The Effect of Supportive-Educational Intervention Based on Orem's Self-care Model on The Psychological Well-being of Mothers with Premature Newborn Hospitalized in The Neonatal Intensive Care Unit
Investigating the impact of using the Orem model on the psychological well-being of mothers with babies hospitalized in the NICU
Design
The clinical trial has a control group and an intervention group, a blind strain, randomized, on 50 people, the method of assigning people to the groups under study will be using the random block method.
Settings and conduct
Mothers with babies hospitalized in the NICU of Taleghani hospital in Arak . Demographic information questionnaire of mother and baby and Reef psychological well-being questionnaire are completed by mothers of two groups. a needs assessment is performed on the mothers of the intervention group. Then, based on the needs of the mothers, educational-support sessions are planned and implemented individually for the mothers. Meetings will be held for a maximum of 4 sessions and for 60-90 minutes. Mothers in the intervention group will be followed up by the researcher for one month after the last session. Then, at the end of one month, Reef's psychological well-being questionnaire is compared and analyzed by two control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Not having a history of mother's mental illness؛
Hospitalization of the baby in the NICU؛
Absence of congenital abnormalities in the baby؛
Gestation age 28-36 weeks
Intervention groups
Intervention group: holding individual meetings in the unit training room
Control group: receiving routine training in the NICU
Main outcome variables
Psychological Well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240507061702N1
Registration date:2024-05-26, 1403/03/06
Registration timing:prospective
Last update:2024-05-26, 1403/03/06
Update count:0
Registration date
2024-05-26, 1403/03/06
Registrant information
Name
Sara Komeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3383 8268
Email address
sarakomeili1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Supportive-Educational Intervention Based on Orem's Self-care Model on The Psychological Well-being of Mothers with Premature Newborn Hospitalized in The Neonatal Intensive Care Unit
Public title
The Effect of Supportive-Educational Intervention Based on Orem's Self-care Model on The Psychological Well-being of Mothers with Premature Newborn Hospitalized in The Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being literate in reading and writing
Willingness to participate in the study
Not having a history of mother's mental illness
Procreation
No history of infertility
No history of stillbirth
Hospitalization of the baby in the NICU department
Absence of congenital abnormality in the baby
Gestational age 28-36 weeks
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning people to the groups under study will be random block method. For this purpose, four possible blocks containing two cases of the intervention group and two cases of the control group are divided, and then these blocks of four are numbered sequentially from one, and using the table of random numbers, those codes are selected and the process of assigning people to each One of the groups will be based on the order of that code selected from the table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person who is the data analyst is unaware of the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
University of Medical Sciences., Basij Square
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2024-04-14, 1403/01/26
Ethics committee reference number
IR.ARAKMU.REC.1403.015
Health conditions studied
1
Description of health condition studied
Psychological well-being
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Psychological well-being
Timepoint
The first stage at the beginning of the study and the second stage one month after the intervention
Method of measurement
Reef psychological well-being questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The purpose of the research is explained to the mother before starting the study. Then the informed consent form, demographic and psychological well-being questionnaire will be completed by the mother. In the intervention group, a supportive-educational program based on Orem's self-care model is implemented. This intervention is organized in 5 stages in the form of a nursing system and educational-support program, in the form of face-to-face and individual meetings for 60-90 minutes with mothers in the teaching room of the ward and is carried out as follows. The first stage: using questions and The answers and views of the mothers, as well as a review of the texts of their needs in the field of self-care and baby care, show that the first face-to-face meeting is in accordance with this stage.The second stage: based on the findings of the previous stage, the training components in this session include: emotional support, as well as offering strategies to control anxiety and perform relaxation techniques (breathing exercises), postpartum care, maternal nutrition, and postpartum fatigue to mothers. Breast fissure is the answer to the questions that the second face-to-face meeting corresponds to this stage. The third stage: The training components in this session include emotional support, pelvic floor muscle exercises, urinary stress incontinence, breastfeeding, bathing the baby, diapering the baby, answering questions, and the third face-to-face session corresponds to this stage.The fourth stage: the training components in this session include emotional support, colic, hug care, baby massage, baby bath, training during discharge, answering questions, the fourth face-to-face session corresponds to this stage. It should be noted that all the components As mentioned, mothers are taught, but more emphasis is placed on the topics needed by each mother according to the needs assessment. Also, the trainings that will be conducted in this research based on the Orem model are different from the trainings that are usually given by nurses in the neonatal intensive care unit. In this research, trainings are conducted for the intervention group based on the criteria of deviation from health in the mother.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital, Arak
Full name of responsible person
Sara Komeili
Street address
Imam Khomeini St.
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 4001
Email
It-taleghani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Samaneh Kaveie
Street address
University of Medical Sciences, University Complex of the Prophet (PBUH), Vice President of Research and Technology
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3383 8320
Email
kaveh20288@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Sara Komeili
Position
Master of Science in Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing., University of Medical Sciences., Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3383 8268
Fax
Email
sarakomeili1999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sara Komeili
Position
Master of Science in Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing., University of Medical Sciences., Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Fax
Email
sarakomeili1999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sara Komeili
Position
Master of Science in Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing., University of Medical Sciences., Basij Square
City
Arak
Province
Khouzestan
Postal code
3848176941
Phone
+98 86 3417 3524
Fax
Email
sarakomeili1999@gmail.com
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
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
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Access is open to the public.
Under which criteria data/document could be used
Access is open to the public.
From where data/document is obtainable
The main researcher
What processes are involved for a request to access data/document