The main purpose: to determine the effect of breast oketani massage on breast engorgement and neonate weight gain.Randomized Clinical Trialclinical trial people accidentally block that blocks normal delivery or cesarean, In this study fall into two groups.Before starting to work, the general temperature mercury thermometer under the tongue is controlled manner. Inventory demographic, obstetric and breast-feeding has been completed for each person measuring the severity of breast engorgement, according to the Czech list of breast engogement score, performed and recorded by the researcher. Interventions in breast congestion control group consisted of routine actions (including proper breastfeeding techniques, breast massage and spa shower.) And interventions in the intervention group: breast oketani massage for 30 minutes once per left and right breasts done. Massage for 2 days continue .first and second days before and after the intervention Breast engogenent is recorded and weight at the beginning of the study and day 14 and 28 postpartum in both intervention and control groups done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062728669N1
Registration date:2016-09-08, 1395/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-08, 1395/06/18
Registrant information
Name
Mahsa Dehghani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5733 2534
Email address
dehghanik921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breast oketani massage on breast engorgement and neonate weight gain
Public title
The effect of breast oketani massage on breast engorgement and neonate weight gain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteri؛ having a desire to participate in the study;To participate in the study have written consentThe risk of breast engorgement in 5 days after delivery, a minimum score of 2 out of 19 breast congestion score based on the severity of the Czech list;Do not use medication that suppresses lactation, lack of mastitis (according to the gynecologist) Mother temperature lower than 38 ° C, without any restriction Breastfeeding is breastfeeding and continued breastfeeding is going, having Breastfeeding every 2-3 hours; gestational age at delivery is complete between 37 to 42 weeks, singleton pregnancy have infants, children age one to five days, based on the scale of breast congestion, congestion score at least two of each breast is no history of breast surgery ; lack of high-risk pregnancy and childbirth, normal weight, healthy full-term singleton birth (4000-2500 g), having a power-sucking; no ban on feeding such as prematurity, risk of cleft lip and palate and ...
Exclusion criteria ; not wanting to continue collaborating in the study; increase temperatures at the mother to more than 38 ° C after intervention; use or need for any anti-inflammatory drug during the intervention; once intervention; the interval massage octane breast up to 48 hours; during the course of treatment to mastitis or breast abscesses; the occurrence of certain problems for the neonate such as ; fever; neonate hospitalized or separation from mother occur for any reason.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
University Ave.
City
Mashhad
Postal code
13944-91388
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.MUMS.REC.1395.156
Health conditions studied
1
Description of health condition studied
Breast engoregment
ICD-10 code
O92.7
ICD-10 code description
Other and unspecified disorders of lactation
Primary outcomes
1
Description
The severity of breast engorgement
Timepoint
The first day, before and after intervention. The second day after intervention
Method of measurement
Breast congestion lis
Secondary outcomes
1
Description
neonate weight gain
Timepoint
Beginning of the study. Day 14 Day 28 after birth
Method of measurement
Balance
Intervention groups
1
Description
Interventions in breast congestion control group consisted of routine actions (including proper breastfeeding techniques, breast massage and spa shower ..)
Category
Other
2
Description
Interventions in the intervention group: the routine for breast engorgment, breast-oketani massage for 30 minutes with a right and left turns in both breasts done. Massage for 2 days continue to be heavily engorgment due to the Czech list of the engorgment breast first and second days before and after the intervention and weight at the beginning of the study and day 14 and 28 postpartum in both intervention and control groups done. oketani massage on two occasions, the first day and the second day is by Researcher
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center Najafi
Full name of responsible person
Dehghani
Street address
Victory Blvd.
City
Mashhad
2
Recruitment center
Name of recruitment center
Health Center silo
Full name of responsible person
Dehghani
Street address
Victory Blvd.
City
Mashhad
3
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dehghani
Street address
Ibn Sina Street
City
Mashhad
4
Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Dehghani
Street address
Azadi Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ms. Mahmoudi
Street address
University Ave.
City
Mashhad
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
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
Mashhad University of Medical Sciences
Full name of responsible person
MAHSA DEHGHANI
Position
Midwife
Other areas of specialty/work
Street address
No 21, sarafrazan40 Alley, sarafrazan St
City
Mashhad
Postal code
Phone
+98 51 3868 6458
Fax
Email
Dehghanik921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.R.BABAZADEH
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
No 21, University St, Shariati Sq
City
Mashhad
Postal code
Phone
+98 51 3859 1512
Fax
Email
Babazadehr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
MAHSA DEHGHANI
Position
Midwife
Other areas of specialty/work
Street address
No 21, sarafrazan40 Alley, sarafrazan St
City
Mashhad
Postal code
Phone
00
Fax
Email
Dehghanik9212mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)