Investigating the effect of Solution-Focused Brief Therapy (SFBT) on Psychological Well-being and Psychological distress of mothers with Prermature Neonates hospitalized in Neonatal Intensive Care Unit (NICU)
Determining the effect of Solution-Focused Brief Therapy (SFBT) on Psychological well-being and
Psychological distress of mothers with Prermature Neonates hospitalized in Neonatal Intensive Care
Unit (NICU) of Afzalipour hospital, Kerman, Iran, 2020.
Design
The present study is a quasi-experimental study of clinical trial type with intervention and control group and pre-test and post-test. The sample size was 60( 30 in the intervention group and 30 in the control group) of mothers with Prermature Neonates hospitalized in Neonatal Intensive Care
Unit (NICU) of Afzalipour hospital in Kerman city.An available sampling method is used. At the beginning of the study, they are randomly divided into two groups (one intervention group and one control group).
Settings and conduct
The implementation area is the consultation in the midwifery room of Afzalipour hospital. The mentioned consultation will be done for the intervention group and a summary of the interventions and counseling is provided orally or educational CD for the control group after completing the post-test questionnaire. Data collection was performed by questionnaires immediately after the intervention and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion: Premature birth (under 37 weeks)
Willingness to participate in the study
Exclusion: Lack of willingness and cooperation of mothers to complete the questionnaire and not attending training sessions (maximum of two consecutive sessions)
Intervention groups
Intervention is used to Solution-Focused Brief Therapy is conducted twice a week for 90 minutes for 2 weeks in the intervention group.
Main outcome variables
Psychological well-being
Psychological distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048234N1
Registration date:2020-09-07, 1399/06/17
Registration timing:prospective
Last update:2020-09-07, 1399/06/17
Update count:0
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Fatemeh Hassanshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3743 5964
Email address
fatemehhassanshahi1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Solution-Focused Brief Therapy (SFBT) on Psychological Well-being and Psychological distress of mothers with Prermature Neonates hospitalized in Neonatal Intensive Care Unit (NICU)
Public title
Investigating the effect of Solution-Focused Brief Therapy on Psychological Well-being and Psychological distress of mothers with Prermature Neonates hospitalized in Neonatal Intensive Care Unit
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Premature birth (under 37 weeks)
Absence of obvious abnormalities or genetic disorders (gastrointestinal, cardiac, urinary, neurological abnormalities and trisomies 13,18,21)
No history of anxiety disorders and depression
Literate and fluent in Persian
Exclusion criteria:
Attending another intervention or study while participating in this study
Lack of willingness and cooperation of mothers to complete the questionnaire and not attending training sessions
Occurrence of anxious events while studying
Maternal addiction
Transfer the baby to other medical centers
Infant death
Care by family members other than the mother
Age
No age limit
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
How to randomize will be through random table. To use the random number table, each sample is given a code or machine number, the researcher randomly starts from a table point in a row or column, selecting the point by blindfolding and placing finger or pen tip on the table. Moves in the direction of a row or column.
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 Kerman University of Medical sciences
Street address
Fourth unit, second floor, Farhad building, Alley 25, Paeiz street
City
Shiraz
Province
Fars
Postal code
7177933354
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.KMU.REC.1399.049
Health conditions studied
1
Description of health condition studied
Psychological well-being
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Psychological distress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Psychological well-being score in the Ryff Scale
Timepoint
Before intervention and after the sessions are completed and one month after the intervention
Method of measurement
Ryff Psychological Well-Being Scale
2
Description
Psychological distress score in the Depression, Anxiety and Stress Scale(21-DASS)
Timepoint
Before intervention and after the sessions are completed and one month after the intervention
Method of measurement
The Depression, Anxiety and Stress Scale - 21 Itemes(21-DASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The method of this research is quasi-experimental and the research design is pre-test-post-test with a control group that will be performed on 60 mothers with infants admitted to the neonatal intensive care unit. For the mothers of the intervention group, after determining the score of psychological distress and psychological well-being using DASS and Ryff questionnaires, 4 sessions of Solution-Focused Brief Therapy will be held for 90 minutes and 2 times a week.(Solution-Focused Brief therapy is one of the effective and short-term counseling models that has a non-cognitive perspective on clients and helps clients find solutions to their current problems).
Category
Lifestyle
2
Description
Control group: They don't receive any intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Fatemeh Hassanshahi
Street address
Fourth unit, Second floor, Farhad building, Alley 25, Paeiz street
City
Shiraz
Province
Fars
Postal code
7177933354
Phone
+98 71 3743 5964
Email
fatemehhassanshahi7374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Fourth unit, Second floor, Farhad building, Alley 25, Paeiz street
City
Shiraz
Province
Fars
Postal code
7177933354
Phone
+98 71 3743 5964
Email
fatemehhassanshahi7374@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassanshahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fourth unit, Second floor, Farhad building, Alley 25, Paeiz street
City
Shiraz
Province
Fars
Postal code
7177933354
Phone
+98 71 3743 5964
Email
fatemehhassanshahi7374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassanshahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fourth unit, second floor,Farhad building,alley 25,Paeiz st
City
Shiraz
Province
Fars
Postal code
7177933354
Phone
+98 71 3743 5964
Fax
Email
fatemehhassanshahi7374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassanshahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fourth unit, second floor,Farhad building,alley 25,Paeiz st
City
Shiraz
Province
Fars
Postal code
7177933354
Phone
+98 71 3743 5964
Fax
Email
fatemehhassanshahi1374@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Data on the main outcomes of the research after the completion of research work can be published.
When the data will become available and for how long
Starting access to the data above is immediately after publishing the results.
To whom data/document is available
Researchers in academia and scientific institute are able to access research data.
Under which criteria data/document could be used
In case of supplementary research, using data is permitted.
From where data/document is obtainable
The applicant can contact the researcher to receive information via email.
nasim.shahrahmani@gmail.com fatemehhassanshahi7374@gmail.com
What processes are involved for a request to access data/document
After submitting a written request from the applicant, the data will be provided to him/her as soon as possible.