Determining effect of early ambulation on post cesarean delivery pain and quality of recovery
Design
The clinical trial has two control and intervention groups, double blind, Choice as available and division by permutation blocks and on 134 patients.
Settings and conduct
After coordinating with the supervisor of the surgery section of Mobini Sabzevar Hospital, collecting data in the surgery section shall be conducted .
First, the patients after cesarean section are selected, based on entry criteria; Then the patients are divided into two groups that A will be placed in the intervention group which is the early ambulation method, then B will be placed in the control group which was the normal method of the department; C will be placed in the control group and D in the intervention group, and they will be placed in the control and intervention groups, respectively.
Participants/Inclusion and exclusion criteria
Entry criteria: post cesarean delivery patients; gestational age of 37 to 40 weeks; informed consent to participate in the study; sufficient consciousness to determine the intensity of pain; stable vital signs.
Not-entry criteria: smoking and drug addiction; alcohol addiction; difficult pregnancy; having movement disorders or defects in the lower limbs; having a clear mental disorder and severe mood-emotional disorder that prevents effective communication; suffering from chronic diseases such as liver problems and immune system deficiency; lumbar disc disease; performing cesarean section after failure of natural delivery; extreme malnutrition with BMI less than 18.5.
Intervention groups
Intervention group: ambulation with a time interval of 4 hours after the operation and at a distance of 5 meters if the patient can tolerate it. Control group: ambulation of patient normally, 8 hours after cesarean section.
Main outcome variables
Reduced pain; increased quality of recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240509061715N1
Registration date:2024-06-05, 1403/03/16
Registration timing:prospective
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Maryam Mohammadiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 4946
Email address
mryam.mh76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of early ambulation on post cesarean delivery pain and quality of recovery in the Mobini Sabzevar Hospital in 2024-2025
Public title
The effect of early ambulation on post cesarean delivery pain and quality of recovery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post cesarean delivery patients
Gestational age of 37 to 40 weeks
Informed consent to participate in the study
Sufficient consciousness to determine the intensity of pain
Stable vital signs
Exclusion criteria:
Smoking and drug addiction
Alcohol addiction
Difficult pregnancy
Having movement disorders or defects in the lower limbs
Having a clear mental disorder and severe mood-emotional disorder that prevents effective communication
Suffering from chronic diseases such as liver problems and immune system deficiency
Lumbar disc disease
Performing cesarean section after failure of natural delivery
Extreme malnutrition with BMI less than 18.5
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Not informing the outcome evaluator about the patient's membership in the control or intervention group
Not informing the data analyst about the patient's membership in the control or intervention group
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar ,Nuclear Martyrs Blvd ,Ethics commitee of Sabzevar University of Medical Sciences.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2024-04-17, 1403/01/29
Ethics committee reference number
IR.MEDSAB.REC.1403.002
Health conditions studied
1
Description of health condition studied
Cesarean delivery
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Before and immediately after the intervention, 12, and 18 hours after the operation
Method of measurement
Numerical rating pain scale
Secondary outcomes
1
Description
Quality of recovery
Timepoint
24 and 48 hours after the operation
Method of measurement
QOR15 scale
Intervention groups
1
Description
Intervention group: Early ambulation after cesarean surgery with an interval of 4 hours after surgery
Category
Treatment - Other
2
Description
Control group: Ambulation after cesarean surgery with an interval of 8 hours after surgery, as routine of the department
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobini Sabzevar Hospital
Full name of responsible person
Hasan Khalili
Street address
Hospital Mobini, Kashefi Ave.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613856799
Phone
+98 51 4423 8100
Email
mh.lib@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hasan pour
Street address
Sabzevar, Nuclear Martyrs Blv, Sabzevar University Of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Email
drhassanpour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hasan Khalili
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sabzevar, Davarzani 4 Ave, No 4
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619614684
Phone
+98 51 4464 2383
Email
khalili894@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam Mohammadiani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sabzevar, Nuclear Martyrs Blvd, Sabzevar University of Medical Sciences.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619614493
Phone
+98 51 4422 4946
Email
mryam.mh76@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam Mohammadiani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sabzevar, Nuclear Martyrs Blvd, Sabzevar University of Medical Sciences.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619614493
Phone
+98 51 4422 4946
Email
mryam.mh76@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Coordination with the relevant instructor in this regard has not been done yet.
When the data will become available and for how long
Coordination with the relevant instructor in this regard has not been done yet.
To whom data/document is available
Coordination with the relevant instructor in this regard has not been done yet.
Under which criteria data/document could be used
Coordination with the relevant instructor in this regard has not been done yet.
From where data/document is obtainable
Coordination with the relevant instructor in this regard has not been done yet.
What processes are involved for a request to access data/document
Coordination with the relevant instructor in this regard has not been done yet.