Compare the effect of early ambulation and gradually ambulation with exercise in bed on hemodynamic factors and complication of sleeve gasterectomy operation
Objective: Compare the effect of early ambulation and gradually ambulation with exercise in bed on hemodynamic factors and complication of sleeve gasterectomy operation. Study population: patients undergoing sleeve gastrectomy, has a medical record in the Shiraz Ghadir Mother and child sub_specialized hospital. Inclusion and exclusion criteria: body mass index over 30 main criteria inclusion and main exclusion criteria complication during surgery. Sample size: 44 people early ambulation group (Group 1); 44 gradually ambulation with exercise in bed (Group 2); 44 patients in the control group (Group 3) were allocated.primary outcome variables: Pain, Vomiting, Arterial oxygen saturation ,Blood pressure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051527904N1
Registration date:2016-06-22, 1395/04/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-22, 1395/04/02
Registrant information
Name
Mohammad Reza Koohpeyma
Name of organization / entity
Yasuj
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7251
Email address
mohamadreza.koohpaima@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Yasuj University of Medical Sciences
Expected recruitment start date
2016-05-15, 1395/02/26
Expected recruitment end date
2016-08-16, 1395/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of early ambulation and gradually ambulation with exercise in bed on hemodynamic factors and complication of sleeve gasterectomy operation
Public title
Compare the effect of early ambulation and gradually ambulation with exercise in bed, on complication of operation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in the study; Age between 18 and 55 years; Don't have history of respiratory disease; Don't have history of mental disorders; Don't use to addict to opioid and cigarettes; Have literacy; Body mass index was between BMI≥30, BMI≤55.
Exclusion criteria:
Discontinue to participate in the study; Muscloskeletal pain due to positioning during surgery; Intolerance intervention protocol; Abnormal complication during surgery: including damage to blood vessels, removing excess stomach and ...; In the event that leaks occur after stomach surgery incision.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation block
Secondary Ids
1
Registry name
_
Secondary trial Id
_
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Iran, Yasuj, motahari martyr BLVD, Yasuj University of Medical Science, office of research and technology
City
Yasuj
Postal code
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.YUMS.REC.1395.30
Health conditions studied
1
Description of health condition studied
sleeve gasterectomy
ICD-10 code
_
ICD-10 code description
_
Primary outcomes
1
Description
pain
Timepoint
Before the operation, after enterance to the ward , after the first intervention, 6 hours after the intervention , 12 hours after the intervention , 24 hours after intervention
Method of measurement
base on V.A.S scale
2
Description
vomiting
Timepoint
Before the operation, after enterance to the ward , after the first intervention, 6 hours after the intervention , 12 hours after the intervention , 24 hours after intervention
Method of measurement
Based on the frequency and patient interview
3
Description
oxygen saturation
Timepoint
Before the operation, after enterance to the ward , after the first intervention, 6 hours after the intervention , 12 hours after the intervention , 24 hours after intervention
Method of measurement
pulse oxymeter
4
Description
blood pressure
Timepoint
Before the operation, after enterance to the ward , after the first intervention, 6 hours after the intervention , 12 hours after the intervention , 24 hours after intervention
Method of measurement
blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
early ambulation
Category
Rehabilitation
2
Description
intervention group 2: gradually ambulation with exercise in bed
Category
Rehabilitation
3
Description
control group: Out of bed based on routine in ward
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Reza Koohpeyma
Street address
Shiraz-ghadir Mother and child subspecialized hospital
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Office of research of Yasuj University of Medical Science
Full name of responsible person
Dr. Akbartabar mehdi
Street address
Iran, Yasuj, motahari martyr BLVD, Yasuj University of Medcal Science, office of research of Yasuj University of Medical Science
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Office of research of Yasuj 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
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Sayed Javad sadat
Position
MSc medical surgical nursing
Other areas of specialty/work
Street address
Iran, Yasuj, Dr jalil avenue, faculty of nursing-midwifery
City
Yasuj
Postal code
Phone
+7 433235141
Fax
Email
sadatsaiedjavad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Sayed Javad Sadat
Position
MSc medical surgical nursing
Other areas of specialty/work
Street address
Iran, Yasuj, Yasuj University of Medical Science
City
Yasuj
Postal code
Phone
+7 433235141
Fax
Email
sadatsaiedjavad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Mohammad Reza Koohpeyma
Position
MSc medical surgical nursing
Other areas of specialty/work
Street address
Yasuj University of Medical Science
City
Yasuj
Postal code
7144995377
Phone
+7 433235141
Fax
+7 433337251
Email
mohamadreza.koohpaima@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)