To assess the effect of infant massage on postpartum blues and mother-infant attachment in primiparous women
Design
This is a randomized clinical trial, in which 90 eligible primiparous women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible primiparous women who will refer to the Comprehensive Health Centers of Hamadan City during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Aged 20 to 35;
Score of blues between 15 and 10 based on the Edinburgh questionnaire;
Term pregnancy;
Uncomplicated normal delivery;
Being literate;
The stability of couples' life;
Satisfaction with the baby's gender
Exclusion criteria:
Psychological problems;
History of depression in the first-degree family
Intervention groups
Intervention group: Routine care and massage of the baby by touching the baby's body tissue with regular movement for 15 minutes daily for 6 weeks to improve the functioning of the nervous system of the body, muscle, skin, joints and circulation
Control group: Just routine care
Main outcome variables
Primary outcome: Assessing the score of postpartum blues
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N254
Registration date:2018-12-15, 1397/09/24
Registration timing:registered_while_recruiting
Last update:2018-12-15, 1397/09/24
Update count:0
Registration date
2018-12-15, 1397/09/24
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of infant massage on postpartum blues and mother-infant attachment in primiparous women: a randomized clinical trial
Public title
Effect of infant massage on postpartum blues and mother-infant attachment in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 20 to 35;
Score of blues between 15 and 10 based on the Edinburgh questionnaire;
Term pregnancy;
Uncomplicated normal delivery;
Being literate;
The stability of couples' life;
Satisfaction with the baby's gender
Exclusion criteria:
Psychological problems;
History of depression in the first-degree family
Age
From 20 years old to 35 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
Random assignment of the patients to the intervention, and control groups through the drawing of lots
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.UMSHA.REC.1397.556
Health conditions studied
1
Description of health condition studied
Postpartum blues
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance
Primary outcomes
1
Description
Assessing the score of mother's postpartum blues
Timepoint
Before intervention and at second, forth, and sixth weeks after intervention
Method of measurement
Using Edinburgh standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care and massage of the baby by touching the baby's body tissue with regular movement for 15 minutes daily for 6 weeks to improve the functioning of the nervous system of the body, muscle, skin, joints and circulation
Category
Treatment - Other
2
Description
Control group: Just routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers of Hamadan City
Full name of responsible person
Fatemeh Rezji
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemeh.razaji6599@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Rezji
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemeh.razaji6599@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Specialist of Community Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
pparsa2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available