The effect of a Mindfulness-Based Stress Reduction (MBSR) Program on Coping Behaviors, and Attachment of Mothers of Neonates with Congenital Diseases in the selected hospitals affiliated to Shahid Beheshti University of Medical Sciences. 2019.
General purpose
Determining the effect of "Mindfulness-based stress reduction" program on "Coping Behaviors" and "Attachment" of mothers of infants with congenital disease in selected hospitals of Shahid Beheshti University of Medical Sciences.
Design
Clinical trial with control and intervention group, randomized, in parallel.
Settings and conduct
Referring to the Mofid and Mahdieh hospitals for four weeks once a week, then randomly selecting the control and intervention groups and then training the intervention period of 45-120 minutes.
Participants/Inclusion and exclusion criteria
Entry criteria: 1. The mother has the ability to read and write. 2. The mother has the ability to speak Persian. 3. Infant under one week of infantile congenital anemia that does not lead to a baby's death based on prediction and diagnosis. 4. The mother has no mental illness or anxiety disorders based on the documentation of the case. 5. The mother has no previous experience of having another child with congenital malformation, according to her mother's case and file documentation. Non-compliance criteria: 1. The probability of a baby's impending death is based on clinical evidence and medical documentation. 2. The mother does not want to participate in the research.
Intervention groups
Mothers with a newborn with congenital malformations in the intervention group receive interventions for reducing mental stress-related stress. The control group, which also includes the same mothers, does not receive the intervention.
Main outcome variables
Coping behaviors; attachment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190123042471N1
Registration date:2019-08-29, 1398/06/07
Registration timing:retrospective
Last update:2019-08-29, 1398/06/07
Update count:0
Registration date
2019-08-29, 1398/06/07
Registrant information
Name
Nahid Naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3552 7863
Email address
nahid.naseri93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-13, 1397/12/22
Expected recruitment end date
2019-06-29, 1398/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a Mindfulness-Based Stress Reduction (MBSR) Program on Coping Behaviors, and Attachment of Mothers of Neonates with Congenital Diseases in the selected hospitals affiliated to Shahid Beheshti University of Medical Sciences. 2019.
Public title
The effect of a Mindfulness-Based Stress Reduction (MBSR) Program on Coping Behaviors, and Attachment of Mothers of Neonates with Congenital Diseases in the selected hospitals affiliated to Shahid Beheshti University of Medical Sciences. 2018.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The mother has reading and writing skills.
The mother has ability to speak in Persian.
Having a Neonates under one week of congenital diseases that does not lead to a baby's death based on prediction and diagnosis.
The mother has no mental illness or anxiety disorders based on the documentation of the baby case.
The mother has no previous experience of having another child with congenital malformations, according to her mother's, and documentation of the case.
Mother has no education in psychology and medical sciences.
Be a biological mother.
The mother is not afflicted with sensory disorders such as deafness, blindness and .....
Mother has the desire and ability to attend a meeting.
Access to mobile phones and familiarity with Telegram software.
Exclusion criteria:
Mother's reluctance to participate in research.
Likely death of the baby according to clinical evidence and medical documentation.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Use Random Number Tables
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, Faculty of Pharmacy, Nursing and Midwifery, Shahid Beheshti University of Medical
Street address
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Intersection of niyayesh ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
19857174443
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.198
Health conditions studied
1
Description of health condition studied
Congenital disorders of the nervous system
ICD-10 code
Q05.0
ICD-10 code description
Cervical spina bifida with hydrocephalus
2
Description of health condition studied
Stress
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
3
Description of health condition studied
Congenital malformations of the digestive system
ICD-10 code
Q39.0
ICD-10 code description
Atresia of esophagus without fistula
4
Description of health condition studied
Cleft lip and palate cleft
ICD-10 code
Q35.5
ICD-10 code description
Cleft hard palate with cleft soft palate
5
Description of health condition studied
Congenital malformations of the liver, gall bladder and bile ducts
ICD-10 code
Q44.2
ICD-10 code description
Atresia of bile ducts
Primary outcomes
1
Description
Mother's coping behaviors
Timepoint
Measuring maternal coping behaviors before and after intervention (before the first session of mindfulness-based stress reduction program) and after intervention (four weeks after intervention, after four sessions of mindfulness-based stress reduction program face to face weekly).
Method of measurement
The McCobin Coping Health Inventory for Parents (CHIP) tool for measuring compatibility behaviors.
2
Description
maternal attachment to the infant
Timepoint
Measurement of maternal attachment to infant before and after intervention (before the first session of mindfulness-based stress reduction program) and after intervention (four weeks after intervention, after four sessions of mindfulness-based stress reduction program face to face weekly).
Method of measurement
The maternal attachment questionnaire for Candundas and Corkindal is used to measure attachment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The purpose of the intervention in this study is to conduct four sessions with maternal mindfulness-focused mental retardation content. The content of the sessions, respectively, includes the first session, referring, expressing feelings and thoughts, body scanning meditation, the second session including body scan exercises, three-minute breathing, the third session involves repeating the previous sessions and performing yoga movements. Finally, the fourth session will review the exercises and complete the questionnaires. Meetings will be held once a week and will last for 45-120 minutes.
Category
Behavior
2
Description
Control group: In the control group, mothers will not participate in mindfulness-related stress reduction sessions and will only complete the Health Alert Scale for parents and the attachment questionnaire for Candida and Corkindal's mother and infant.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh hospital
Full name of responsible person
Nahid Naseri
Street address
Shahid Rajabnia Street, Shisheh gar khaneh alley, Fadaiyan Islam St, Shosh Square
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
+98 21 5506 2627
Email
mahdieh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/
2
Recruitment center
Name of recruitment center
Mofid hospital
Full name of responsible person
Nahid Naseri
Street address
before Mirdamad, above of Hosseiniah Ershad, Shariati Street,
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
info-mch@sbmu.ac.ir
Web page address
https://mch.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Shahid Beheshti Nursing Midwifery Faculty, Intersection of Niayesh, Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
mhdolatian@gmail.com
Web page address
https://nm.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Naseri
Position
Master's student of neonatal intensive care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Nursing Midwifery Faculty, Intersection of Niayesh, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Naseri
Position
Master's student of Neonatal Intensive Care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery, Intersection of Niayesh, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Web page address
https://sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Naseri
Position
MSc NICU Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Nursing Midwifery Faculty,Intersection of Niayesh, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5363
Fax
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the questionnaire and only part of the main outcome information.
When the data will become available and for how long
Six months
To whom data/document is available
Nurses and nursing students
Under which criteria data/document could be used
Use in research related to knowledge of research subject.
From where data/document is obtainable
nahid.naseri93@gmail.com
Nahid Naseri
What processes are involved for a request to access data/document
Ten days after receipt of the email, the data will be available.