Evaluation the effect of home visit on depression of mothers with low birth weight babies
Design
This clinical trial study had parallel intervention and control groups. Single-blind trial was performed on 90 mothers with low birth weight infants. Randomiz.com was used for randomization.
Settings and conduct
This clinical trial study was performed for 90 mothers with low birth weight Infants who gave birth in Marand Hospital.
The present study was fulfilled using random sampling method in four blocks, consisting of 90 mothers and the samples were divided into intervention and control groups.
The study was single blind, that the researcher who filled out the depression questionnaire was blind to the study. Prior to the study, maternal depression was assessed in two groups using the Edinburgh instrument. One month after the intervention, mothers' depression was assessed in two groups with the Edinberg questionnaire. Finally, the data were analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
Mothers with low birth weight who gave birth in Marand Hospital; have a healthy infants. The following mothers were not allowed to enter the study: have severe physical illness; history of depression; use of antidepressants or other antipsychotic drugs; the baby is hospitalized or has abnormality.
Intervention groups
A home visit was conducted by the researcher for four times from the first to the fourth week after discharge. Home visits were performed for 45 minutes for the intervention group once a week.
The control group had received only the routine care of the pre-hospital ward
Main outcome variables
Edinburgh Depression Test Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201214049717N1
Registration date:2020-12-24, 1399/10/04
Registration timing:retrospective
Last update:2020-12-24, 1399/10/04
Update count:0
Registration date
2020-12-24, 1399/10/04
Registrant information
Name
zeinab fadaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4223 1905
Email address
fadaiez@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
2018-09-21, 1397/06/30
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2020-05-20, 1399/02/31
Scientific title
A comparative study of the effect of home visit versus routine care on depression in mothers with low birth weight: A clinical trial
Public title
The effect of home visit on depression in mothers with low birth weight infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a live and healthy infant with weighing 2500-1500 grams
Having access to the phone
Do not take antidepressants or other medications during pregnancy and after childbirth
No history of depression or other specific illnesses
No hearing or speech problems
Exclusion criteria:
Death or hospitalization of the infant in the NICU
Severe physical illness of the mother
Stressful events for the mother
Age
From 16 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples were assigned to two groups of intervention and control randomly blocked in quadruplets. First, the volume of each block was determined (6 blocks), then the list of blocks was determined with the help of Randomiz.com site, and the numbers one to fifteen for 90 people, and each number was placed in an envelope with its own intervention allocation list. The samples included in the study randomly selected envelopes containing numbers between one and fifteen, and the assignment of individuals to the two intervention and control groups was determined based on the list of six blocks of each number.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assess the outcome of the study was blind and had no knowledge of the study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central Building No. 2, Third Floor, Vice Chancel for Reasech, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614920
Approval date
2020-12-15, 1399/09/25
Ethics committee reference number
1393.5.4217
Health conditions studied
1
Description of health condition studied
Postpartum Depression
ICD-10 code
F53.0
ICD-10 code description
Puerperal psychosis
Primary outcomes
1
Description
Depression in mothers with low birth weight babies
Timepoint
Before the intervention; at the time of discharge from the delivery ward one month after the intervention
Method of measurement
Edinburgh Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for the intervention group, in addition to receiving routine services from health centers and receiving training during discharge, a home visit program for four times from the first to the fourth week after discharge for 45 minutes. At the time of the home visit, the educational program for the care of infants and mothers, which was prepared based on scientific sources and after confirming its validity and reliability, was approved by three professors of the Islamic Azad University of Marand and four professors of Tabriz University of Medical Sciences. During these sessions, the necessary points were taught to the mother based on the educational content provided. Educational content on the characteristics of low birth weight infants, maintaining the infant's body temperature, and how to control it and the warning signs of diseases, symptoms of neonatal jaundice, how to give medicine to the infant, umbilical cord care, infant eye care, vaccination, breastfeeding techniques Adequate or insufficient symptoms of breastfeeding, infant coverage, the space in which the infant is kept, problems with the mother's breast, bathing, and perinatal care that were taught to the mother along with postpartum care and the training package It was given to mothers.The control group received only discharge training in the hospital and routine care in health centers.
Category
Other
2
Description
Control group: the control group received only routine services from the city health centers that are provided for all mothers and also received post-discharge training in the maternity ward.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Marand Ayatollah Hojjat Kuh Kamri Hospital
Full name of responsible person
Zeinab Fadaei
Street address
Ayatollah Hojjat Kuh Kamri Hospital, Abbasi Boulevard, above Payame Noor University Marand
City
Marand
Province
East Azarbaijan
Postal code
5413945551
Phone
+98 41 4222 2451
Email
zeinab_fada@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Samad Ahdi Aghdam
Street address
Azad University of Marand, Abbasi Boulevard
City
Marand
Province
East Azarbaijan
Postal code
5413945551
Phone
+98 41 4229 2227
Email
ahdai@marandiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?