Determining the effect of yoga on the volume and composition of breast milk in premature infants admitted to the neonatal intensive care unit
Design
Random Allocation Software was used for randomized clinical trial with functional groups with functional groups, blind one-way, randomized, on 78 mothers.
Settings and conduct
In the control group, after routine breastfeeding training, sampling is done by a trained researcher. For all mothers in the control group, sampling is done on the first and sixth day.
In the second group (yoga), in addition to routine breastfeeding training, mothers are taught yoga relaxation techniques by a yoga specialist from the first day of study to the sixth day in the presence of a researcher in a quiet room separate from the neonatal ward.
The duration of yoga intervention is 45 minutes every day for 6 consecutive days after routine breastfeeding training. For all mothers in the intervention group on the first and sixth days after the end of the class, milk samples are collected and measured through an electric milk pump and 5 ml of milked breast milk is stored at -80 degrees in the University Research Center. Blinding has been done on a laboratory evaluator and an analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Be primiparous; Intrauterine age below 34 weeks;Mothers who spend 4-6 days after giving birth
Exclusion criteria:Multiplication
Intervention groups
The study is done in two groups. In the first intervention group, participants receive yoga techniques by yoga treatment for 6 consecutive days in addition to routine breastfeeding training, and in the second intervention group, participants receive routine breastfeeding training alone.
Main outcome variables
The primary consequence is the effect of yoga on the volume of milk of mothers with premature infants.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053619N1
Registration date:2022-01-19, 1400/10/29
Registration timing:registered_while_recruiting
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
fatemeh karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3232 5887
Email address
karimifateme711@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-11-11, 1401/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga on the volume and composition of breast milk in premature infants
Public title
The effect of yoga on breast milk
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Maternal desire to participate in research
Breastfeeding by mother
Possibility of mother for breastfeeding during the day
Intrauterine age below 34 weeks
Written order from the doctor stating that breastfeeding is allowed by the mother
To be primiparous means not to have a previous pregnancy that even leads to abortion.
Mothers who spend 4-6 days after giving birth
Exclusion criteria:
Anatomical problems in the breast such as nipple sagging and fissures and mastitis
Smoking and addiction
Taking drugs that affect milk production
Mothers with active tuberculosis and AIDS
Mothers who have had breast surgery
Mothers who have postpartum depression or experience a life crisis or sedative.
Mothers who consume lactating compounds
Mothers on treatment regimens and vegetables (vegetarian).
History of exercise or yoga during the last 3 months
Use of effective contraceptive methods on breastfeeding
Age
From 4 days old to 6 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
78
More than 1 sample in each individual
Number of samples in each individual:
2
Samples are taken from each participant twice, once on the first day and once on the sixth day.
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to one of two control and intervention groups in a ratio of 1: 1. Randomization is block randomization with blocks of size of 6. According to the random block division protocol (produced by Random Allocation Software), so that the researcher can not predict Slowly the next person in which group of intervention is placed. The codes will be placed inside the matte envelopes, respectively, and with the arrival of each new person, the envelope is opened and the person's belonging to the relevant group is determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the fact that after randomization, both mothers and researchers can not be blinded (because the type of intervention is known), so blinding can not be done in the first stage. On the other hand, measuring all the consequences in this study is objective and laboratory. Blinding will only be done for the laboratory evaluator and data analyst.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences،Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2022-01-03, 1400/10/13
Ethics committee reference number
IR.MUBABOL.HRI.REC.1400.169
Health conditions studied
1
Description of health condition studied
The effect of yoga on the volume and composition of milk of mothers with premature infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining the effect of yoga on breast milk volume in mothers of premature infants admitted to neonatal intensive care unit
Timepoint
Measurement of milk volume at the beginning of the study (first day) and the end of the study (sixth day)
Method of measurement
The volume of milk is measured using milk milked by an electric milking machine in a calibrated container.
Secondary outcomes
1
Description
Determining the effect of yoga on breast milk fat in mothers of premature infants admitted to neonatal intensive care unit
Timepoint
Measurement of breast milk fat based on the samples of the first day of the study and the sixth day of the study
Method of measurement
Cholesterol and triglyceride levels in breast milk were evaluated using a laboratory test
2
Description
Determining the effect of yoga on breast milk total protein in mothers of premature infants admitted to neonatal intensive care unit
Timepoint
Measurement of breast milk total protein using milk samples on the first and sixth days of the study
Method of measurement
Using laboratory amounts of total protein in milk samples
3
Description
Determining the effect of yoga on breast milk albumin in mothers of premature infants admitted to neonatal intensive care unit
Timepoint
Measurement of breast milk albumin based on the samples of the first day of the study and the sixth day of the study
Method of measurement
Study using laboratory values of albumin in milk samples of the first and sixth days
4
Description
Determining the effect of yoga on breast milk calcium in mothers of premature infants admitted to neonatal intensive care unit
Timepoint
Measurement of breast milk calcium based on the samples of the first day of the study and the sixth day of the study
Method of measurement
Using laboratory values of calcium in milk samples on the first and sixth days of the study
5
Description
Determining the effect of yoga on breast milk phosphorus in mothers of premature infants admitted to neonatal intensive care unit
Timepoint
Measurement of breast milk phosphorus based on the samples of the first day of the study and the sixth day of the study
Method of measurement
Using laboratory amounts of phosphorus in milk samples of the first and sixth days of the study
6
Description
Determining the effect of yoga on the weight of infants admitted to the neonatal intensive care unit
Timepoint
Measure the baby's weight on the first and sixth days
Method of measurement
Measure the baby's weight using a digital scale on the first and sixth days of the study
Intervention groups
1
Description
In the intervention group (yoga), 39 mothers were included in the study according to the inclusion criteria. In addition to teaching routine breastfeeding, mothers are taught yoga relaxation techniques by a yoga specialist from the first day to the sixth day in the presence of the researcher in a quiet room separate from the neonatal ward located in the gynecology clinic of Ayatollah Rouhani Hospital in Babol. It is given to include: 1- Exercising the muscles around the chest for 10 minutes while sitting on a chair 2- Asana movements while sitting on a chair for 5 minutes 3- Deep and gentle breathing with chest movements while sitting on a chair 5 minutes 4 - Relax for 25 minutes in a quiet and low light environment with a gentle song played by the laptop and lying on the floor. During the yoga intervention every day for 45 minutes for 6 The consecutive day after training is breastfeeding routine. For all mothers in the intervention group, on the first and sixth days after the end of the routine breastfeeding training class and performing the yoga relaxation technique, sampling is done between 11-12: 30 by milking with an electric breastmilk by Mami Wack, made in Germany, and the sample Our studies are selected from the second breastfeeding, which is three hours away from the first, and are measured in a non-sterile calibrated glass container by the first researcher and recorded in terms of volume in the questionnaire, and 5 ml of breast milk by The sterile syringe is taken and placed in a container containing an ice pack to be transferred to the freezer of the Biochemistry Laboratory of Babol University of Medical Sciences at -80 ° C for storage for biochemical tests. Glyceride), albumin and total protein, calcium and phosphorus with a spectrophotometer made in England, model (Unico 9344) with accurate measurement of mg / dl by a laboratory expert in the form of blind and for all samples centrifuged (by Clement 2000 available in the laboratory) according to the instructions Standard Mel Kit (Pars Azmoon made in Iran) is measured.
Category
N/A
2
Description
39 mothers with inclusion criteria who are on days 4-6 after delivery, in the control group after routine breastfeeding training by a trained researcher (student) and based on a checklist in the neonatal intensive care unit Takes. The mother first washes her hands and sits on a comfortable chair in the breastfeeding room. Environmental conditions such as dimming and protecting the fabric provide comfort to the mother. An explanation of the operation of the electric breast pump in the ward is given to the mother. The first milking time after the mother wakes up is around eight o'clock in the morning. The samples of our study are selected from the second breastfeeding, which is three hours away from the first. For all mothers in the control group, sampling is done fifteen minutes after the end of the routine breastfeeding training class at eleven and fifteen minutes on the first and sixth days. Milk is milked by German Mami Vak electric milking machine with the presence of a researcher and measured in a non-sterile graduated glass container based on milliliters by the first researcher and recorded with the name of mother and baby and milking time and milk volume and direction. Laboratory examination is kept at -80 ° C in the refrigerator of the biochemistry department of Babol University of Medical Sciences.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani hospital
Full name of responsible person
Ebrahim Hejazian
Street address
Ayatollah Rouhani Hospital، Afrooz St، Babol Town
City
Babol
Province
Mazandaran
Postal code
47176-477745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47146-47745
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
50
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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
009832325887
Fax
+98 11 3219 0181
Email
karimifateme711@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh karimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
karimifateme711@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh karimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3232 5887
Email
karimifateme711@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
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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