Background: Pain and fatigue are complications after coronary artery bypass graft surgery. Because of non- pharmacological methods are the preferred pharmacological agent therefore; the purpose of this study was assessment of effect of foot reflexology on pain and fatigue in patients undergoing CABG.
Methods: This study was a randomized controlled clinical trial, conducted on 80 patients hospitalized in the Heart Center of Mazandaran in 2011. Sampling was in manner of Non-random and accessible. Patients were age and sex matched and divided randomly in two equal groups of case and control. The reflexology group received 20- minutes left foot massage, from the second day after surgery for 4 consecutive days. In the control group, patient's left foot without applying any pressure and only for 1 minute was fat. Variables pain and fatigue before and after the intervention was recorded by the use of visual analogue scale at the time mentioned. The findings were analyzed by using the software SPSS version 17, descriptive and inferential statistics and tests of x^2 and Repeated measurments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109067494N1
Registration date:2012-05-30, 1391/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-30, 1391/03/10
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2011-09-08, 1390/06/17
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on pain, anxiety and fatigue in patients undergoing coronary artery bypass surgery
Public title
The effect of foot reflexology massage on pain, anxiety and fatigue in patients undergoing coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: first candidate for open heart surgery (CABG); under non- emergency heart- lung pump.
Exclusion criteria: lack of patient satisfaction on the ongoing research; lack of consciousness; the need to intra aorta pump; intubation of more than 24 hours; bleeding more than 200 cc per hour of chest tube; Performed surgery to repair or replace the valve with CABG; severe visual impairment; history of chronic pain; alcohol and drug addiction; drug addiction 4 hours before; having fractures; infected wounds and skin diseases in the left leg; severe disorders of hearing and visual; covered the sole of the left foot with dressing; remove the graft from the left foot and left sole are in the presence of any sensory impairment.
Age
From 40 years old to 78 years old
Gender
Both
Phase
2-3
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square. , Sari, mazandaran, Iran.
City
sari
Postal code
4816715793
Approval date
2011-09-07, 1390/06/16
Ethics committee reference number
90-88
Health conditions studied
1
Description of health condition studied
coronary artery by pass graft
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Pain after coronary artery bypass graft surgery
Timepoint
The second day, third, fourth and fifth after the surgery and immediately after each intervention.
Method of measurement
Visual Analog Scale
2
Description
Anxiety after coronary artery bypass graft surgery
Timepoint
The second day, third, fourth and fifth after the surgery and immediately after intervention
Method of measurement
Visual Analog scale
3
Description
Fatigue after coronary artery bypass graft surgery
Timepoint
The second day, third, fourth and fifth after the surgery and immediately after each intervention.
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Foot reflexology massage in the case group 20 minutes on the second, third, fourth and fifth after coronary artery bypass graft surgery
Category
Treatment - Other
2
Description
In the control group, only the left foot with fatty cream and researcher was present for 20 minutes on the second day, third, fourth and fifth postoperative coronary artery graft surgery on the patient's bedside
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh zahra hospital
Full name of responsible person
Masoumeh Bagheri Nesami
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, mazandaran, Iran.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Science
Full name of responsible person
Dr. Ahmahali Enayati
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square. , Sari, mazandaran, Iran.
City
Sari
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 Mazandaran University of Medical Science
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
4815696869
Phone
+98 11 3379 5555
Fax
Email
hedayat2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)