This study will be done with aim to investigate the effectiveness of back massage and reflexology on the volume of milk of preterm infants’ mothers admitted to the NICU ward of hospitals affiliated by Isfahan University of Medical Sciences, 2015. This study is a non-blind clinical trial. The study population consists of mothers with 29 _ 33 week premature infants admitted to the NICU wards of Behesti and Al-Zahra hospitals. Inclusion criterion is undergoing cesarean and main exclusion criterion is using drug affecting lactation. In this study, 75 eligible mothers will be selected and will randomly be assigned in to 3 groups (2 experimental and 1 control groups). Before the intervention, all mothers will be asked to milk themselves by milkmaid for 15 minutes and the volume of milk will be measured in all of them. In the first study group reflexology will be done for each leg separately for 20 minutes, daily for 6 days. In the second experimental group, back massage of simple slow stroke type will be done with open fingers on either sides of the spinal column and shoulders for ten minutes for 6 consecutive days. The control group did not receive any massage. At the end of the study, mothers will be asked to milk themselves by milkmaids and the volume of milk will be measured again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120126153N3
Registration date:2017-04-01, 1396/01/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-01, 1396/01/12
Registrant information
Name
Atena Mohammadpour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4203 1634
Email address
atenamohammadpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Esfahan University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of back and reflexology massage on milk volume of mothers of preterm infants
Public title
Compare the effects of two massage method on milk volume of mothers of preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mothers with29 _ 36 weeks premature infants; The absence of any damage, ulcers and tumors in massage area in the back and legs, passing three days from the childbearing; undergoing cesarean; No history of back massage and reflexology.
Exclusion criteria: using drug affecting the lactation including antibiotics, anticonvulsants and antipsychotics.
Age
From 7 months old to 9 months old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done through drawing a card using encoded on the cards 1,2,3. Patients randomly select one of the cards and their group will be set according to the number they choose
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee , Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Hezarjarib street
City
Esfahan
Postal code
Approval date
2016-09-11, 1395/06/21
Ethics committee reference number
IR.MUI.REC.1394.3.462
Health conditions studied
1
Description of health condition studied
mothers' Lactation
ICD-10 code
O92.5
ICD-10 code description
Suppressed lactation
2
Description of health condition studied
preterm infant
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Milk volume
Timepoint
Baseline, the end of the study
Method of measurement
Inserted milk jugs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group reflexology will be done for each leg separately for 20 minutes, totally 40 minutes(15 minutes general reflexes and 5 minutes specialized reflexes) daily during 6 sessions.
Category
Treatment - Other
2
Description
Intervention group 2: In this group back massage of simple slow stroke type with open fingers on either side of the spine and shoulder will be done for ten minutes for 6 days.
Category
Treatment - Other
3
Description
The control group will not receive any massage
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Atena Mohammadpour
Street address
Shahid Beheshti Hospital, Motahari street, Pol Felezi
City
Esfahan
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Atena Mohammadpour
Street address
Sefeh Boulevard
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Akram Mazaheri
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, Hezarjarib Street
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Atena Mohammadpour
Position
Msc student in Emergency nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, Hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
atenamohammadpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Talakoub
Position
Msc student in Paediatric nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, Hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
talakoub@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atena Mohammadpour
Position
Msc student in Emergency nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, Hezarjarib street
City
Esfahan
Postal code
Phone
00
Fax
Email
atenamohammadpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)