This study is a clinical trial. The aim of this study is to compare the effect of direct and indirect counselling on family stress and Anxiety in delivery of nulliparous pregnant women. Families’ nulliparous pregnant women (spouse of pregnant women and /or the person who is responsible for the care of pregnant women during labor and after it. this person could be mother or mother-in-law or sister or sister-in-law of pregnant women) make the studies population. Samples were refered to 17 Shahrivar Maternity and Shahid Chamran hospital center and obstetrics clinics for prenatal care .they are elected with Using random permutation blocks and are placed in intervention and control groups. This study is not blinded. At the beginning of the third trimester of pregnancy Cohen perceived Stress Scale (PSS-14) and Cattell Anxiety Scale are filled out by families. Then six sessions of group cognitive counselling held weekly intended to create knowledge and to increase awareness on delivery issues, for one group. Tele-counseling with some training material in written form is offered for the second group, and there is no intervention for control group. Questionnaires are completed by all three groups once again by the time when pregnant mothers go for delivery and these questionnaires are compared with the previous ones. Each group consists of 36 families, so sample size totally equals 108 families. Inclusion criteria: first pregnancy and singleton; participants of the counselling sessions must be the main caregiver and the only responsible person of pregnant women during pregnancy, delivery and postpartum period; all of the participants in this study must not suffer from any kinds of physical diseases, mental disorders or depression and also they must not experience drug abuse (via asking in demographic form); pregnant women and participants of the counselling sessions must not attend such training classes on delivery preparation. exclusion criteria: Preterm delivery of pregnant mothers before the end of counselling sessions; pregnancy complications in pregnant women including preeclampsia, placental abruption, gestational diabetes and any other events that is considered as an indication for high risk pregnancy; Two or more missed absent sessions for participants; being elected for caesarean; Absence of participants at the time of delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071428924N1
Registration date:2016-10-01, 1395/07/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-01, 1395/07/10
Registrant information
Name
Mozhgan Khalili
Name of organization / entity
School of Nursing and Midwifery Kermanshah, Science committee
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 8588
Email address
mozhgankhalili@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kermanshah University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing two model of counseling (direct and indirect) on family stress and Anxiety in delivery of nulliparous pregnant women
Public title
Effect of counseling on family stress and anxiety.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous pregnant women, have singleton pregnancies; Cases without high risk pregnancy criteria; Participants must be the main caregiver and only responsible individual for the pregnant woman during her pregnancy and postpartum period; The pregnant women must deliberately decide to deliver their babies in health centers of Saveh city; They must not be mournful during the last three months; The pregnant women and the participants must not have any physical diseases, surgery, mental disorders and depression (via asking in demographic form); The pregnant women and the participants must not have any drug abuse and addiction (via asking in demographic form); They must be fluent in Persian; The pregnant women and their participants must not have any previous training experiences about delivery; There is no history of maternal death in the family; The health staffs must not be presented in these families.
Exclusion criteria: Preterm delivery of pregnant mothers before the end of counselling sessions; pregnancy complications in pregnant women including preeclampsia, placental abruption, gestational diabetes and any other events that is considered as an indication for high risk pregnancies; Two or more absent sessions for participants; Being elected for caesarean; Absence of other participants at the time of delivery.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
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
Ethics committee Kermanshah University of Medical Sciences
Street address
Central Building Kermanshah University of Medical Science, shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
6715847141
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
KUMS.REC.1395.174
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
R46.6
ICD-10 code description
undue concern and preoccupation with stressful events
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances
Primary outcomes
1
Description
Stress
Timepoint
Before intervention and Three months after the intervention
Method of measurement
Cohen perceived Stress Scale (PSS-14)
2
Description
Anxiety
Timepoint
Before intervention and Three months after the intervention
Method of measurement
Cattell Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 2: Some training material with telephone counselling.
Category
Lifestyle
2
Description
Intervention 1: six sessions of group cognitive counselling were held weekly intended to create knowledge and to increase awareness on delivery issues, for one group
Category
Lifestyle
3
Description
Control group: Do not cause any interference.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Fariba Alaem
Street address
Saveh Social Security Hospital
City
Saveh
2
Recruitment center
Name of recruitment center
17 Shahrivar Maternity
Full name of responsible person
Fariba Alaem
Street address
17 Shahrivar hospital,Saveh
City
Saveh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor Of Research Kermanshah University of Medical Sciences
Full name of responsible person
Kurosh Hamzehi
Street address
Building Kermanshah University of Medical Science, Kermanshah, shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor Of Research Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fariba Alaem
Position
Post Graduate Student in Midwifery Advice
Other areas of specialty/work
Street address
School of Nursing and Midwifery Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3827 8588
Fax
Email
fariba.alaem@yahoo; comfac_n.m@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mozhgan Khalili
Position
Post Graduate
Other areas of specialty/work
Street address
School of Nursing and Midwifery Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3827 8588
Fax
Email
fac_n.m@kums.ac.ir; khalily1267@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Mozhgan Khalili,
Position
Post Graduate, Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3827 8588
Fax
Email
fac_n.m@kums.ac.ir; khalily1267@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)