To determine the effect of problem solving skills on coping styles and emotional self-efficacy in preterm infants.
Special purpose: 1- Determining the effect of problem solving skills on problem-focused coping styles in mothers of preterm infants; 2- Determining the effect of problem solving skills on emotion-focused stress coping styles in mothers of preterm infants; 3- Determine the effect of problem solving skills on emotional self-efficacy in mothers of preterm infants.
Design
A clinical trial, with control group and intervention, randomized based on time block, available method, 60 mothers hospitalized infants
Settings and conduct
The research units were randomly assigned to 4 teaching hospitals of Mashhad (Imam Reza-A-, Ghaem-Aj-, Umol-Banin-S- and Hashemi Nejad) in a randomized allocation method at least 48 hours after birth. Subjects were divided into 3 to 5 groups for 6 sessions of at least 60 minutes three times a week training in problem solving skills by the Dezurilla and Gold Fried method. 2 weeks later and one month after step 2 the tools will be filled.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infant age less than 32 weeks; no maternal well-known chronic physical and mental illness; minimum level of maternal education at primary level; mother 18 years and over; no history of preterm birth in previous maternal deliveries; lack of any malformations congenital major in infant. Exclusion criteria: mother's withdrawal from continuing study, infant death, infant discharge before intervention, and absence of more than one session in intervention sessions.
Intervention groups
Control: receiving routine care. Intervention: in addition to routine care, they receive problem solving skills.
Main outcome variables
Coping styles of stress; emotional self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191211045696N1
Registration date:2020-01-13, 1398/10/23
Registration timing:registered_while_recruiting
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
Mahbobe Bagheri maraghe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3623 3706
Email address
bagherimm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of problem solving skills on stress coping styles and emotional self-efficacy in mothers of premature infants
Public title
The effect of problem solving skills on stress coping styles and emotional self-efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with premature infants babies less than 32 weeks of gestation
The mother has no known chronic physical or mental illness
The minimum level of education for mothers is at the elementary level
The mother is 18 years of age or older
Lack of birth record of premature infan in previous maternity
Lack of any congenital major malformations in the infants
At least 48 hours have passed since the infant birth
Exclusion criteria:
Maternal withdrawal from continuing study
Mother's absence is more than one session in intervention sessions
The infant is discharged before the intervention is completed
Death is the infants
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sample size will be divided into control and intervention groups by random allocation method (based on time blocks).
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 research of Mashhad School of Nursing and Midwifery
Street address
Four ways doctorate
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.068
Health conditions studied
1
Description of health condition studied
Stress Coping Styles
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Emotional self-efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress Coping Styles
Timepoint
Before - two weeks later - a month later
Method of measurement
Lazarus Coping Questionnaire
2
Description
Emotional self-efficacy
Timepoint
Before - two weeks later - a month later
Method of measurement
Emotional Self-efficacy Questionnaire-ESES
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine care, they receive problem solving skills for 6 sessions at least 60 minutes 3 times a week using the Dezurilla & Gold Fried method in groups of 3-5 .
Category
Behavior
2
Description
Control group: receive only routine care. After completing the task, the control group will be trained on how to apply problem solving skills.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Dr. Monir Ramezani
Street address
Taqi Abad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
ramezanimn@mums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Monir Ramezani
Street address
Four ways doctor
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
ramezanimn@mums.ac.ir
Web page address
3
Recruitment center
Name of recruitment center
Amolbanin Hospital
Full name of responsible person
Dr. Monir Ramezani
Street address
Zarineh Intersection - Corner of Ayatollah Behjat 16
The first three floors south, University 15, University street, Imam Khomeini street
City
Shirvan
Province
North Khorasan
Postal code
9461987634
Phone
+98 58 3623 3706
Email
bagherimm951@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahboubeh Bagheri Maragheh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The first three floors south, University 15, University street, Imam Khomeini street
City
Shirvan
Province
North Khorasan
Postal code
9461987634
Phone
+98 58 3623 3706
Email
bagherimm951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboubeh Bagheri Maragheh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The first three floors south, University 15, University street, Imam Khomeini street
City
Shirvan
Province
North Khorasan
Postal code
9461987634
Phone
+98 58 3623 3706
Email
bagherimm951@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboubeh Bagheri Maragheh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The first three floors south, University 15, University street, Imam Khomeini street
City
Shirvan
Province
North Khorasan
Postal code
9461987634
Phone
+98 58 3623 3706
Email
bagherimm951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
When the data will become available and for how long
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
To whom data/document is available
Scholars working in academic and scientific institutions and students
Under which criteria data/document could be used
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
From where data/document is obtainable
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
What processes are involved for a request to access data/document
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.