Protocol summary

Summary
The Clinical trial was randomly done with the aim of determining the effect of Infant massage on postpartum blues of primiparous women on 54 target group who had Natural Vaginal Delivery during early November to mid December 2016. Inclusion criteria To have scores lower than 10 in Edinburg questionnaire in the day of delivery, the infant to be term and healthy, to have Apgar score higher than 7 and with the weight above 2500 gram, general situation of mother should be fine, and does not have the history of sever mental disorders and stress. Exclusion criteria are as follows: hospitalization of mother with infant for any reason during research, non-execution of massage during two consecutive days, lack of mother`s medical stability due to one of her relative`s death in accident in a way that prevent the massage to be done. Intervention group should massage their infants for about 15 minutes per day until the tenth day after delivery, massage their infant. In Control group, there was no intervention.The postpartum blues levels in the first, fourth and tenth day after delivery, and attachment mother and infant in the first and tenth day after delivery were assessed and compared in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121931475N1
Registration date: 2017-01-25, 1395/11/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-25, 1395/11/06
Registrant information
Name
Solmaz Kouhestani Mianji
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
kouhestanis921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-10-29, 1395/08/08
Expected recruitment end date
2016-12-01, 1395/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of infant massage by mother on postpartum blues in primiparous women: َA Randomized clinical trial with control group
Public title
The effect Of infant massage on postpartum blues
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Be primiparous; natural vaginal delivery must be done; to have Iranian nationality and be resident of Mashhad City; to have scores lower than 10 in Edinburg questionnaire in the day of delivery; the infant to be term and healthy; to have Apgar score higher than 7 and weight above 2500 gramme; pregnancy must be singleton and wanted; be educated( Learned); general situation of mother be fine; does not have the history of sever mental disorders and stress; does not have the history of two or more abortions, still births and infertility; do not suffer from undesirable pregnancy precussion. Exclusion criteria: Hospitalization of either mother or infant for any reason during research; non-execution of massage during two consecutive days; reluctancy of mother to continue cooperation; lack of mother`s medical stability due to one of her relative`s death in accident in a way that prevent the massage to be done, mothers being sick in away that fails to massage.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University Of Medical Sciences
Street address
College of Nursing and midwifery, Ibn-Sina street, Doctori crossroads, Daneshgah street, Mashhad, Iran.
City
Mashhhad
Postal code
13944-91388
Approval date
2016-09-24, 1395/07/03
Ethics committee reference number
IR.MUMS.REC.1395.350

Health conditions studied

1

Description of health condition studied
Postpartum Blues
ICD-10 code
F53
ICD-10 code description
Mental and behavioural disorders associated with the puerperium

Primary outcomes

1

Description
Postpartum Blues
Timepoint
1ST, 4th, 10th after delivery
Method of measurement
Edinburg Questinory

Secondary outcomes

1

Description
Attachment Of Infant and Mother
Timepoint
First and 10th day after Delivery
Method of measurement
Questionary

Intervention groups

1

Description
Infan massage for 15 minutes per day until the tenth day after delivery with Field techniqe in intervention group
Category
Prevention

2

Description
There was no intervention in Control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin hospital
Full name of responsible person
Street address
Omolbanin hospital,16th Bahjat street, Ayatollah Bahjat avenue, Mashhad, Iran
City
Mashhad

2

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Street address
Imam Reza hospital, Ibn-Sina street, Doctori crossroads, Daneshgah street, Mashhad, Iran.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Abedian
Street address
Mashhad University Of Medical Sciences, College of Nursing and midwifery, Ibn-Sina street, Doctori crossroads, Daneshgah street, Mashhad, Iran.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University Of Medical Sciences
Full name of responsible person
Zahra Abedian
Position
MSc
Other areas of specialty/work
Street address
Mashhad University Of Medical Sciences, College of Nursing and midwifery, Ibn-Sina street, Doctori crossroads, Daneshgah street, Mashhad, Iran.
City
Mashhhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
abedianz@mums.ac.ir; Kouhestanis921@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Zahra Abedian
Position
MSc
Other areas of specialty/work
Street address
Mashhad University Of Medical Sciences, College of Nursing and midwifery, Ibn-Sina street, Doctori crossroads, Daneshgah street, Mashhad, Iran.
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
abedianz@mums.ac.ir; kouhestanis921@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Solmaz Kouhestani
Position
MSc of Midwifery
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
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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