Protocol summary

Summary
The purpose of this trial is to determine the effect of reflexology on breast milk of women with preterm infants. 74 lactating women with preterm infants aged 7-54 days hospitalized in the Alzahra or Taleganie hospitals-Tabriz who have inadequate milk supply were be randomly assigned into two treatment and control groups through stratified [according to recruitment place, multiple or singleton, and infant age (two groups of 7-30 and 31-54)] block randomization. Sequentially numbered opaque sealed envelopes, including a piece of paper with group name written on it, will be used to conceal the allocation sequence. The reflexology will be used on the feet, 10 minutes massage on each foot, once a day for 7 days. The massage will be done on breast, pituitary and solar plexus points in the intervention group and on the shoulder, sciatica and eye points in the control group by the researcher on the first, fourth and seventh days and by the women on the second, third, fifth and sixth days. The researcher will educate the women how to do the massage on the first day and massage will be done under supervision of the researcher on the second day. The main outcomes are: The volume of milk expressed using the electric pump milk by the researcher's help (2 hours after the last feeding 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, fourth and seventh days of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201501073706N24
Registration date: 2015-03-05, 1393/12/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-03-05, 1393/12/14
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy- Tabriz University of Medical Sciences
Expected recruitment start date
2015-03-06, 1393/12/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reflexology on breast milk of women with premature hospitalized newborns: a randomized control trial
Public title
The effect of reflexology on breast milk of women with premature hospitalized newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lactating women who have a singleton or twin preterm infant (s) (gestational age of 28.0 to 37.0 weeks) aged 7-60 days hospitalized at the neonatal unit or neonatal intensive care unit; have willing to continue breastfeeding; have 30% or more decreased milk supply compared to the peak volume (based on maternal account) or have inability to provide adequate breast milk to meet infant nutritional needs and a neonatologist confirms the insufficient milk production; have permanent or temporary stay at the hospital during the seven days of intervention. Exclusion criteria: metabolic diseases in the infant (s); infection or sore of woman's feet; chronic systemic illness of the woman; inability to fill up the self-administered questionnaire; no Iranian nationality; occurrence of severe psychological problems for the woman such as death of a close relative in the previous 3 months; and intention to start using a drug which may have an effect on the milk production (e.g. metoclopramide, domperidone) or change dose of the drugs in the next 15 days
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: 74
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research Deputy, 3rd floor, Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz, East Azarbaijan
City
Tabriz
Postal code
Iran
Approval date
2015-02-01, 1393/11/12
Ethics committee reference number
93159

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, fourth and seventh days of intervention
Method of measurement
Squeezing through the electric pump

2

Description
volume of breast milk expressed during 24 hours
Timepoint
Before intervention- on the first, fourth and seventh days of intervention
Method of measurement
recording on the diary by the women

Secondary outcomes

1

Description
volume of breast milk substitutions given to the infant during 24 hours
Timepoint
Before intervention, on the first, fourth, and seventh days intervention
Method of measurement
using nursing report

2

Description
infant weight gain
Timepoint
before intervention- on the first, fourth and seventh intervention days
Method of measurement
newborn weighting scale with a precision of one gram

3

Description
The infant's heart rate
Timepoint
before intervention, خn the first, fourth and seventh intervention days
Method of measurement
Pulse oximeter

4

Description
Infant oxygen saturation
Timepoint
before intervention, on the first, fourth, seventh intervention days
Method of measurement
Pulse oximeter

5

Description
Depression score of the women
Timepoint
Before intervention, the seventh day of intervention
Method of measurement
Through self-report questionnaire DASS

6

Description
Anxiety score of the women
Timepoint
Before intervention, the seventh day of intervention
Method of measurement
از طریق پرسشنامه خود گزارشی DASS

7

Description
stress score of the women
Timepoint
Before intervention, the seventh day of intervention
Method of measurement
Through self-report questionnaire DASS

8

Description
The proportion of infant feeding with expressed breast milk
Timepoint
seventh day of intervention
Method of measurement
The women report table and nursing reports in the infant record

9

Description
exclusive breastfeeding
Timepoint
seventh day of Intervention
Method of measurement
Nursing report and woman report

10

Description
woman satisfaction of the intervention
Timepoint
seventh day of intervention
Method of measurement
woman report

11

Description
woman satisfaction from breastfeeding
Timepoint
the seventh day of Intervention, Seven days after end of intervention
Method of measurement
woman report

12

Description
occurrence of adverse events
Timepoint
During the study
Method of measurement
woman report

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 seven days
Category
Rehabilitation

2

Description
control group: reflexology on the eye, shoulder and back points of feet for 20 minutes (10 minutes for each foot) once a day for seven days
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Parisa Mirzaee
Street address
Crossroads Baghshmal, 17 Shahrivar Street, Tabriz
City
Tabriz

2

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Parisa Mirzaee
Street address
Rah Ahan, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Research Deputy, 3rd floor,Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz 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
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Parisa Mirzaee
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Iran
Phone
+98 41 3544 6210
Fax
Email
yoosefe.zahra@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Iran
Phone
+98 41 3479 6770
Fax
Email
alizades@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Iran
Phone
+98 41 3479 6770
Fax
Email
alizadas@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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