The purpose of this trial is to determine the effect of reflexology on milk production in mothers with premature neonates.45 lactating women with preterm infants aged 4-7 days hospitalized in the Shohada Hospitals -Quchan who were be randomly According to the random numbers table assigned into three treatment and placebo and control groups . The reflexology will be used on the feet, 10 minutes massage on each foot,once a day for3 days. The massage will be done on breast, pituitary and solar plexus points in the intervention group and on the leg in the placebo and the control group any massage by the researcher on the first and three days. The main outcomes are: The volume of milk expressed using the electric pump milk by the researcher's help (2 hours after the last Expressing and at least half an hour after the massage) and volume of 24 hours expressed breast milk reported on the recording table by the women. The outcomes were measured on the first and three days of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112425232N1
Registration date:2016-01-07, 1394/10/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-07, 1394/10/17
Registrant information
Name
Narges Derakhshan
Name of organization / entity
Gonabab University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
derakhshan.n@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy- Gonabad University of Medical Sciences.
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on milk production in mothers with premature neonates
Public title
feeding problems of Premature Infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lactating women who have a singleton or twin preterm infant (s) (gestational age of
28 to34 weeks) aged4-7 days hospitalized at the neonatal intensive care unit; Have neonates are breast-fed by nasogastric tube; Have willing to continue breastfeeding; Mother's have not disease affecting milk production (e.g. Nutrition disorders, depression, diabetes, dehydration); Mothers have not chronic diseases (e.g. cardiovascular disease or psychological disease, deep vein thrombosis and peripheral nerve diseases);The mothers avoiding use of any medication or treatment affecting on breastfeeding in during research; not infection or sore of woman's fee; No problems mammary (breast fissures, congestion, mastitis and breast abscesses); not occurrence of severe psychological problems for the woman such as death of a close relative or job loss).
Exclusion criteria: Unwillingness women to continuation of presence at research; intention to start using a drug which may have an effect on the milk production (e.g. metoclopramide, domperidone); If naonate require of endotracheal intubation and general condition ill.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
KHorasan Razavi, Gonabad, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Approval date
2015-12-23, 1394/10/02
Ethics committee reference number
IR.GMU.REC.1394.60
Health conditions studied
1
Description of health condition studied
Breast feeding
ICD-10 code
p92
ICD-10 code description
feeding problems of newborn
Primary outcomes
1
Description
The volume of milk expressed 2 hours after the last expression and at least half an hour after the massage
Timepoint
Before intervention - on the first and three days of intervention
Method of measurement
Squeezing through the electric pump
Secondary outcomes
1
Description
volume of breast milk expressed during 24 hours
Timepoint
Before intervention- on the firs and three days of intervention
Method of measurement
recording on the diary by the women
Intervention groups
1
Description
Intervention group: reflexology on the breast, solar
plexus and pituitary points on the feet for 20 minutes
(10 minutes on each foot), once a day for three days
Category
Prevention
2
Description
The control group: without action
Category
Prevention
3
Description
The placebo group: received a gentle massage on the legs for 20 minutes (10 minutes on each foot), once a day for three days
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Narges Derakhshan
Street address
Shohada Hospital, crossroads tarbiat, Quchan
City
Quchan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabab University of Medical Sciences
Full name of responsible person
Dr Mohammadpour Ali, Research and Tecnology Departmant of Gonabad University of Medical Scienses, Pr
Street address
Gonabab University of Medical Sciences
City
Gonabab
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabab University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabab University of Medical Sciences
Full name of responsible person
Narges Derakhshan
Position
Graduate Student in Nursing Education, Nursing chidren
Other areas of specialty/work
Street address
Gonabab University of Medical Sciences
City
Gonabab
Postal code
Phone
+98 51 5722 5027
Fax
Email
derakhshan.n@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Marum Eshghizadeh
Position
Graduate in Nursing Education, Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
m.eshghizadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narges Derakhshan
Position
Graduate Student in Nursing Education, Nursing children
Other areas of specialty/work
Street address
KHorasan Razavi, Gonabad, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
derakhshan.n@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)