is graft donor. If only one leg is vein donor, leg elevation will be done by putting pillows under foot and if both feet are vein donor, leg elevation will be done by bringing up the head part of bed about 30 degrees .
Category
Other
2
Description
Control group: The control group will receive no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Ms. Roghayeh Pourali
Street address
University Avenue,Shahid Madani Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Doctor Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht Avenue. Tabriz
City
Tabriz
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 Tabriz 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
Kosar Dormitory, Shariati Avenue. Tabriz
Full name of responsible person
Farahnaz Abdolahzadeh
Position
Masters of Sciences
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue. Tabriz
City
Tabriz
Postal code
Phone
+98 41 3479 6707
Fax
Email
F_abdollahzadeh@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.
Full name of responsible person
Farahnaz Abdollahzadeh
Position
Master of Sciences
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue. Tabriz
City
Tabriz
Postal code
Phone
+98 41 3479 6707
Fax
Email
F_abdollahzadeh@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rougayeh Pourali
Position
Masters of Sciences Student
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue. Tabriz
City
Tabriz
Postal code
-
Phone
Fax
Email
rogi.pourali@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)