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The effect of Oketani massage on volume milk and breastfeeding behavior in premature infants admitted to neonatal intensive care unit

Protocol summary

Study aim
The aim of this study was to determine the effect of Oketani massage on volume milk and breastfeeding behavior in premature infants admitted to neonatal intensive care unit
Design
The quasi-experimental has control group, parallel group and non-randomized groups.
Settings and conduct
Oketani massage during first 6 hours after delivery for the intervention group for 20 minutes in the morning and evening for 3 consecutive days will be performed by the researcher in the rest room of the neonatal ward of Imam Reza and Ghaem hospitals. Data analysts and sample allocators to groups are not aware of the allocation of samples.
Participants/Inclusion and exclusion criteria
Entry Criteria: The age of the mother is between 20 and 35 years Be literate and be able to understand writing and verbal instructions The mother tends to breastfeed No entry Criteria: The mother has a history of serious and chronic illness such as cardiovascular disease or mental illness (postpartum depression, schizophrenia) according to the mother. The mother is addicted to drugs, especially cocaine and derivatives, according to the mother. The mother take medications that are contraindicated during breastfeeding, such as doxepin tricyclic antidepressants, iodine compounds, gold salts, salicylates, and anticonvulsants during the intervention. The mother has a history of breast surgery and no history of injuries or wounds at the massage site and no breast problems (breast fissures, congestion, mastitis and breast abscess). The mother take lactation-enhancing drugs, including metoclopramide.
Intervention groups
Intervention group: Oketani massage will be performed in three days after delivery, 6 hours after delivery (for 20 minutes in each session in the morning and evening) in the mothers' rest room. Control group: There is no intervention in this group.
Main outcome variables
Milk volume and breastfeeding behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201108049304N1
Registration date: 2020-12-17, 1399/09/27
Registration timing: prospective

Last update: 2020-12-17, 1399/09/27
Update count: 0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Fatemeh Rezaei shoja
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3732 3236
Email address
rezaeisf971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Oketani massage on volume milk and breastfeeding behavior in premature infants admitted to neonatal intensive care unit
Public title
The effect of Oketani massage on breastfeeding
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the mother is between at least 20 and at most 35 years Be literate and be able to understand writing and verbal instructions The mother tends to breastfeed
Exclusion criteria:
The mother has a history of serious and chronic illness such as cardiovascular disease or mental illness (postpartum depression, schizophrenia) according to the mother. The mother is addicted to drugs, especially cocaine and derivatives, according to the mother. The mother take medications that are contraindicated during breastfeeding, such as doxepin tricyclic antidepressants, iodine compounds, gold salts, salicylates, and anticonvulsants during the intervention. The mother has a history of breast surgery and no history of injuries or wounds at the massage site and no breast problems (breast fissures, congestion, mastitis and breast abscess). The mother take lactation-enhancing drugs, including metoclopramide.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data analysts and sample allocators to groups are not aware of the allocation of samples in each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
The central building of Mashhad University of Medical Sciences, Daneshgah St., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.058

Health conditions studied

1

Description of health condition studied
Fetus and newborn affected by other maternal noxious substances
ICD-10 code
P04.8
ICD-10 code description
Newborn (suspected to be) affected by other maternal noxious substances

Primary outcomes

1

Description
The volume of mothers' breast milk
Timepoint
In the first to third days after delivery, half an hour before and after the intervention in the morning and evening
Method of measurement
Electric milking machine

2

Description
Breastfeeding behavior
Timepoint
Once in the first three days and once on the day of discharge and once at the end of the neonatal period (28 days) at the time of the mother's visit to examine the newborn
Method of measurement
PIBBS Breastfeeding Behavior Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oketani massage will be performed in three days after delivery, 6 hours after delivery (for 20 minutes in each session in the morning and evening) in the mothers' rest room. Oketani massage for the intervention group includes breast massage which includes a total of 8 hand techniques. Stage 1-7 is called a course of treatment, this step is done in 1 minute and repeated for 15-20 minutes. Step 1 Pressing and lifting the breast by the third finger of the right hand and the little finger of the left hand to the left shoulder, Step 2 Pressing and lifting the central part by the third finger of both hands to the armpit, Step 3 Pressing and lifting the breast by the third finger and sixty hands Right and third finger of the left hand and placing the thumb above the second joint of the thumb of the right hand, here pressing and pulling parallel to the opposite breast, these steps 1, 2 and 3 are to separate the firm part of the breast from the pectoralis major muscle, step 4 pressing the whole breast towards Umbilical cord, step 5 pulling the breast down to the right, step 6 pulling the breast down to the left, step 7 Turn the breast gently clockwise and pay attention to the elasticity of the breast base, step 8 milking the breast in four directions upwards.
Category
Other

2

Description
Control group: There is no intervention in this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mostafa Dastani
Street address
Ghaem Educational, Research and Treatment Center, Ahmadabad St., Dr. Shariati Square (Taghiabad), Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91871-45785
Phone
+98 51 3840 0000
Email
ghaem.hos@mums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ali Khorsand
Street address
Ebne Sina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13316
Phone
+98 51 3854 3031
Email
imam.reza.hospital@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
The central building of Mashhad University of Medical Sciences, Daneshgah St., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
presidentoffice@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
Tahere Sadeghi
Position
Assistant Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashhad University of Medical Sciences, Daneshgah St., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
sadeghit@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahere Sadeghi
Position
Assistant Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashhad University of Medical Sciences, Daneshgah St., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
sadeghit@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei shoja
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.16,Sidi.4,Bilal.5,lmam Hossein Square,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3732 3236
Fax
Email
Rezaeisf971@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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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