Protocol summary

Study aim
1- Determining and comparing the effect of Jacopsen relaxation and foot reflexology on breastfeeding adequacy of preterm infants in the two intervention groups 2- Determining the effect of Jacopsen relaxation and foot reflexology on breast milk volume of preterm infants in two intervention groups
Design
The randomized clinical trial with parallel control group.
Settings and conduct
Jacopsen's reflexology and relaxation massage for the intervention group will be performed for nine days in the maternity ward of Ghaem Hospital. The adequacy of breastfeeding will be measured using a questionnaire. They will complete the next day. The milk volume will be measured by the researcher on the first, third and ninth day in two groups using an electric milking machine.
Participants/Inclusion and exclusion criteria
Inclusion criteria in summary include: mother age is a maximum of 20 and a maximum of 35. The mother has no history of breast surgery. Be able to understand writings and verbal instructions, express anxiety verbally. The baby should be between 36-34 weeks old. The baby should be hospitalized in the ward. The baby should not have any other problem. Continue to participate in the study. Occurrence of the disease in the mother during the study. Taking drugs that increase breast milk such as metoclopramide.Neonatal intubation need, vital signs disorder, bleeding, IVH grade 4, long-term NPO of the infant during the study. Maternal discharge earlier than the end of the intervention
Intervention groups
The first group of mothers who experience foot reflexology. The second group of mothers experience Jacobsen relaxation.
Main outcome variables
Sufficient lactation; volume of milk

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191207045635N1
Registration date: 2021-02-02, 1399/11/14
Registration timing: prospective

Last update: 2021-02-02, 1399/11/14
Update count: 0
Registration date
2021-02-02, 1399/11/14
Registrant information
Name
elham khanmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3622 4233
Email address
khanme961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Jacopsen's relaxed body and foot reflexology on breastfeeding adequacy and breast milk volume in premature infants
Public title
Comparison of the effect of Jacopsen's relaxed body and foot reflexology on breastfeeding adequacy and breast milk volume in premature infants
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the mother is between at least 20 and at most 35 years old Be literate, be able to understand writing and verbal instructions, express verbal anxiety. The mother tends to breastfeed The mother has no history of serious or chronic illness, such as cardiovascular disease or mental illness (postpartum depression, schizophrenia, according to the mother), according to the mother. The mother is not addicted to smoking and drugs, especially cocaine and derivatives, as the mother says. The mother does not take drugs that are contraindicated during breastfeeding, such as doxepin tricyclic antidepressants, iodine compounds, gold salts, salicylates, and anticonvulsants during the intervention. The mother has no history of breast surgery and no history of injury or wound at the site of reflexology and no breast problems (fissures, congestion, mastitis and breast abscess). The mother should not take lactation-enhancing drugs, including metoclopramide.
Exclusion criteria:
The mother's unwillingness to continue participating in the research Incidence of disease in the mother during the study. Taking drugs that increase breast milk, such as metoclopramide. Neonatal intubation need, vital signs disorder, bleeding, IVH grade 4, long-term NPO of the infant during the study
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
They will be invited to the study by available sampling and will be randomly divided into two groups of foot reflexology intervention and Jacopsen relaxation without replacement. A simple random selection of one of the groups and sampling will begin.
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 Mashhad Collge of Nursing and Midwifery
Street address
Faculty of Nursing and Midwifery, Ibn Sina St., Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.035

Health conditions studied

1

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

Primary outcomes

1

Description
Breastfeeding adequacy score in the breastfeeding questionnaire
Timepoint
Assess the adequacy of breastfeeding before the intervention and twenty-one days after the intervention
Method of measurement
Breastfeeding adequacy questionnaire

Secondary outcomes

1

Description
Volume of milk using a graduated scale one hour after the end of breastfeeding and two hours after the intervention
Timepoint
The volume of milk in the first days (once), third and ninth of the intervention will be measured one hour after the end of breastfeeding and two hours after the intervention by Philips electric milking machine using a calibrated scale by the researcher in two groups.
Method of measurement
Breast milk will be milked using a Philips electric breast pump and milk volume will be measured using a calibrated gauge.

Intervention groups

1

Description
The first intervention group of foot reflexology: which includes the preparation and warm-up steps and stimulation and massage techniques that will be performed by the researcher once a day for nine days in the rest room of mothers in the nicu ward of Ghaem Hospital. The entire floor and back surface. The foot is massaged for one minute, then the reflex areas of the breast and the solar plexus are pressed and rubbed for 5 minutes for each foot (the intensity of the pressure should be such that it feels numb in position). Mothers are taught how to perform reflexology by a researcher.Milk volume will be measured in the first days (once), third and ninth of the intervention. The volume of the milk will be measured one hour after the end of breastfeeding and two hours after the intervention by the Philips electric milking machine using a graduated scale by the researcher in two groups. The adequacy of breastfeeding in the two groups of mothers on the first day and twenty-one days later at the time of the mother's visit to examine the baby will be assessed by a questionnaire.
Category
Other

2

Description
The second intervention group will experience Jacobs relaxation in nine days in the rest room of mothers in the neonatal ward of Ghaem Hospital by the researcher. In the Jacobsen relaxation group, the mother was first taught the practical technique. Jacobson was practically performed for 35 to 45 minutes by the researcher for the mother. It will be in the form of contracting separate muscles for 5 seconds and then relaxing the muscles for 10 seconds. These movements start first from the muscles of the head, face and neck regularly and in The middle and lower extremities of the body include the contraction of the muscles of the lower back, serine, thighs, legs, and toes.Milk volume will be measured in the first days (once), third and ninth of the intervention. The volume of the milk will be measured one hour after the end of breastfeeding and two hours after the intervention by the Philips electric milking machine using a graduated scale by the researcher in two groups. The adequacy of breastfeeding in the two groups of mothers on the first day and twenty-one days later at the time of the mother's visit to examine the baby will be assessed by a questionnaire.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Elham Khan Mohammadi
Street address
At the beginning of Ahmadabad Street, Dr. Ali Shariati Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
Quaem.Medical.Center@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad School of Nursing and Midwifery
Full name of responsible person
Mohsen Taqfadi
Street address
Mashhad School of Nursing and Midwifery, Doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
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 School of Nursing and Midwifery
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
Tahereh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashhad School of Nursing and Midwifery, Doctora intersection
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
Dr. Tahereh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1512
Fax
+98 51 3859 7313
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
Elham Khan Mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 104. Imamate 41. Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3609 7388
Fax
+98 51 3859 7313
Email
khanme961@mums.ac.ir
Web page address
https://nurse.mums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
After reading the information about the main outcome.
When the data will become available and for how long
10 months after printing
To whom data/document is available
All researchers can apply for it.
Under which criteria data/document could be used
Data and results for all researchers and for research purposes The context of diabetes will be available.
From where data/document is obtainable
SadeghiT@mums.ac.ir
What processes are involved for a request to access data/document
The data will be available to the applicant within one month after reviewing and confirming the application Will be located.
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