Evaluation of the effect of integrated care compared to usual care on maternal greif in bereaved mothers with perinatal loss
Design
A single-blind, parallel-group clinical trial with a control group, randomized by a randomization computer program with 128 participants, 64 in each group.
Settings and conduct
The setting of the study will be the maternity ward of Bahar Hospital in Shahroud city of Semnan province. The study population is hospitalized mothers with perinatal fetal loss.
Blinding will be done centrally by a statistician and the list of blocks will be made available to someone outside the research. This person will prepare envelopes containing the name of intervention or control in the order of the list and number them in order. Then the envelopes will be given to the person in charge of the delivery room. After obtaining informed consent from the bereaved mothers, the first thick sealed envelope will be given to the principal researcher by the delivery room manager from the numbered box.
Participants/Inclusion and exclusion criteria
Inclusion criterion: mothers with pregnancy loss. Exclusion criteria: Voluntary or legal abortion of pregnancy with clearly abnormal fetus, Having a mental illness or a history of it
Intervention groups
The intervention group: they will have a face-to-face consultation at the time of discharge from the hospital, and a virtual group counseling session will be conducted 20 to 35 days after discharge. From the time of discharge, they have been a member of the virtual information network for 2 months and will be able to receive training and advice.
Control group: At the time of discharge, they are not aware of their group and will receive only a pamphlet.
Main outcome variables
Maternal grief, psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230907059370N1
Registration date:2023-10-10, 1402/07/18
Registration timing:registered_while_recruiting
Last update:2023-10-10, 1402/07/18
Update count:0
Registration date
2023-10-10, 1402/07/18
Registrant information
Name
giti Atashsokhan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
gitiatashsokhan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-29, 1402/07/07
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of integrated care versus usual care on maternal grief in mothers with perinatal loss: a randomized clinical trial
Public title
Integrated care effect on grief of bereaved mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with perinatal loss
Stillbirth
Ectopic pregnancy
Fetal death immediately after birth during the mother's hospitalization
Abortion, miscarriage
Having smart phone
Being married
Exclusion criteria:
Suffering from mental illness
Having a history of psychological illness
Taking psychoactive drugs
Divorce
Experience a new crisis during past 6 months
Pregnancy loss with abnormal fetus
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of mothers is done using blocks of size four and by a Statistics specialist through computer-based randomization. Based on the table obtained from the allocation, envelopes that are numbered in sequence and contain the type of intervention or control are prepared by someone outside the research. The thick envelopes in the package are placed in a box in order. This box is given to the person in charge of the delivery room who is not involved in the research. After obtaining the consent of the participant to enter the study, an envelope will be opened by the delivery room manager.
The desired sample will be assigned to the specified group inside the envelope. Participants will not know about the allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (bereaved mothers) will receive the usual care, but the intervention group also will receive additional care. The intervention group will have face-to-face counseling and will have access to the virtual educational counseling network. The control group will only receive an educational pamphlet at the time of discharge from the hospital. Both groups are unaware of the allocation.
Clinical caregivers will perform all routine tasks for both groups and will not be informed.
The person responsible for data collection is a research assistant who will complete the questionnaires over the phone for both groups and will not be informed.
The statistician will analyze the data from the questionnaires and will not be informed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Taheri Ave
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.SHMU.REC.1400.011
Health conditions studied
1
Description of health condition studied
Maternal grief, psychological well-being
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maternal greif score in Perinatal Grief Scale ( potvin)
Timepoint
Before intervention, after virtual session, 2 months after discharge
Method of measurement
Perinatal Grief Scale
2
Description
Psychological well-being
Timepoint
Before intervention, 2 months after discharge
Method of measurement
Ryff scales of psychological well-being
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one face-to-face individual counseling session patient-centered for bereaved mother with an empathic approach before discharge from the hospital, two virtual peer group counseling sessions, and allocation of a virtual online counseling channel for bereaved mothers until the end of the sampling period.
Category
Rehabilitation
2
Description
Control group: receiving usual care and a general educational pamphlet at time of discharge
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity ward at Bahar hospital in Shahroud
Full name of responsible person
Giti Atashsokhan
Street address
Bahar Hospital, 22 Bahman street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 7607
Fax
Email
atashsokhan@shmu.ac.ir
Web page address
https://shmu.ac.ir/bahar/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hasan Imamian
Street address
7th Tir Square, Taheri St. Shahrood University of Medical Sciences.Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Phone
+98 23 3239 4852
Fax
Email
vcr@shmu.ac.ir
Web page address
https://shmu.ac.ir/research/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
2
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
Shahroud University of Medical Sciences
Full name of responsible person
Giti Atashsokhan
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
7th Tir square, Taheri street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
Atashsokhan@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Afsaneh Keramat
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
7th Tir square, Taheri street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
keramat1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Giti Atashsokhan
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
7th Tir square, Taheri street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
atashsokhan@shmu.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
After publishing the article and anonymizing the participants, the data file can be sent via email as requested
When the data will become available and for how long
After publishing the research paper of the project for 6 months
To whom data/document is available
for all Academic Researcher
Under which criteria data/document could be used
An approved proposal whose goals indicate the need for this information
From where data/document is obtainable
By Email
What processes are involved for a request to access data/document
After the approval of the project partners, the information will be sent within two weeks