Investigating the effect of self-care training on the management of peripheral lower extremity edema in late pregnancy
Design
In this clinical trial, a control group with unblinded parallel groups will be conducted with phase 2 simple randomization on 60 pregnant women in Tehran. 30 pregnant women will be placed in the intervention group and 30 pregnant women in the control group by simple random method. Random Number Generator will be used for randomization
Settings and conduct
This clinical trial will involve 60 pregnant women at Ayatollah Kashani Hospital, with 30 in the intervention group and 30 in the control group. The intervention group will receive an educational booklet on managing lower limb swelling during pregnancy. Both groups will receive routine care, and the severity of lower limb edema will be assessed before and after the intervention at 5,10 and 30-day intervals.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The women aged between 18 and 35 Normal pregnancy (without complications) between 30 and 34weeks 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; No bed rest required; Absence of mental problems; Not taking medicine except supplements during pregnancy; No drug addiction
Intervention groups
In the intervention group, 30 pregnant women at 30-34 weeks with leg edema received face-to-face training in addition to routine pregnancy care. The training included a two-hour session on using a self-care training booklet and educational slides in a private environment. The control group (30 pregnant women at 30-34 weeks with leg edema) received usual pregnancy care.
Main outcome variables
Severity of lower limb peripheral edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240407061436N1
Registration date:2024-07-18, 1403/04/28
Registration timing:prospective
Last update:2024-07-18, 1403/04/28
Update count:0
Registration date
2024-07-18, 1403/04/28
Registrant information
Name
Negin Mahmoudi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 7794 3267
Email address
n_mahmoudi@modares.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2025-07-22, 1404/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care training on the management of peripheral edema of the lower limbs during late pregnancy
Public title
The effect of selfcare on management of leg edema during late pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 35
Normal pregnancy (without complications) between 30 and 34weeks 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
No bed rest required.
Absence of mental problems
Not taking medicine except supplements during pregnancy
No drug addiction
Exclusion criteria:
Performing other exercises or other specific treatment to remove leg edema during the study (according to the patient's statement)
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
participate in other training classes
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
Jalal Ale Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.MODARES.REC.1403.001
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
5 and 10 and 30 days 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
"Intervention group:" In this project, the intervention group includes 30 30pregnant women with lower limb edema, 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 management of lower limb edema 6. Teaching methods of preventing lower limb edema during pregnancy 7. Teaching the effect of a healthy lifestyle on the management 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 includes 30 pregnant women with lower limb edema, will receive usual prenatal care
Is the source of funding the same sponsor organization/entity?
No
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
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad, before the Nasr underpass
City
Tehran
Province
Tehran
Postal code
1411713116
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
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad, before the Nasr underpass
City
Tehran
Province
Tehran
Postal code
1411713116
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
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad, before the Nasr underpass
City
Tehran
Province
Tehran
Postal code
1411713116
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
Yes - There is 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