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IRCT20230907059370N1 IRCT 2023-10-10 Shahroud University of Medical Sciences Integrated care effect on grief of bereaved mothers Comparing the effectiveness of integrated care versus usual care on maternal grief in mothers with perinatal loss: a randomized clinical trial 2023-09-29 anticipated 128 Complete https://irct.ir/trial/72547 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Maternal grief, psychological well-being. Intervention 1: 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. Intervention 2: Control group: receiving usual care and a general educational pamphlet at time of discharge. Yes - There is a plan to make this available What will be shared: After publishing the article and anonymizing the participants, the data file can be sent via email as requested When: After publishing the research paper of the project for 6 months To whom: for all Academic Researcher Conditions: An approved proposal whose goals indicate the need for this information Where to obtain: By Email How to obtain: After the approval of the project partners, the information will be sent within two weeks Comments:
public Giti Atashsokhan
7th Tir square, Taheri street
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 5054 Atashsokhan@shmu.ac.ir Shahroud University of Medical Sciences scientific Afsaneh Keramat
7th Tir square, Taheri street
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 5054 keramat1@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Mothers with perinatal loss Stillbirth Ectopic pregnancy Fetal death immediately after birth during the mother's hospitalization Abortion, miscarriage Having smart phone Being married no limit no limit Female 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 Rehabilitation Rehabilitation 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. Control group: receiving usual care and a general educational pamphlet at time of discharge Maternal greif score in Perinatal Grief Scale ( potvin). Timepoint: Before intervention, after virtual session, 2 months after discharge. Method of measurement: Perinatal Grief Scale. Psychological well-being. Timepoint: Before intervention, 2 months after discharge. Method of measurement: Ryff scales of psychological well-being. Shahroud University of Medical Sciences Approved 2021-03-08 Ethics committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Taheri Ave Shahroud Semnan Iran (Islamic Republic of)