Protocol summary

Study aim
to determine the effect of foot reflexology on the volume and composition of breast milk in mothers of premature babies hospitalized in the neonatal intensive care unit.
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, on 74 mothers, Random Allocation Software was used for randomization.
Settings and conduct
The researcher will refer to the nicu department of Rohani Babol hospital and the samples will be selected according to the entry criteria. They will complete the demographic profile questionnaire. In the intervention group, 20 minutes of foot reflexology is performed daily for seven consecutive days, and sampling is done 30 minutes after reflexology, and reflexology is not performed in the control group. In both groups, milk will be milked from each breast for 15 minutes with the presence of the researcher.
Participants/Inclusion and exclusion criteria
The inclusion criteria include the mother's desire to participate in the research, the intrauterine age of the baby between 28 and 34 weeks, a written doctor's order based on the mother's permissibility of breastfeeding, and the exclusion criteria include stopping breastfeeding due to the clinical conditions of the newborns, the discharge of the baby during Intervention, death of the baby, absence of the mother even for one day during the seven days of the intervention, mothers who have postpartum depression.
Intervention groups
In the intervention group, 20 minutes of foot reflexology is performed daily for seven consecutive days, and reflexology is not performed in the control group.
Main outcome variables
Breast milk volume, breast milk cholesterol, breast milk triglycerides, breast milk albumin, breast milk total protein, breast milk calcium

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221220056872N1
Registration date: 2023-01-22, 1401/11/02
Registration timing: prospective

Last update: 2023-01-22, 1401/11/02
Update count: 0
Registration date
2023-01-22, 1401/11/02
Registrant information
Name
Fatemeh Norozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 1827
Email address
yasamannorouzi456@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-01, 1401/11/12
Expected recruitment end date
2024-02-01, 1402/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on the volume and composition of breast milk inmothers of premature infants admitted to the neonatal intensive care unit
Public title
The effect of foot reflexology on the volume and composition of breast milk inmothers of premature infants admitted to the neonatal intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mother's willingness to participate in the research Willingness to breastfeed Intrauterine age of the baby 28 to 34 weeks 8- Written order Written order The doctor is based on the permissibility of breastfeeding by the mother The mother must be primiparous, that is, she does not have a previous pregnancy that even leads to abortion
Exclusion criteria:
Cessation of breastfeeding due to the clinical conditions of the infants Discharge of the infant during the intervention Death of the infant Mother's unwillingness to continue participating in the study Absence of the mother even for one day during the seven days of the intervention Mothers with postpartum depression Having skin problems on the mother's foot such as an injury, wound or tumor or mass on the mother's foot to perform reflexology Consumption of milk-enhancing compounds, cigarettes and drugs or anticonvulsant and antipsychotic drugs by the mother Mother suffering from diseases that prohibit breastfeeding Use of contraceptive methods effective on breastfeeding The use of mothers who have therapeutic diets and vegetables
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
People will be included in the study if they are eligible based on the entry criteria and after obtaining written informed consent. Due to the fact that the subjects of the study do not enter the study at the same time, and the researchers cannot predict in advance which group each person who enters the study will belong to. To allocate the target group to one of the two study groups (two groups A and B), block randomization method with six blocks will be used. Then the participants will be assigned to one of two groups 1-control 2-intervention according to the block randomization protocol (produced by Random Allocation Software) with a ratio of 1:1:1, in a way that the researcher cannot predict. In which intervention group is the next person placed? Concealment of random allocation refers to the method used to perform a random sequence on the participants in the study, so that the assigned group is not known before the allocation of the individual. Without hiding the random sequence, there is a possibility of revealing the random sequence, which ultimately weakens the randomization process. Therefore, it is necessary to make a decision to accept or reject participation in the study first and complete the informed consent form and then the participants are assigned to each of the groups. Different methods can be used to hide random allocation. In this study, the method of sealed opaque envelopes with a random sequence will be used. Based on the sample size of this research, a number of opaque envelopes (in order to make the contents of the envelopes unclear) were prepared and each random sequence was created. It is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed. More about this source textSource text required for additional translation information Send feedbackSide panels
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medica l Science
Street address
Department of Nursing, Faculty of Nursing and Midwifery,Babol University of Medical Sciences,Ganj Afroz Road,Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.MUBABOL.REC.1401.132

Health conditions studied

1

Description of health condition studied
Breast feeding
ICD-10 code
P92
ICD-10 code description
Feeding problems of newborn

2

Description of health condition studied
Breastfeeding status of mothers
ICD-10 code
O92.5
ICD-10 code description
Suppressed lactation

Primary outcomes

1

Description
Breast milk volume
Timepoint
At the beginning of the study and on the seventh day after the reflexology intervention
Method of measurement
Expressed milk is measured in milliliters in a graduated container.

Secondary outcomes

1

Description
total protein and albumin in breast milk
Timepoint
At the beginning of the study and on the seventh day after the reflexology intervention
Method of measurement
Biochemical index of milk total protein and albumin with a spectrophotometric device made in England model (Unico 9344) with the accuracy of mg/dL, for all samples centrifuged by Clement device (2000 available in the laboratory) total protein and albumin of breast milk It will be recorded based on standard registration instructions and based on mg/dL.

2

Description
fat (cholesterol and triglyceride) in breast milk
Timepoint
At the beginning of the study and on the seventh day after the reflexology intervention
Method of measurement
Biochemical index of milk cholesterol and triglycerides with spectrophotometric device made in England model (Unico 9344) with the accuracy of mg/dL, for all samples centrifuged by Clement device (2000 available in the laboratory) breast milk cholesterol and triglycerides It will be recorded based on standard registration instructions and based on mg/dL.

3

Description
calcium in breast milk
Timepoint
At the beginning of the study and on the seventh day after the reflexology intervention
Method of measurement
Biochemical index of milk calcium with a spectrophotometric device made in England, model (Unico 9344) with the accuracy of mg/dL, for all samples centrifuged by the Clement device (2000 available in the laboratory) of breast milk calcium based on standard registration instructions and based on It will be recorded on a mg/dL basis.

Intervention groups

1

Description
Intervention group: Foot reflexology includes general reflex (preparation, heating and stimulation) and special reflex (massage of pituitary, breast and solar points) for 20 minutes for both legs and 10 minutes for each leg during seven consecutive days. Seven sessions are held daily. 30 minutes after the end of reflexology, milking starts from each breast for 15 minutes.
Category
Other

2

Description
Control group: The control group are mothers who will only be taught routine breastfeeding by the researcher (Master's student). Out of 37 mothers of premature babies in the first group (control group), sampling is done around 11:30. Milk is expressed from each breast for 15 minutes by an electric milking machine in the presence of a researcher (Master's student) and measured in milliliters in a graduated container, and the volume of milk is recorded with the mother's name, baby's name, time, day and date of milking. .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mazandaran, Babol, Ayatollah Rouhani Hospital
Full name of responsible person
Dr. Asghar Molazadeh
Street address
Ayat Rohani Hospital, Keshavarz Blvd, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
4841849533
Phone
+98 11 3223 8301
Email
www.rohanibabol@gmail.com
Web page address
http://bankpezeshkan.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajab Nia
Street address
Research and Technology Vice-Chancellor, University of Medical Science, Ganj Afrooz St, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0149
Fax
+98 11 3219 0181
Email
ramazan@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
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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Norouzi Nodehi
Position
Nursing master's student in neonatal special care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department of Nursing, Faculty of Nursing and Midwifery,Babol University of Medical Sciences,Ganj Afroz Road,Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
4841849533
Phone
+98 11 3474 1827
Email
yasamannorouzi456@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parvin Aziznejad
Position
Teaching faculty of Babol University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
- Babol - Ganj Afroz Road - Babol University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Nursing
City
babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0181
Email
aziznejadroshan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Norouzi Nodehi
Position
Nursing master's student in neonatal special care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department of Nursing, Faculty of Nursing and Midwifery,Babol University of Medical Sciences,Ganj Afroz Road,Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
4841849533
Phone
+98 11 3219 0181
Email
yasamannorouzi456@gmail.com

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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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