This study is a single blind randomized clinical trial that has been performed to determine the effectiveness of foot massage on intensity of physiological oedema of pregnancy. the study population comprised all pregnant women referred to urban health- therapeutic centers and prenatal clinic of Amiralmomenin hospital of Kordkuy affiliated to Golestan University of Medical Sciences. according to statistical calculations to estimate number of samples, 120 pregnant women eligible for the study, were enrolled to study by easy sampling and divided by randomized allocation to the intervention or control group(60 persons in each group). duration of study was 5 days. in the first day of the study, the intensity of physiological oedema of foot by pressing of pointing and middle fingers on tibial bone was determined and measuring 3-point of circumference of the both feet included circumference of the ankles, circumference of the heels and circumference of the joint of between the toes and metatarsal bones by non-elastic tape were measured in both groups. then in each sample of intervention group, foot massage has been performed for 10 min by researcher and this intervention has been performed by researcher for 3 consecutive days in the homes of samples and in the fifth day, intervention in experimental group and measurements for the both groups, has been performed in research environment and in order to achieve the research objective, intensity of physiological oedema of pregnancy, before and after the intervention was been compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012012198N1
Registration date:2013-03-08, 1391/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-08, 1391/12/18
Registrant information
Name
Mahdieh Kiani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3327 3594
Email address
kiani_m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-07-28, 1391/05/07
Expected recruitment end date
2012-11-10, 1391/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot massage on intensity of physiological edema of pregnancy
Public title
Effect of foot massage on physiological edema of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range 35-20 years; nulliparous pregnant; single pregnancy; pregnancy 30 weeks or more; oedema in the feet to leg and limited to +/++; not having gestational hypertension and preeclampsia, not having any known systemic disease such as heart disease, lung, kidney, diabetes, thrombophlebitis, hypertension and ... and known skin disease such as eczema, skin dermatitis and ... and any visible damage or other obstacle in the massage area, lack of exercise as a professional; not receiving a foot massage two days before the start of the study. Exclusion criteria: the presence of gestational hypertension and preeclampsia; sensitivity to baby oil; not having consent to continue participating in the study.
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran, Keshavarz blvd, edge of Qods street, central organization of University, Sixth floor
City
tehran
Postal code
Approval date
2012-07-17, 1391/04/27
Ethics committee reference number
765/ 130/د/91
Health conditions studied
1
Description of health condition studied
physiological oedema of pregnancy
ICD-10 code
o12.0
ICD-10 code description
Gestational oedema
Primary outcomes
1
Description
Intensity of physiological oedema of pregnancy
Timepoint
5 days after
Method of measurement
by pressing of pointing and middle fingers on tibial bone
2
Description
amount of physiological oedema of pregnancy
Timepoint
5 days after
Method of measurement
measure of circumference of the ankles, circumference of the heels and circumference of the joint between the toes and metatarsal bone by non-elastic tape
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the first day of the study, after completing the questionnaire and measuring the circumference of the ankles, circumference of the heels and circumference of the joint of between the toes and metatarsal bones, each foot massage has been performed for 10 min and for 3 consecutive days was performed in the homes of samples and in the fifth day, which is equal to the last day of the study,foot massage has been performed in research environment and measuring mentioned circumferences has been performed for feet.( all of the above steps was performed by researcher.).
Category
Other
2
Description
In the control group, the first day of the study, after completing the questionnaire; measuring the circumference of the ankles, circumference of the heels and circumference of the joint of between the toes and metatarsal bones has been performed by researcher and by non-elastic tape and during the study, there was no intervention, and in the fifth day, which is equal to the last day of the study; measuring mentioned circumferences has been performed by research assistant.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
urban health- therapeutic care center NO.1
Full name of responsible person
Maryam Joghataei
Street address
Kordkuy, Valiasr Street
City
Kordkuy
2
Recruitment center
Name of recruitment center
urban health- therapeutic care center NO.2
Full name of responsible person
Dr Nastaran Soleymani
Street address
Kordkuy, Jangal Street
City
Kordkuy
3
Recruitment center
Name of recruitment center
urban health- therapeutic care center( Former rural)
Full name of responsible person
Dr Ebrahim Mollaei
Street address
Kordkuy, Valaghuz
City
Kordkuy
4
Recruitment center
Name of recruitment center
Prenatal clinic of Amiralmomenin hospital
Full name of responsible person
Mohadeseh Kiani
Street address
kordkuy, Jangal street, Imam Ali square
City
kordkuy
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotuhi
Street address
Tehran, Keshavarz Blvd, edge of Qods Street, Central organization of University, Sixth Floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Kiani
Position
Master student of midwifery
Other areas of specialty/work
Street address
Tohid square, beginning of the Nosrat street, faculty of nursing and midwifery of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
kiani_m@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Rahimikian
Position
Msc of midwifery
Other areas of specialty/work
Street address
Tohid square, beginning of the Nosrat street, faculty of nursing and midwifery of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
f_rahimikian@yahoo.com
Web page address
http://www.tums.ac.ir/faculties/rahimikian
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Kiani
Position
Master student of midwifery
Other areas of specialty/work
Street address
Tohid square, beginning of the Nosrat street, faculty of nursing and midwifery of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
kiani_m@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)