Determining the effectiveness of peer support through social networks on the stress and caregiving ability of mothers of premature after discharge
Design
The clinical trial study has a control group with a blinded and randomized parallel group on 60 mothers.
For randomization, lottery is done using closed pocket.
Settings and conduct
Place of operation and peer groups include 5 groups from 5 Qhaem and Imam Reza and Hasheminezhad and Umm OmolBanin and Shariati hospitals at Mashhad in NICU ward.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mother of premature babies with a gestational age of less than 30 weeks
The mother of a baby with a birth weight of less than 1500 grams
Willingness to participate in the study
Mother's physical health
Having a smartphone
The ability to use a smartphone and social networks;
Exclusion criteria:
Having any health-threatening congenital abnormalities
Mother's addiction
Intervention groups
Mothers who meet the criteria for entering the research will be included in the study after obtaining informed consent. The working method is that mothers are identified and enter the social network ETA up to 2 days before the discharge of the baby. Qualified peers also enter the group.
The research team will hold 2 sessions to teach care tips and prepare a peer support group for them. Peer groups will start communicating with the mother before discharge and will be in contact with the mothers of premature babies in the group during one month through the Ita social network. Peers provide psychological and emotional support to newly discharged mothers and provide them with their experiences according to the questions raised in the group. Peers are asked to give intellectual and advisory help to mothers in taking care of the baby in the first month.
Main outcome variables
Care capacity
Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230719058841N1
Registration date:2023-09-13, 1402/06/22
Registration timing:registered_while_recruiting
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
mahnaz ebrahimnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3382 4100
Email address
ebrahimnezhadm4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer support through social networks on the stress and caring ability of mothers’ premature infants after discharge
Public title
The effect of peer support through social networks on the stress and caring ability of mothers’ premature infants after discharge
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature babies with a gestational age of less than 30 weeks
Premature babies with a birth weight of less than 1500 grams
Willingness to participate in the study
Mother's physical health
Having a smartphone
The ability to use a smartphone and virtual space (social networks)
Exclusion criteria:
Having any health-threatening congenital abnormalities
Mother's addiction
Age
From 14 days old to 2 months old
Gender
Both
Phase
0
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is available and allocation of mothers of premature babies to two groups of control and intervention is random and by lottery with closed pocket.
The samples will be randomly divided into intervention and control groups. In order to randomly assign the participants to two groups, first 35 cards A (intervention group) and 35 cards B (control group) will be prepared. After shuffling the cards, the mothers are asked to take one card respectively, then the samples will be placed in one of the intervention or control groups based on the card taken. In this way, all participants will have an equal chance to be placed in two groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer don't know who is control or intervention group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central building of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.033
Health conditions studied
1
Description of health condition studied
Premature infant
ICD-10 code
060.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery
Primary outcomes
1
Description
The care ability of mothers of premature babies will be evaluated in the intervention and control groups
Timepoint
They will be evaluated before entering the group and one month after the intervention
Method of measurement
They are evaluated using the care capacity questionnaire
2
Description
The stress of mothers of premature infant
Timepoint
It is checked before entering the group and( after intervention) one month after the training
Method of measurement
They are evaluated using Cohen's questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Peer groups will start communicating with the mother before discharge and will be in contact with the mothers of premature babies in the group during one month through the Ita social network. Peers provide psychological and emotional support to newly discharged mothers and provide them with their experiences according to the questions raised in the group. Peers are asked to give intellectual and advisory help to mothers in taking care of the baby in the first month. Facilitating group discussion and providing correct scientific information and paying attention to the process of group dynamics and preventing the exchange of wrong information will be other duties of the researcher .Control group: mothers with premature babies receive routine care and can contact the department if they have any questions or problems. They complete the questionnaires before the baby's discharge and at the end of the first month after the discharge .The samples will be randomly divided into intervention and control groups. In order to randomly assign the participants to two groups, first 35 cards A (intervention group) and 35 cards B (control group) will be prepared. After shuffling the cards, the mothers are asked to take one card respectively, then the samples will be placed in one of the intervention or control groups based on the card taken. In this way, all participants will have an equal chance to be placed in two groups
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahnaz Ebrahimnezhad
Street address
Ebne sina Avenu
City
Mashhad
Province
Razavi Khorasan
Postal code
91379113316
Phone
+98 51 3854 3031
Email
razaghin@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mahnaz Ebrahimnezhad
Street address
Ahmedabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
ghaem@mums.ac.ir
3
Recruitment center
Name of recruitment center
Umm al-Binin Hospital
Full name of responsible person
Mahnaz Ebrahimnezhad
Street address
Behjat. BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۴۴٧٣۴٧۶٧
Phone
+98 51 3223 1061
Fax
+98 51 3223 1444
Email
oah@mums.ac.it
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayoor
Street address
Central Building of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahnaz Ebrahimnezhad
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Ebrahimnezhadm4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghme Razaghi
Position
Assistant professor of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebnecina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051338591511
Email
RazaghiN@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahnaz Ebrahimnezhad
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebnecina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Ebrahimnezhadm4001@mums.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
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
At the end of the work and after printing the article, with permission from the Mashhad Nursing and Midwifery Faculty and the relevant professors, the information will be accessible in the central library of the Mashhad Nursing and Midwifery Faculty in the student thesis.
When the data will become available and for how long
Access starts 3 months after results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Researchers with related fields can use the data and results by mentioning the reference.
From where data/document is obtainable
Correspondence with project manager, Dr. Naghme Razaghi RazaghiN@mums.ac.ir Postal code: 91778-99191
What processes are involved for a request to access data/document