To determine the effect of Ginger compress on breast engorgement in Lactating Women
Design
Randomized Clinical Trial study was conducted on 76 eligible lactating women who were admitted to the study that people accidentally block that blocks normal delivery or cesarean, In this study fall into two groups
Settings and conduct
The intervention is performed three times a day for two days on the breast (right or left or both) done. Breast engorgement is recorded before and 12 to 24 hours after the end of the interventions according to the checklist for breast engorgement score.Blind was not possible due to the scent of ginger.
Participants/Inclusion and exclusion criteria
Inclusion and Exclusion criteria؛ Iranian and resident of Mashhad , Having a desire to participate in the study, Have at least reading and writing skills;Has a baby for 2 to 5 days after delivery ,a minimum score of 2 out of 19 breast congestion score based on the severity of the Czech list; Pain score based on the visual scale of pain more than 2 ,lack of mastitis, lack of high-risk pregnancy and childbirth, Sensitivity to ginger during use, Accident and stressful events during the study, the occurrence of certain problems for the neonate
Intervention groups
Interventions in breast congestion control group consisted of routine actions (including proper breastfeeding techniques and hot compress..) Interventions in the intervention group:the routine for breast engorgement, ginger compress for 30 minutes Three times a day for two days on the breast (right or left or both) done. before and after the intervention Breast engorgement is recorded according to the checklist for breast engorgement score.the first treatment is by Researcher
Main outcome variables
The severity of breast engorgement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180508039585N1
Registration date:2018-05-15, 1397/02/25
Registration timing:registered_while_recruiting
Last update:2018-05-15, 1397/02/25
Update count:0
Registration date
2018-05-15, 1397/02/25
Registrant information
Name
maryam monazami vazifehdost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 0193
Email address
monazzamivm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-13, 1397/02/23
Expected recruitment end date
2018-08-14, 1397/05/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginger compress on breast engorgement in Lactating Women
Public title
The effect of Ginger compress on breast engorgement in Lactating Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of Mashhad
Having a desire to participate in the study
Have at least reading and writing skills
Having a phone to access the person
Gestational age at delivery is complete between 37 to 42 weeks
Healthy full-term singleton birth (4000-2500 g)
It is breastfeeding and intends to continue lactation
Exclusive breastfeeding pattern
The risk of breast engorgement in 2 to 5 days after delivery
Not having a history of or current illness
lack of high-risk pregnancy and childbirth
No history of breast surgery
Mother temperature lower than 38 ° C
A minimum score of 2 out of 19 breast congestion score based on the severity of the Czech list
Pain score based on the visual scale of pain more than 2
Do not use medication that suppresses lactation
Non-use of topical herbal remedies in the breast
lack of mastitis (according to the gynecologist)
Having certain problems for the neonate that leads to impairment in breastfeeding
Exclusion criteria:
Increase temperatures at the mother to more than 38 ° C after intervention
Breastfeeding intervals greater than 3 hours
Not wanting to continue collaborating in the study
Take less than 5 treatment interventions
The treatment interval is less than 6 hours and more than 8 hours
During the course of treatment to mastitis or breast abscesses
Lack of access to the participant 12 to 24 hours after the intervention
Sensitivity to ginger during use
Accident and stressful events during the study
The occurrence of certain problems for the neonate that lead to impairment in breastfeeding.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized Clinical Trial clinical trial people accidentally block that blocks normal delivery or cesarean, In this study fall into two groups.This method will be done using the PASS (Power Analysis and Sample Size ) software
Before and 12 to 24 hours after the end of the interventions
Method of measurement
Breast congestion list
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Interventions in breast congestion control group consisted of routine actions (including proper breastfeeding techniques and hot compress..)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Dr.abdollah bahrami
Street address
Enesina Ave, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Bahramia@mums.ac.ir
2
Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Dr.Ali Mehri
Street address
Ahmad Abad Ave,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91199-91766
Email
MehriA1@mums.ac.ir
3
Recruitment center
Name of recruitment center
Omolbanin hospital
Full name of responsible person
Dr Fateme Tara
Street address
16, Bahgat Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Email
taraf@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Qureishi bulding, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Monazami vazifeh dost
Position
Master of science student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 4, Honarestan 16 Ave, Vakil abad Blvd , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91786-58411
Phone
+98 51 3881 0193
Email
monazzamivm951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Yousefzadeh
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebne Sina Street, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
yousefzades@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Monazami vazifehdost
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahar Ave., Medical Army Hospital., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
91786-58411
Phone
+98 51 3881 0193
Fax
Email
monazzamivm951@mums.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available