The Effect of Implementing a Positive Group Thinking Program on the Anxiety and Attachment of Mothers of Premature Infants Hospitalized in Neonatal Intensive Care Unit
Determining and comparing the anxiety and attachment of mothers of premature infants admitted to the neonatal intensive care unit before and after the intervention in the control and intervention groups
Design
A quasi-experimental clinical trial with two control and intervention groups will be performed on 72 mothers of premature infants in two separate hospitals by available sampling.
Settings and conduct
Mothers with premature infants with a gestational age of less than 37 weeks will be hospitalized in the neonatal intensive care unit of Imam Reza (AS) and Mohammad Kermanshahi hospitals in Kermanshah, which will meet the inclusion criteria in this study. Spielberger anxiety and postpartum attachment will be used between mother and baby. Then, a course of group positive thinking exercises will be prepared for the intervention group in ten one-hour sessions for ten days. In the control group, there will be routine hospital care. Upon completion of the training, post-test will be performed for both groups.
Participants/Inclusion and exclusion criteria
Mothers with premature infants less than 37 weeks gestational age admitted to neonatal intensive care unit with inclusion criteria (maternal consent to participate in the study;mothers with preterm infants less than 37weeks; neonatal hospitalization for at least10 days in the ward;not passing the same course;no chronic illness of the mother such as depression and anxiety;no history of taking sedatives and psychotropic drugs before pregnancy; no history of maternal hospitalization; not previous attending in studies in the field of positive thinking.
Intervention groups
Group positive thinking exercises will be prepared for the intervention group in ten one-hour sessions for ten days. The control group receives routine care without any intervention.
Main outcome variables
Anxiety and attachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210108049965N1
Registration date:2021-01-28, 1399/11/09
Registration timing:prospective
Last update:2021-01-28, 1399/11/09
Update count:0
Registration date
2021-01-28, 1399/11/09
Registrant information
Name
Venus Boochani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4372 3293
Email address
vboochani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Implementing a Positive Group Thinking Program on the Anxiety and Attachment of Mothers of Premature Infants Hospitalized in Neonatal Intensive Care Unit
Public title
The Effect of Implementing a Positive Group Thinking Program on the Anxiety and Attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Maternal consent to participate in the study
Mothers with premature babies less than 37 weeks
Infant hospitalization for at least 10 days in the ward
Do not pass the same course
No chronic illness of the mother such as depression and anxiety (disturbing)
No history of taking sedatives and psychotropic drugs before pregnancy (confounder)
No history of hospitalization of the mother in a mental hospital
No chronic underlying neonatal disease and abnormalities
Not previous study in the field of positive thinking (distorter)
Exclusion criteria:
Dissatisfaction with enrollment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Of Tehran University Of Medical Science
Street address
Qods Ave, Keshavarz Blv, Tehran town
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.TUMS.FNM.REC.1398.200
Health conditions studied
1
Description of health condition studied
Anxiety of mothers of premature infants in neonatal intensive care unit
ICD-10 code
P00.9
ICD-10 code description
Encounter for newborn, infant and child health examinations
2
Description of health condition studied
attachment of mothers of premature infants in neonatal intensive care unit
ICD-10 code
P00.9
ICD-10 code description
Newborn (suspected to be) affected by unspecified maternal condition
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and immediately after the end of the intervention
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
1
Description
Attachment
Timepoint
Before the intervention and immediately after the end of the intervention
Method of measurement
Maternal Postnatal Attachment Scale(MPAS)
Intervention groups
1
Description
Intervention group: Includes 36 peopleOne of the mothers of premature infants is hospitalized who, after obtaining informed consent, enter an intervention to receive positive thinking training by a facilitator and a psychologist.The training will be based on Seligman's book on positive thinking and will be given to mothers in ten one-hour sessions for ten days.
Category
Behavior
2
Description
Control group: Includes 36 mothers of premature infants hospitalized who enter the study in an available manner and after obtaining informed consent. This group receives routine care without any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Venus boochani
Street address
Parastar Blvd., Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6715936465
Phone
+98 83 3427 6301
Email
Vboochani@gmail.com
2
Recruitment center
Name of recruitment center
Mohamad Kermanshahi Hospital
Full name of responsible person
Venus boochani
Street address
Helal Ahmar Intersection, Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6715934465
Phone
+98 83 3721 8202
Email
vboochani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Geranmaye
Street address
Tohid Square, East Nusrat Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
fnm@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Venus Boochani
Position
Master Of Neonatal Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran School of Nursing, Midwifery, Dr. Mirkhani Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Fax
Email
vboochani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Venus Boochani
Position
Master Of Neonatal Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran School of Nursing, Midwifery, Dr. Mirkhani Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Fax
Email
vboochani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Venus Boochani
Position
Master Of Neonatal Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran School of Nursing, Midwifery, Dr. Mirkhani Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Fax
Email
vboochani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the request of intervention groups
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