Protocol summary

Study aim
Determining the effect of emotion regulation training based on the Gross model on mothers' rumination and bonding with premature babies admitted to the neonatal intensive care unit in the gorgan teaching hospitals in 1403
Design
Among the mothers of premature babies hospitalized in the neonatal intensive care unit who had the conditions to participate in the study, 60 people were selected by non-probability sampling in a simple random manner. Random allocation was also done using the table of random numbers, in such a way that odd numbers were placed in the control group (30 people) and even numbers were placed in the test group (30 people).
Settings and conduct
classic experimental research. the demographic information form that includes information about the mother and information about the baby complete after the baby will be admitted After that, the rumination questionnaire of Nolen and Maru (1989) and the questionnaire for assessing mother-infant bond after delivery by Brockington et al. (2006) are distributed by both test and control groups under the same conditions in the pre, then the educational program will be implemented in the test group by the researcher during 8 sessions of 90 minutes per day face to face and individually.
Participants/Inclusion and exclusion criteria
literacy age at least18 for mother Gestational age less than 37 weeks neonate must not be twins Hospitalization of the baby according to the doctor's order for at least 8 days Willingness to participate in the study No history of abnormal or premature birth in the mother Non-use of drugs by the mother The absence of the baby from certain congenital diseases, including heart disease and severe syndromes
Intervention groups
All mothers of premature babies hospitalized in the intensive care unit
Main outcome variables
Rumination of the mother of a premature baby bonding the mother with a premature baby

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240617062154N1
Registration date: 2024-06-26, 1403/04/06
Registration timing: registered_while_recruiting

Last update: 2024-06-26, 1403/04/06
Update count: 0
Registration date
2024-06-26, 1403/04/06
Registrant information
Name
negar shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3233 2734
Email address
ngrshafieii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of emotion regulation training based on the Grass method on mothers' rumination and bonding with preterm infants hospitalized in the neonatal intensive care unit in
Public title
effect of emotion regulation training based on the Grass method on mothers' rumination and bonding with preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having the premature infant who hospitalized in neonatal intensive care unit Hospitalization of the baby according to the doctor's order for at least 8 days literacy the neonate must not be twins Gestational age less than 37 weeks Willingness to participate in the study
Exclusion criteria:
Not having a history of abnormal or premature birth in the mother mother has not to be drug users The absence of the baby from a specific congenital disease, including heart disease and severe syndromes
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)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
aryana building/shahrivar street/edalat 28 av
City
Gorgan
Province
Golestan
Postal code
4916616469
Approval date
2024-04-30, 1403/02/11
Ethics committee reference number
IR.GOUMS.REC.1403.083

Health conditions studied

1

Description of health condition studied
effect of emotion regulation training based on the Grass method on mothers' rumination and bonding with preterm infants hospitalized in the neonatal intensive care unit
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Rumination of mothers of premature babies-the bonding of mothers and infant
Timepoint
Before the start of the intervention - after the completion of the intervention
Method of measurement
Rumination Questionnaire of Nolen and Maru (1989) - Maternal and Infant Bonding Questionnaire of Brockington et al. (2006)

Secondary outcomes

1

Description
Rumination score
Timepoint
Before starting the intervention_ after ending the intervention
Method of measurement
Nolen Hoeksma and Maro's 22-item questionnaire

2

Description
Mother and baby bond
Timepoint
Before starting the intervention_ after ending the intervention
Method of measurement
Brockington's 25-question mother-infant bonding questionnaire

Intervention groups

1

Description
Intervention group: Mothers of hospitalized premature babies
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
neonatal intensive care unit in taleghani hospital
Full name of responsible person
Negar shafiei
Street address
taleghani hospital.janbazan blv
City
Gorgan
Province
Golestan
Postal code
4916668198
Phone
+98 17 3222 7720
Fax
+98 17 3224 8070
Email
taleghanilib@goums.ac.ir

2

Recruitment center
Name of recruitment center
neonatal intensive care unit in sayad shirazi hospital
Full name of responsible person
negar shafiei
Street address
sayad shirazi hospital,shahid sayad shirazi.blv
City
gorgan
Province
Golestan
Postal code
49178677439
Phone
+98 17 3225 1502
Fax
+98 17 3225 1290
Email
Sayyadlib@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
negar shafiei
Street address
azad university of aliabad katul . university blv
City
aliabad katool
Province
Golestan
Postal code
9345149417
Phone
+98 17 3422 2300
Fax
+98 17 3422 5673
Email
info@aliabadiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
private
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
nafiseh hekmatipur
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
azad university . university blv
City
aliabadkatool
Province
Golestan
Postal code
9345149417
Phone
+98 17 3422 2300
Fax
+98 17 3422 5673
Email
n_kekmati68@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nafiseh hekmatipur
Position
Professeur assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Azad university of Aliabad katul, university Blv
City
Aliabad katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
n_hekmati68@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Negar shafiei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Aryana building. Sharivar markazi St.edalat 28
City
Gorgan
Province
Golestan
Postal code
4916616469
Phone
+98 17 3233 2734
Email
Ngrshafieii@gmail.com

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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