Investigation of the effect of video interaction guidance on the intensity of grief in mothers with premature infant
Design
The research is a quantitative interventional study of semi-experimental method, two groups of control and intervention on mothers with premature babies hospitalized under 37 weeks of pregnancy in the neonatal intensive care unit
Settings and conduct
Sampling will be done as available and every day in a rotating shift at Yas Hospital located in Tehran according to the entry criteria of mothers, a total of 72 people, 36 people will be in the control group and 36 people will be in the intervention group, and the sampling will be done simultaneously.
Participants/Inclusion and exclusion criteria
1) Over the age of 18
2) Literate to read and write
3) Having a premature baby girl or boy born under 37 weeks of pregnancy and admitted to the neonatal intensive care unit
4) Absence of known physical and psychological diseases
5) Absence of alcohol and drug addiction
6) Not having a history of divorce and separation from spouse during pregnancy
7) Having relative familiarity with mass communication tools
8) Absence of anomalies at the time of birth in the baby
9) Mothers will not be included in the study if they do not want to cooperate
Intervention groups
In the intervention group, Intervention of the Video Interaction Guidance (VIG) will be implemented for one week, which includes filming 5 for up to 10 minutes three times and editing and re-showing moments of positive interaction between mother and baby three times. Mothers in the control group will receive just routine care and no more additional intervention.
Main outcome variables
The severity of mothers' grief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039464N6
Registration date:2023-02-15, 1401/11/26
Registration timing:prospective
Last update:2023-02-15, 1401/11/26
Update count:0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Marzieh Hasanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4413
Email address
m-hasanpour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of applying video interaction guidance on the intensity of grief in mothers with premature infant
Public title
Investigation of the effect of applying video interaction guidance on the intensity of grief in mothers with premature infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Over the age of 18
Literate to read and write
Having a premature baby girl or boy born under 37 weeks of pregnancy and admitted to the neonatal intensive care unit
Absence of known physical and psychological diseases (cancer, chronic and acute diseases, depression, etc.) in the initial evaluation as self-reported by mothers
Absence of alcohol and drug addiction in the initial assessment and as self-reported by mothers
Not having a history of divorce and separation from spouse during pregnancy
Having relative familiarity with mass communication tools such as mobile phones and working with mass communication software and social networks to connect the researcher with mothers
Absence of anomalies at the time of birth in the baby due to the prolonged grief process in mothers
Exclusion criteria:
The mother's unwillingness to continue participating in the study at any stage of the research
Sudden deterioration and infant death at every stage of research and intervention implementation
Early discharge (less than one week of intervention) of the baby from the neonatal intensive care unit
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Mothers with premature baby hospitalized in the neonatal intensive care unit will be selected by Convenience sampling method and will be assigned to the intervention and control groups by 4 block randomization method. Allocation of groups is based on randomization with 18 groups of 4 people (72 people in total) who will be randomly assigned to group A (control group) and group B (intervention group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling of the intervention and control groups will be done at the same time, mothers will be randomly assigned to the intervention and control groups. After giving informed consent and completing the pre-test pre-maturity grief questionnaire, the mothers of the intervention group will have three sessions video interaction guide and feedback intervention during the first week of the newborn's hospitalization in the neonatal intensive care unit. After the end of the first week, the post-test questionnaire will be administered. After the first test and after the end of the second week, the second post-test questionnaire will be provided to the mothers. In the control group, after informed consent and collecting the pre-test questionnaire from the mothers, one week and two weeks after the admission of the newborn in the neonatal intensive care unit, the first post-test and the second post-test will be provided to mothers and will be collected after completion. There will be no intervention on the mothers of the control group, but it should be noted that the mothers of the control group will receive the usual care during the intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Room 604, 6th floor, central building of Tehran University of Medical Sciences, intersection of Qods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-12-11, 1401/09/20
Ethics committee reference number
IR.TUMS.FNM.REC.1401.118
Health conditions studied
1
Description of health condition studied
Intensity of Grief in Mothers with Premature Infant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of Grief in Mothers with Premature Infant
Timepoint
The first assessment of the severity of grief of mothers with premature babies before the start of the intervention will be by Hasanpour, Zarezadeh's Pre-maturity Grief Questionnaire. The second measurement will be one week after the start of the intervention and the third measurement will be two weeks after the start of the intervention.
Intervention group: Before the start of the intervention, the informed consent form and the pre-maturity grief pre-test questionnaire will be completed after the first interaction with the baby in the neonatal intensive care unit, on the first day of the intervention, the first filming of mother-baby interactions will be done, on the second day of the intervention, the videos will be edited by the researcher and selected Better moments than usual will be done, on the third day of the intervention, the first video interaction guidance session (watching the golden moments of mother-baby interaction by the researcher and the mother, positive feedback to the mother by the researcher) + the second filming, on the fourth day of the editing intervention Videos by the researcher, on the fifth day of the intervention, the second session of the video interaction guidance + the third filming, on the sixth day of the intervention, editing of the videos by the researcher, on the seventh day of the intervention, the third session of the video interaction guidance + completion of the first post-test questionnaire, at the end of the second week The questionnaire will be completed.
Category
Behavior
2
Description
Control group: Before starting the intervention, the informed consent form and the completion of the pre-test questionnaire of pre-maturity grief will be done by the mother after the first interaction with the baby in the neonatal intensive care unit, at the end of the first week, the completion of the post-test questionnaire and at the end of the second week The second will be done.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital Complex
Full name of responsible person
Dr. Arash Jafarieh
Street address
North Nejat Elahi St., Mirzai Shirazi St., next to Sarvo St., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0468
Fax
+98 21 8894 8217
Email
yashospital@gmail.com
Web page address
https://yashospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Ghenaati
Street address
Tehran University of Medical Sciences, Keshavarz Blvd, Qods, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 1080
Email
chancellor@tums.ac.ir
Web page address
https://chancellor.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
40
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
Marzieh Hasanpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
m-hasanpour@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Hasanpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
m-hasanpour@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Hasanpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
m-hasanpour@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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