Evaluating the effect of self-care education on prevention of peripheral lower extremities' edema during pregnancy
Design
This controled clinical trial, with unblinded parallel groups with simple randomization phase 2 on 60 pregnant women in Chegani city of Lorestan province. 30 pregnant women will in the intervention group and 30 pregnant women will be in the control group with simple randomization method.
Settings and conduct
In a clinical trial conducted in health centers of Chegani, Lorestan, 60 pregnant women will participate. Participants will be divided into an intervention group (n=30) and a control group (n=30). The intervention group will receive an educational booklet on preventing and managing lower limb edema during pregnancy. Additionally, a two-hour training session with a slide presentation will explain how to use the booklet. Standard prenatal care will continue for both groups. The severity of lower limb peripheral edema in pregnant women will be assessed at various time points: preintervention (27-28 weeks’ gestation), immediately postintervention, and one and two months postintervention in both groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- First pregnancy and singleton, Age between 18 and 35, Normal pregnancy (without complications) between 27 and 28 weeks. Absence of edema in legs and feet, BMI in the normal range, The normal amniotic fluid
Exclusion criteria
history of infertility,suffering from any disease
Intervention groups
The intervention group consists of 30 pregnant women who will receive routine pregnancy care along with a face-to-face training session. That they learn how to read the self-care training booklet, and educational slides are presented for two hours in a private setting. In contrast, the control group (n=30) will receive only routine pregnancy care.
Main outcome variables
Severity of lower limb peripheral edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240128060830N1
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Niloofar Fooladi
Name of organization / entity
Tarbiat modares
Country
Iran (Islamic Republic of)
Phone
+98 66 3326 2473
Email address
n.fooladi@modares.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on prevention of peripheral lower extremities edema during pregnancy
Public title
The effect of self-care education on prevention of peripheral lower extremities edema during pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy and singleton
Age between 18 and 35
Normal pregnancy (without complications) between 27 and 28 weeks of pregnancy
Absence of edema in legs and feet
BMI in the normal range (normal BMI is 19.8 to 24 kg/m2)
The normal state of amniotic fluid
No history of infertility
Not suffering from any disease (according to the patient's records and statements)
No bed rest required.
Absence of mental problems (according to the file)
Not taking medicine except supplements during pregnancy (according to the file and the patient's statement)
No drug addiction (according to the patient's case and statement)
Exclusion criteria:
Performing other exercises or other specific treatment to remove leg edema during the study (according to the patient's statement)
Reluctance to exercise
Standing for a long time or having a job condition of sitting and standing for a long time
The occurrence of problems such as fractures in the lower limbs
Reluctance to complete the measurement
participate in other training classes
Failure to fully complete the checklist
Receiving medicine or a special diet to relieve pain and edema during study
Suffering from pre-eclampsia or eclampsia during the intervention process
Receiving other complementary medicine methods
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be placed in two control and intervention groups in a simple random manner using a table of random numbers.
Randomization method: simple randomization
random sequence: using Random Number Generator for random sequence generation
people enter the sequence: The numbers created by the Random Number Generator will be placed in a sealed envelope, and the person will be placed in the intervention or control group by choosing each envelope.
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
National system of ethics in biology research
Street address
Quds settlement (west) - between South Flamak and Zarafshan, Simai Iran St. - Ministry of Health, Treatment and Medical Education headquarters, block A, 13th floor
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2024-04-19, 1403/01/31
Ethics committee reference number
IR.MODARES.REC.1403.002
Health conditions studied
1
Description of health condition studied
Edema of the lower limbs during pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean peripheral edema severity scores
Timepoint
immediately and one month and two months after the intervention
Method of measurement
In the present study, the measurement of the circumference around the wrist, around the heel and around the joint between the fingers and metatarsal bones of the MPJ will be used to check the amount of edema using an inflexible tape measure.
Secondary outcomes
empty
Intervention groups
1
Description
In this project, the intervention group including 30 pregnant women, in addition to routine pregnancy care, a face-to-face training session will be held in the form of training to justify the samples on how to read the self-care training booklet along with the presentation of educational slides for two hours individually in a quiet private environment. . If necessary, the meeting will be repeated. Educational items include the following: 1. Getting to know the concept of edema during pregnancy 2. Knowing the factors affecting lower limb edema and its evaluation methods 3. Knowing the difference between normal and abnormal edema 4. Danger signs 5. Familiarity with the concept of self-care and prevention of lower limb edema 6. Teaching methods of preventing lower limb edema during pregnancy 7. Teaching the effect of a healthy lifestyle on the prevention of lower limb edema (active) Staying, correct weight during pregnancy, adequate hydration, proper nutrition during pregnancy) 8. Exercises and stretches that increase blood flow and reduce edema 9. Choosing the right shoes to wear 10. Teaching massage therapy and foot care to increase blood flow 11. Teaching massage by the person himself 12. Teaching Hydrotherapy 13. Familiarity with elastic medical socks 14. Medical and therapeutic measures in the face of pregnancy edema and psychological and emotional effects of edema during pregnancy and teaching anxiety reduction strategies
Category
Lifestyle
2
Description
Control group: The control group will receive routine pregnancy care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive rural health service centers of Chegani city, Lorestan province
Full name of responsible person
Farkhondeh Amin Shokravi
Street address
Comprehensive rural health service centers of Chegani city, Lorestan province
City
Chegeni
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Farkhondeh Amin Shokravi
Street address
jalal al ahmad
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 4506
Email
aminsh_f@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares university
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
Tarbiat modares university
Full name of responsible person
Farkhondeh Amin Shokravi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal al ahmad
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 4506
Email
aminsh_f@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Farkhondeh Amin Shokravi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal al ahmad
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 4506
Email
aminsh_f@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Farkhondeh Amin Shokravi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal al ahmad
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 4506
Email
aminsh_f@modares.ac.ir
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
There will be data on the effects of self-care training on the amount of edema during pregnancy
When the data will become available and for how long
After the articles are published
To whom data/document is available
Research stakeholders and participating organizations in research
Under which criteria data/document could be used
The necessary conditions for submitting a request for access to data or documents are only available if a national plan is carried out, or a guideline is developed, or a meta-analysis is performed through a request to the responsible researcher.
From where data/document is obtainable
Farkhondeh Amin Shokravi aminsh_f@modares.ac.ir
What processes are involved for a request to access data/document
Written request to the person in charge of the data, referral to the research assistant of the faculty and university, and in case of agreement to transfer the data