To determine the effect of supportive counseling on mental health in premature infants' mothers.
Design
Randomized controlled trial with two parallel arms.
Settings and conduct
This study will be conducted on 66 mothers with premature infants who have been admitted to the infant's intensive care unit of Al-Zahra hospital. The researcher will refer to hospital and will select women who have been given birth between the week 28 to 33 weeks and 6 days, and they will be invited to participate in the study. Then the Mental Health Questionnaire (MHQ) will be completed by mothers. Individuals who have received a score of less than 24 according to MHQ will be included in the study and written consent will be obtained. Then, the other questionnaires including the socio-demographic information and the postpartum bonding questionnaire will be completed. The researcher will record the weight, height and head circumference of the infant into the anthropometric indices checklist. Participants will be randomly assigned into two groups of counseling and control. Participants will be followed up 8 weeks after childbirth and MHQ will be completed.
Participants/Inclusion and exclusion criteria
Participants will be women who have been given birth between the week 28 and 33 weeks and 6 days and their babies have been admitted to the NICU.
Intervention groups
The intervention group will receive supportive counseling and control group will receive routine care.
Main outcome variables
The main outcome variable is mental health who will be measured by MHQ in the first 72 hours and at 8 weeks postpartum.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N46
Registration date:2018-10-29, 1397/08/07
Registration timing:registered_while_recruiting
Last update:2018-10-29, 1397/08/07
Update count:0
Registration date
2018-10-29, 1397/08/07
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-26, 1397/08/04
Expected recruitment end date
2019-03-25, 1398/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive counseling on the mothers’ mental health of premature newborns: a randomised controlled trial
Public title
The effect of supportive counseling on the mothers’ mental health of premature newborns
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least secondary education
Babies who borned between 28 to 33 weeks and 6 days and hospitalized in NICU
Having a phone number to follow-up
Resident of Tabriz city
Nulliparous mothers
Mothers who delivered less than 72 hours
Exclusion criteria:
Uncertainty about being able to attend all consultation sessions.
Use of psychoactive drugs and antidepressants, history of pre-pregnancy psychiatric problems based on the participant's statement.
Existence of any congenital anomaly in the baby
Mothers who will be hospitalized for more than 72 hours.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted using the website www.random.org and through blocking with block sizes of four and six (Stratification based on the gestational age of 28-30 weeks and 6 days and 31 to 33 weeks and 6 days) and an allocation ratio of 1: 1 to the two groups of counseling and control.
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-10-15, 1397/07/23
Ethics committee reference number
IR.TBZMED.REC.1397.593
Health conditions studied
1
Description of health condition studied
Mental health
ICD-10 code
Z00.4
ICD-10 code description
General psychiatric examination, not elsewhere classified
Primary outcomes
1
Description
Mental health of mothers
Timepoint
Preintervention in the first 72 hours after delivery, Postintervention in 8 weeks after childbirth
Method of measurement
Mental Health Questionnaire
Secondary outcomes
1
Description
Postpartum bonding
Timepoint
Preintervention in the first 72 hours after delivery, postintervention in 8 weeks after childbirth
Method of measurement
Postpartum Bonding Questionnaire
2
Description
Anthropometric indices of infants
Timepoint
Preintervention in the first 72 hours after delivery, postintervention in 8 weeks after childbirth
Method of measurement
Preintervention based on the infants file, postintervention measured by the researcher
Intervention groups
1
Description
Intervention group: For the intervention group, supportive counseling will be provided during six 45-60 minutes sessions.
Category
Prevention
2
Description
Control group: The control group will be received routine care.