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Clinical trial of the comparison of effect of acupressure and reflexology on volume of milk in lactating mothers with lactation insufficiency

Protocol summary

Summary
Inclusion criteria: recent singleton delivery, at least 10days and a maximum of 6 months after delivery, lack of maternal and neonatal illness, not taking any medication or effective treatment on breastfeeding by mother, lack of injuries and wounds at the place of applying the acupressure and reflexology. In this research, 90 lactating mothers with lactation insufficiency who had inclusion criteria, were surveyed. The individuals were randomly included in three groups of acupressure, reflexology and control using the envelope. Common breastfeeding trainings were given to each group during 12 consecutive days of intervention, Moreover, acupressure treatment was carried out on Si1,Li4 and GB21 points in the mothers who were in acupressure group. Also, the mothers in reflexology group received foot reflexology treatment. The rate of mother’s milk volume and infant`s weight was evaluated in all three groups before intervention , 2 and 4 weeks after intervention .The present study was a single-blinded study. In order to prevent the researcher orientation, mother`s milk volume and infant`s weight have been measured by questioner.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013112415525N1
Registration date: 2014-05-08, 1393/02/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-08, 1393/02/18
Registrant information
Name
Mitra Savabi Esfahani
Name of organization / entity
Department of Midwifery, School on Nursing and Midwifery, Isfahan University of Medical science.
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2971
Email address
m_savabi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2013-04-10, 1392/01/21
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the comparison of effect of acupressure and reflexology on volume of milk in lactating mothers with lactation insufficiency
Public title
Comparison of the effect of acupressure and reflexology on volume of milk in lactating mothers.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: recent singleton delivery; at least 10 days and a maximum of 6 months after delivery; lack of maternal and neonatal illness; not taking any medication or effective treatment on breastfeeding by mother; lack of injuries and wounds at the place of applying the acupressure and reflexology. Exclusion criteria: unwillingness to continue the participation in research; the incidence of disease in mother or infant during the study; not to weigh the infant properly; or need to therapeutic interventions. The aim of this study was to compare the effect of acupressure and reflexology on volume of milk in lactating mothers.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Isfahan university of medical sciences
Street address
Azadi Square.Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2013-01-08, 1391/10/19
Ethics committee reference number
391377

Health conditions studied

1

Description of health condition studied
The connection of acupressure, reflexology and mother`s breastfeeding.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
mother`s milk volume, infant`s weight
Timepoint
before intervention , two and four weeks after intervention
Method of measurement
Mother`s milk volume was measured by electric milking device and infant`s weight was measured by standard weighing machine.

Secondary outcomes

empty

Intervention groups

1

Description
Group 1 of intervention: acupressure was carried out onSi1, Li4 and GB21 points, and breastfeeding teaching was conducted, too.
Category
Other

2

Description
Group 2 of intervention: foot reflexology was done along with breastfeeding teaching.
Category
Other

3

Description
Group 3 of control: breastfeeding teaching was presented alone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahmadi Health Center
Full name of responsible person
Gasemipour
Street address
Ahmadi Health Center, Damavand Street, Imam Hossein Square, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mitra Savabi Isfahani
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Mitra Savabi Isfahani
Position
Faculty member of Nursing and Midwifery school
Other areas of specialty/work
Street address
Azadi Square,Isfahan University of Medical Sciences, isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2936
Fax
Email
m_savabi@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Master Science in Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1668 0042
Fax
Email
Mahboubeh Valiani@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
shohrehBerenjiSoogheh
Position
Faculty member- lecturer
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences.Isfahan, Isfahan, Iran
City
Tehran
Postal code
Phone
Fax
Email
shohrehberenji@yahoo.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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