Effect of midwifery led psycho-education in distress, postnatal depression,parental eligibility of women with high risk pregnancy that referred to Kamali hospital 1396-1397
Determining the Effect of midwifery led psycho-education in distress, postnatal depression,parental eligibility of women with high risk pregnancy
Design
Clinical trials with a control group, community based and pragmatic, with parallel,Not blind , randomized groups
Settings and conduct
After obtaining informed consent of participants samples based on quarterly block randomization will be divided into two intervention and control groups. In This study blinding is impossible
Participants/Inclusion and exclusion criteria
nulliparous
with diagnosed of high risk pregnancy
gestational age 34 weeks or more
access on phone
out go scale: having psychologic disorder or on treatment with psychologist expert and history of hospitalization on psychiatry or tretment by sedative
having child with mental or physical malformation
reject phone call for pursuit training
not participate on one training class
Intervention groups
the intervantion group will receive midwifery led psycho-education about increasing parental eligibility,reducing parental distress and preventing postnatal depression.the contro group will receive routine care.
Main outcome variables
distress، postnatal depression,parental eligibility of women with high risk pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020719N10
Registration date:2018-09-01, 1397/06/10
Registration timing:registered_while_recruiting
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Sara Esmaelzadeh Saeieh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
s-esmaelzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-13, 1397/02/23
Expected recruitment end date
2018-09-14, 1397/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of midwifery led psycho-education in distress, postnatal depression,parental eligibility of women with high risk pregnancy that referred to Kamali hospital 1396-1397
Public title
The Effect of led psycho-education in distress, postnatal depression,parental eligibility of women with high risk pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
nulliparous
with diagnosed of high risk pregnancy
admit at least one week on perinatal section at kamali hospital
gestational age 34 weeks or more
At least the reading and writing skills
Iranian nationality
have a satisfaction on research participation
access on phone
Exclusion criteria:
having psychologic disorder or on treatment with psychologist expert and history of hospitalization on psychiatry or tretment by sedative
having child with mental or physical malformation
mothers with child under 34 weeks
reject phone call for pursuit training
not have a satisfaction on research participation
not participate on one training class
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
Use the quadruple random block
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 Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, Azimieh, Alborz, Iran
City
Alborz
Province
Alborz
Postal code
3186947535
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
Abzums.Rec.1396.215
Health conditions studied
1
Description of health condition studied
postpartum depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioral disorders associated with puerperium, not elsewhere classified
2
Description of health condition studied
parenthood stress
ICD-10 code
53.8
ICD-10 code description
Mild mental and behavioral disorders associated with puerperium, not elsewhere classified
Primary outcomes
1
Description
distress
Timepoint
Before intervention, After intervention and one month after delivery
Method of measurement
distress Questionnaire
2
Description
postnatal depression
Timepoint
Before intervention, After intervention and one month after delivery
Method of measurement
edinburgh postnatal depression scale
3
Description
parental eligibility
Timepoint
Before intervention, After intervention and one month after delivery
Method of measurement
parental eligibility Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group consists of nuliparous women with high-risk pregnancy diagnosis and gestational age of 34 week and more,who are hospitalised in prenatal section in kamali hispital.intervention group will receive midwifery led psycho_education about increasing parental eligibility,reducing parental distress and preventing postnatal depression.Midwifery led psycho_education,is a brief counseling education provided by a midwife and 4 sessions.contents of these session is as follows:First session lasts 60-90 minutes and is attended as group and in person during hispitalisation in high-risk pregnant women section.In this session,the goals of the study are explained and some information about infant necessary cares,how child is growing,childs gender and postnatal depression signs is provided.In the end,information about strategies for mothers to face with stress is provided.Second session is also while being hospitalised in high_risk pregnant women section,immediately after first session is done,and lasts for 60-90 minutes.In this session, information about extending and improving social support,identifying and confronting personal conflicts hs provided,and problem solving skills and skills to improve relationship with spouse after the birth of the newborn child is educated.In the end,this session includes respiratory techniques postnatal exercises,mind focus and stress reduction trainings.Third session is right after childbirth,and is attended as personal training.In this sessions before is reviewed,and respiratory techniques,postnatal exercises,mind focous and stress reduction approaches are practised,and how to make use of other mothers experiences and problems the patient has had after childbirth is spoken.Forth session is done,as personal training trough phone call, in one month after childbirth.in this session,educations provided are followed, suggestions about problems faced with after childbirth is offered,worries associated with maternal role is spoken and family support is emphasised.