The aim of this study was to investigate the effect of ergonomic intervention on successful breastfeeding and musculoskeletal disorders risk reduction. 104 healthy mothers without musculoskeletal disorders and deficiencies with healthy new born infants with normal weight were randomly divided into ergonomic intervention group and control group. Every mother in the intervention group received information about ergonomic positions and interventions of breastfeeding. Both groups were followed for 6 months. Every 2 months the data of discomfort by using visual analogue scale and musculoskeletal disorder risks by RULA of mothers and infants weight and height were collected and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042317398N1
Registration date:2015-06-06, 1394/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-06, 1394/03/16
Registrant information
Name
Marjan Kiani
Name of organization / entity
SUMS
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
kiani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ergonomic intervention effect on successful breastfeeding and musculo skeletal disorders risk reduction in mothers
Public title
Ergonomic breastfeeding position correction effect on infant growth curve.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: healthy mothers; healthy new born infants
Exlusion criteria: mothers with musculo skeletal disorders; mothers with deficiency
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Shiraz Univeresity of Medical Sciences
Street address
Shiraz Univeresity of Medical Sciences building, Palestine street, Shiraz
City
Shiraz
Postal code
Approval date
2015-04-13, 1394/01/24
Ethics committee reference number
CT-9379-7439
Health conditions studied
1
Description of health condition studied
effect of ergonomic interevention on successful breastfeeding and musculoskeletal disorders risk reduction
ICD-10 code
M99
ICD-10 code description
Biomechanical lesions, not elsewhere classified
Primary outcomes
1
Description
comfort intensity
Timepoint
2, 4 and 6 months after intervention
Method of measurement
Visual Analogue Scale
2
Description
musculoskeletal disorders risk
Timepoint
2, 4 and 6 months after intervention
Method of measurement
RULA
3
Description
breastfeeding success
Timepoint
2, 4 and 6 months after intervention
Method of measurement
infant height and weight growth curves
Secondary outcomes
1
Description
musculoskeletal disorderes risk evaluation
Timepoint
before and 2, 4 and 6 months after intervention
Method of measurement
RULA grade
2
Description
infant height and weight growth curve
Timepoint
2, 4 and 6 months after intervention
Method of measurement
comparison of infant growth curve with index growth curves
Intervention groups
1
Description
ergonomic breastfeeding positions training and correction by observing each person in intervention group for 10 minutes while breastfeeding every 2 months for 6 months
Category
Prevention
2
Description
no intervention on control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valfajr health centers
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Enqelab martyrs health centeres
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marjan Kiani
Street address
Health college, Razi Blvd. , Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marjan Kiani
Position
B.Sc. of Physiotherapy
Other areas of specialty/work
Street address
Health college, Razi Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
marjankiani66@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marjan Kiani
Position
B.Sc. of Physiotherapy
Other areas of specialty/work
Street address
Health school of SUMS, Razi Blvd. ,Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1009
Fax
Email
marjankiani66@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marjan Kiani
Position
MS.c. student of Ergonomics
Other areas of specialty/work
Street address
Health college, Razi Blvd. , Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
marjankiani66@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)