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The effect of foot reflexology on the breast engorgement lactating mothers

Protocol summary

Study aim
The effect of foot reflexology on breast engorgement in lactating mothers
Design
A randomized clinical trial using two-way blocking method with a control group, parallel groups and a sample size of 80 lactating mothers
Settings and conduct
The study investigated 80 lactating mothers in the first 3-5 days after delivery referring to Mashhad's number one health center for breast engorgement. With observing moral points, obtaining informed consent, explanation of the goals, having the entry and exit conditions, then if the score for breast engorgement was greater than or equal to 2, the sample was selected as the sample. For the intervention group, in addition to routine care, reflexology of the foot performed daily by a mother for a period of 20 minutes. The control group received a routine care (lactation technique training, repeated feeding, warm compress).
Participants/Inclusion and exclusion criteria
Inclusion criteria : Healthy in terms of medical disease or obstetric, Non-use of herbal topical drugs or chemicals, No mastitis, breast abscess and nipple scars, Mothers with body temperature below 38 ° C, Breast engorgement in the first 5 days after delivery, Obtaining a minimum score of 2 out of 19 from the degree of engorgement checklist, Non-use of Antibiotic, Breastfeeding, Gestational age 37-42 weeks, Age of a neonate 3-5 days, singleton birth Exit criteria: The use or need of any anti-inflammatory drug, or the occurrence of mastitis or breast abscess during the study, non-lactation
Intervention groups
The intervention group, foot reflexology and routine care control group
Main outcome variables
Consequences: The degree of breast engorgement severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190608043838N1
Registration date: 2019-06-19, 1398/03/29
Registration timing: retrospective

Last update: 2019-06-19, 1398/03/29
Update count: 0
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
Fatemeh Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3892 0173
Email address
mousavif5@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-01-20, 1397/10/30
Scientific title
The effect of foot reflexology on the breast engorgement lactating mothers
Public title
The effect of complementary medicine on breast engorgement
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian, Mashhad citizens Reading and writing skills Informed consent of willingness to participate in the study Contact number Healthy in terms of medical disease or obstetric Non-use of herbal topical drugs or chemicals No history of breast surgery No mastitis, breast abscess and nipple scars Mothers with body temperature below 38 ° C Breast engorgement in the first 5 days after delivery Obtaining a minimum score of 2 out of 19 from the degree of engorgement check list Non-use of Antibiotics Breastfeeding and willing to lactation Gestational age of 42 to 37 weeks Age of a child 3-5 days Singleton birth
Exclusion criteria:
Increase in temperature up to more than 38 ° C The use or need of any anti-inflammatory drug during the intervention Reluctance to continue cooperation in the study The occurrence of mastitis or breast abscess during the study Non-lactation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Distribution of subjects into two groups (intervention, control) was done by random allocation using two-way blocking method via software. Since no contact between participants in the two groups was a principle, so the individual randomization was done in a special way based on the week days. Considering that individuals should have consulted two days after the first visit to assess the severity of engorgement, new participants who were going to included in the study should joined on Saturday or Sunday (the first group on Saturday and the second group on Sunday), thus choosing one of the two intervention or control groups as the first or second group was randomly (using a coin).
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
The Ethics Committee of Mashhad University of Medical Sciences
Street address
No. 41 ، Daneshjo street 34,
City
mashhad
Province
Razavi Khorasan
Postal code
9188955395
Approval date
2018-06-19, 1397/03/29
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.014

Health conditions studied

1

Description of health condition studied
Breast engorgement in the lactating mothers
ICD-10 code
N64.89
ICD-10 code description
Other specified disorders of breast

Primary outcomes

1

Description
Obtaining minimum score 2 out of 19 from the breast engorgement check list
Timepoint
The first day before and after intervention, the third day after intervention
Method of measurement
Standard breast engorgement score check list

Secondary outcomes

1

Description
Breast pain severity
Timepoint
The first day before and after intervention, the third day after intervention
Method of measurement
Pain visual matching scale

2

Description
Number of previous pregnancies
Timepoint
Study in the end
Method of measurement
Statistical tests

3

Description
Type of delivery
Timepoint
Study in the end
Method of measurement
Statistical tests

4

Description
History of breastfeeding
Timepoint
Study in the end
Method of measurement
Statistical tests

Intervention groups

1

Description
Intervention group: Foot reflexology was performed for 20 minutes, 10 minutes on each foot, in three zones of the solar network (3 minutes), breast(3 minutes), lymphatic system(3 minutes). One minute was allocated for general massage, once a day for three consecutive days by mothers.
Category
Treatment - Other

2

Description
Control group: Routine care(correct lactation training, frequent lactation, hot compress)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad's health center number one
Full name of responsible person
Fatemeh Mousavi
Street address
68 Vakilabaad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188955395
Phone
+98 51 3501 8011
Email
mousavif5@mums.ac.ir

2

Recruitment center
Name of recruitment center
Hojjat health care center
Full name of responsible person
Fatemeh Mousavi
Street address
17 Daroodi street
City
Mashhad
Province
Razavi Khorasan
Postal code
9175678956
Phone
+98 51 3501 8011
Email
mousavif5@mums.ac.ir

3

Recruitment center
Name of recruitment center
Imam Hadi health care center
Full name of responsible person
Fatemeh Mousavi
Street address
Imam Hadi street
City
Mashhad
Province
Razavi Khorasan
Postal code
9188678544
Phone
+98 51 3501 8011
Email
Mousavif5@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
university Street
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3882 3251
Email
tafaghdim@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
Fatemeh Mousavi
Position
Master of midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ebne Sina Street, Doctera junction
City
Mashhad
Province
Razavi Khorasan
Postal code
9188955395
Phone
+98 51 3859 1511
Email
mousavif5@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Mousavi
Position
Master of midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ebne Sina Street, Doctera junction
City
Mashhad
Province
Razavi Khorasan
Postal code
9188955395
Phone
+98 51 3859 1511
Email
mousavif5@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Mousavi
Position
Master Degree midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Daneshghah st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188955395
Phone
+98 51 3892 0173
Fax
Email
mousavif5@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the required data provided in the thesis
When the data will become available and for how long
Right after publishing the thesis and the article
To whom data/document is available
Students and researchers
Under which criteria data/document could be used
In case of attaining faculty library permission
From where data/document is obtainable
Faculty of nurse and midwifery, Ibne Sina st, Mashhad, Iran Tel: 00985138591511
What processes are involved for a request to access data/document
It's referred to published article and faculty library
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