The effect of foot reflexotherapy on physiological Indexes and weaning time after open heart surgery in Baqiyattallah university of medical sciences hospitals
The purpose of this study is to investigate the effect of foot reflexology massage on the physiological indexes and weaning time in patients undergoing open heart surgery. This clinical trial will be conducted in three groups. 90 patients who are undergoing open heart surgery who have our study inclusion criteria will be randomly allocated into three groups: control, experimental and and placebo groups. after adequate explanations, written informed consent was obtained from patients. After transferring patients from to the intensive care unit, and the first hour time the foot reflexology massage was applied in experimental group patients in both legs in reflex points of heart and lung for 20 minutes. Vital signs were recorded in different times consist of ICU entrance, immediately after the first hour time,immediatly and10 minutes after intervention and during extubation and one hour after extubation. The time of the entrance patient until extubation will be recorded. There control group will receive the routine care. In placebo group after past one hour receive the massage in the heels of both legs for 20 minutes. Weaning time and vital signs are recorded and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401046778N3
Registration date:2014-04-24, 1393/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-24, 1393/02/04
Registrant information
Name
Seyed Tayeb Moradian Vafaei
Name of organization / entity
School of nursing and midwifery, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 4258
Email address
t-moradian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing faculty, Baghyattallah University of Medical Sciences
Expected recruitment start date
2014-02-28, 1392/12/09
Expected recruitment end date
2014-05-30, 1393/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexotherapy on physiological Indexes and weaning time after open heart surgery in Baqiyattallah university of medical sciences hospitals
Public title
The Effect of Foot Reflexotherapy on Physiological Indexes and Weaning Time
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with non-emergency cardiac surgery; age greater than 18 and less than 75 years; has a heart rate greater than 60 beats per minute; systolic blood pressure greater than 90 mm Hg; healthy legs
Exclusion criteria were: hemodynamic instability; delayed weaning process based on the physician's order; return to the operating room; dependance to the intra aortic balloon pump
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Science
Street address
Molla Sadra Ave, Vanak Square, Tehran
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
Meeting No. 34
Health conditions studied
1
Description of health condition studied
cardiac surgery
ICD-10 code
j95.1
ICD-10 code description
Acute pulmonary insufficiency following thoracic surgery
Primary outcomes
1
Description
Weaning Time
Timepoint
Since entering until extubation
Method of measurement
Using the Clock
2
Description
Physiological Indexes
Timepoint
Log since the first time at the reception immediately following the intervention, ten minutes after the intervention, during extubation, and an hour later
Method of measurement
Using Patient Monitoring
Secondary outcomes
1
Description
Reduce anxiety
Timepoint
Since entrance patient, the first hour, immediately and 10 minutes after massage and extubation and one hour after extubation
Method of measurement
FAS criteria
Intervention groups
1
Description
intervention groups , Foot reflexology in this case,The first step should be holding foot for a minute. Secondly, for each foot perform foot spread for a minute. In the third stage, the four fingers of both hands on the dorsal surface of the foot (the left foot, then right foot) has been given the thumbs on the hands (the Ball every foot reflexology areas of the heart and lungs are in this area) rotating basis 7-10 minutes and with gentle pressure massage will. And the final step will take a minute Top sliding. Overall, both legs will massage for 20 minutes.
Category
Other
2
Description
Placebo treatment group after the first hour, the soles of both feet will touch the surface. A total duration of 20 minutes for both legs (each leg separately, 10 minutes) will be.
Category
Other
3
Description
The control group received no intervention and usual care patients will be monitored.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
jamaran Heart Hospital
Full name of responsible person
Street address
Jamaran Heart hospital, Jamaran st, Niavaran St, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Hospital Baqiyatallah
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing - University of Medical Sciences ... (Aj)
Full name of responsible person
doctor Abbas Ebadi
Street address
Tehran, Sadra St., St. Sheikh Bahai University of Medical Sciences ... (Aj)
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing - University of Medical Sciences ... (Aj)
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
Nursing Faculty, Baghiyyatallah university of medical sciences
Full name of responsible person
Seyed Tayeb Moradian
Position
Faculty member
Other areas of specialty/work
Street address
Tehran, Sadra St., St. Sheikh Bahai University of Medical Sciences ... (Aj)
City
Tehran
Postal code
Phone
00
Fax
Email
t-moradian@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing faculty, Baghiyatallah University of medical sciences
Full name of responsible person
Dr Abbas Ebbadi
Position
The faculty Member
Other areas of specialty/work
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehra
City
Tehran
Postal code
Phone
+98 21 2228 6057
Fax
Email
ebadi1347@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)