A comparative study on the effects of a self-care educational program on the effleurage massage with foot immersion and raised legs on foot physiological edema during pregnancy.
To determine and compare the effect of self-care training with foot floss massage, hydrotherapy and raised legs on physiological edema of the foot in pregnant women
Design
A randomized controlled clinical trial and 140 samples that are collected in stages. First, the selection of treatment centers is purposeful and then the selection of intervention days is randomly collected from three different treatment centers separately. For each intervention group, a sample is collected from one medical center and for the control group, 12 samples are collected from each center.
Settings and conduct
This study in the field of complementary medicine will be performed with the aim of reviewing and comparing self-care training with massage therapy, hydrotherapy and keeping the legs high, which has three intervention groups and a control group. The sample size for each group is 35 people, for each of which The intervention groups will be collected from the medical center separately and for the control group in the form of 12 samples from each medical center. In order to randomize the intervention days, Excel software is used as a function of random numbers and the days of the week are randomly determined for each group, so that the samples of each group will be unaware of how other interventions are performed.
Participants/Inclusion and exclusion criteria
Primiparous pregnant women referred to Mahdieh, Arash and Akbarabadi medical centers in Tehran who are eligible for inclusion in the study
Intervention groups
massage therapy,hydrotherapy,raised legs,control
Main outcome variables
Degree of foot edema,circumferences of ankle jointe, inste and metatarsophalangeal joint
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220302054163N1
Registration date:2022-03-14, 1400/12/23
Registration timing:prospective
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Fatemeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6620 4258
Email address
fatmhasdy817@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of a self-care educational program on the effleurage massage with foot immersion and raised legs on foot physiological edema during pregnancy.
Public title
The effect of massage therapy, hydrotherapy and raised legs on foot edema in pregnancy by self-care method
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Pregnancy is primiparous
2. The age range is 20 to 35 years
3. Be a single pregnancy
4. Pregnancy is not the result of ART
5. The gestational age is between 30 and 40 weeks
6. Has physiological edema of the foot (in the range of +2 and more)
7. The mother does not have gestational hypertension and preeclampsia
8. The mother does not have any known systemic diseases (such as heart disease, kidney disease, lung disease, diabetes, chronic hypertension and thrombophlebitis).
9. The mother should not have rope varicose veins in the foot area.
10. No lesions are visible at the site of massage and hydrotherapy
Do not take drugs that affect foot edema, such as furozamide, hydrochlorothiazide, acetazolamide and triamterene.
Exclusion criteria:
1. The onset of gestational hypertension and preeclampsia
2. Reluctance to participate in the study and non-cooperation of the research sample at any time of the study
3. termination of pregnancy and preterm delivery for any reason
4. Failure to intervene in more than one case
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
the sample size for each of the intervention and control groups is staged. first, the choice of treatment centers, purposefully, and then the selection of intervention days are collected randomly from three different treatment centers separately. For each of the intervention groups, the sample size will be collected from a medical center and for the control group, 12 samples will be collected from each center.In the process of randomizing intervention days, Excel computer software, random numbers function will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Schools of Pharmacy, Nursing and Midwifery - Shahid Beheshti University
Street address
No.1, South Sajad jonoubi Ave, Khodayar hasani Ave, Chahardooli Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
1369636438
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.307
Health conditions studied
1
Description of health condition studied
Physiological pitting edema in pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Degree of foot edema
Timepoint
First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention
Method of measurement
the researcher places the index finger on the inner ankle of the specimen for 5 seconds and presses it if the indentation depth is greater than 2 mm to 4 mm and disappears in less than 15 seconds is second degree edema of the foot. If the depth of the depression is more than 4 mm to 7 mm and disappears in 15 to 30 seconds, edema of the foot is third degree. If the depth of the depression is more than 7 mm and it takes more than 30 seconds for it to disappear, the edema of the foot is grade 4.
2
Description
ankle joint circumference
Timepoint
First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention
Method of measurement
Inelastic meters
3
Description
instep circumference
Timepoint
First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention
Method of measurement
Inelastic meters
4
Description
metatarsophalangeal joint circumference
Timepoint
First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention
Method of measurement
Inelastic meters
Secondary outcomes
1
Description
ankle joint circumference
Timepoint
First time: on the first day of sample referral with the research environment - Second time: one day after the intervention
Method of measurement
Inelastic meters
2
Description
metatarsophalangeal joint circumference
Timepoint
First time: on the first day of sample referral with the research environment - Second time: one day after the intervention
Method of measurement
Inelastic meters
3
Description
instep circumference
Timepoint
First time: on the first day of sample referral with the research environment - Second time: one day after the intervention
Method of measurement
Inelastic meters
4
Description
age
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
Demographic Questionnaire
5
Description
Job
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
Demographic Questionnaire
6
Description
Education rate
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
Demographic Questionnaire
7
Description
Next visit time
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
questionnaire
8
Description
Gestational age
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
questionnaire
9
Description
Number of pregnancy visits
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
questionnaire
10
Description
walking
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
questionnaire
11
Description
Standing time during the day
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
questionnaire
12
Description
Add salt to the tablecloth
Timepoint
On the first day of sample referral to the research environment, before the intervention
Method of measurement
questionnaire
13
Description
Satisfaction with treatment
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
14
Description
Satisfaction with training
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
15
Description
Redness of the feet
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
16
Description
Inflammation of the foot
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
17
Description
leg pain
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
18
Description
Foot burning
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
19
Description
Itching in place
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
20
Description
Feeling of pain and discomfort in the uterus
Timepoint
The day after the intervention
Method of measurement
Complication and Satisfaction Questionnaire
21
Description
Edema of the foot joint
Timepoint
First time: on the first day of referring the sample to the research environment, second time: on the day after the intervention
Method of measurement
The researcher places the index finger above the inner ankle of the sample foot for 5 seconds and presses there if the indentation depth is more than 2 mm to 4 mm and disappears in less than 15 seconds. The depression is more than 4 mm to 7 mm and disappears within 15 to 30 seconds, the foot edema is third degree. If the depth of the depression is more than 7 mm and it takes more than 30 seconds to disappear, the foot edema is fourth degree. .
Intervention groups
1
Description
Intervention groups: self care with effleurage massage,self care with hydrotherapy,selfe care with raised legs
Shahid Arbabi St, Yasaman St next to Ayatollah Taleghani Hospital,Shahid Chamran High way, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Web page address
http://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tehran, Valiasr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Shahid Beheshti School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+098 21 88655356-7
Email
Msimbar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tehran, Valiasr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Shahid Beheshti School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 88655366-7
Email
Msimbar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tehran, Valiasr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Shahid Beheshti School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
0098 21 88655366-7
Email
Msimbar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data remain confidential to the researcher at the beginning of the study
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In connection with the study protocol, a diagram has been designed which will be completed and shared after the completion of the project. The informed consent form will be completed by the sample before the start of the research
When the data will become available and for how long
Available in the journal after publication
To whom data/document is available
All people who are interested in the article
Under which criteria data/document could be used
Promote complementary medicine and self-care treatments and treat physiological edema of the foot during pregnancy
From where data/document is obtainable
Email the responsible author
What processes are involved for a request to access data/document
Explain the reasons for requesting the article in the email