Protocol summary

Study aim
To assess the effect of counseling with empowerment approach on stress and self-esteem of mothers with premature neonates
Design
This is a randomized clinical trial, in which 80 eligible mothers will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible mothers with premature neonates referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 40 years, Stability of the hemodynamic status of the neonate, Singleton, First pregnancy, Wanted pregnancy, Low self-esteem (score less than 30 using the Rosenberg scale), Having stress (score above 46 using the Parental Stress Scale), Living together with her husband, Literate, Persian language, A resident of Hamadan city, Exclusion criteria: Mental disorder
Intervention groups
Intervention group: Routine treatment and care for neonates plus counseling with empowerment approach to the mother in 4 sessions, 2 sessions per week, face to face, including how to care for the baby, the baby's needs, the continuous positive communication between mother and baby, the baby's moods and behaviors, emotional communication with the baby, stress reduction methods between mother and baby, and age-appropriate games Control group: Routine treatment and care for neonates
Main outcome variables
Stress, self-esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N369
Registration date: 2020-09-28, 1399/07/07
Registration timing: prospective

Last update: 2020-09-28, 1399/07/07
Update count: 0
Registration date
2020-09-28, 1399/07/07
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
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling with empowerment approach on stress and self-esteem of mothers with premature neonates: a randomized clinical trial
Public title
Effect of counseling with empowerment approach on stress and self-esteem of mothers with premature neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years, Stability of the hemodynamic status of the neonate, Singleton, First pregnancy, Wanted pregnancy, Low self-esteem (score less than 30 using the Rosenberg scale), Having stress (score above 46 using the Parental Stress Scale), Living together with her husband, Literate, Persian language, Resident of Hamadan city,
Exclusion criteria:
Mental disorder
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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
2020-08-22, 1399/06/01
Ethics committee reference number
IR.UMSHA.REC.1399.475

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

Primary outcomes

1

Description
Stress
Timepoint
Before the intervention and 2 weeks later
Method of measurement
Using the Parental Stress Scale (PSS)

2

Description
Self-esteem
Timepoint
Before the intervention and 2 weeks later
Method of measurement
Using the Rosenberg self-esteem questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine treatment and care for neonates plus counseling with empowerment approach to the mother in 4 sessions, 2 sessions per week, face to face, including how to care for the baby, the baby's needs, the continuous positive communication between mother and baby, the baby's moods and behaviors, emotional communication with the baby, stress reduction methods between mother and baby, and age-appropriate games
Category
Treatment - Other

2

Description
Control group: Routine treatment and care for neonates
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Marzieh Karimi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
marziekarimi81@yahoo.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
Marzieh Karimi
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
marziekarimi81@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mansoureh Refaei
Position
Reproductive Health Specialist
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
mansourehrefaei@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
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