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IRCT20250416065351N1 IRCT 2025-06-01 Yazd University of Medical Sciences Investigating the Impact of Palliative Care on the Coping of Mothers with Hospitalized Neonates in the NICU Investigating the Impact of Palliative Care on the Coping of Mothers with Hospitalized Neonates in the NICU 2025-06-22 anticipated 88 Complete https://irct.ir/trial/83539 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants will be randomly assigned into two groups using a simple randomization method based on a list generated by PASS 2023 software. To ensure allocation concealment, participant numbers will be placed inside sealed envelopes. As eligible participants are enrolled, they will receive envelopes in order, which will then be provided to the researcher for intervention assignment, Blinding description: This study is conducted as a single-blind trial in which the participants (mothers) are unaware of the type of intervention they receive (intervention or control group). Random allocation is performed using a list generated by PASS 2023 software and a simple randomization method. To ensure allocation concealment, group assignment codes are placed in opaque, sealed envelopes. Upon enrollment, each participant receives one envelope in sequential order and is assigned to a group accordingly. The researcher is aware of the group allocation, but the participants remain blinded throughout the study. 3 Psychological Adaptation of Mothers with Infants Admitted to the Neonatal Intensive Care Unit (NICU). Intervention 1: Intervention group: Mothers in this group will receive a structured palliative care program with a spiritual care focus. The intervention includes five 45-minute group sessions providing meditation, progressive muscle relaxation, spiritual support, coping skills training, and enhancement of mother-infant bonding. The sessions are delivered by the researcher in the hospital setting. Intervention 2: Control group: Mothers in this group will receive only the routine neonatal intensive care unit services provided by the hospital, with no additional intervention from the researcher. Yes - There is a plan to make this available What will be shared: Individual participant data will be shared in SPSS format after removing all identifiable personal information. The dataset will include all variables used in the study, enabling researchers to reanalyze and utilize the data. Data sharing will occur after the study has been fully completed. When: Access to the de-identified dataset will be available starting six months after the publication of the final study results and will remain accessible for three years thereafter. To whom: The data and study documents will only be available to researchers and academic staff affiliated with medical universities and research centers. Requests from other individuals or organizations will be subject to review and approval by the ethics committee and research team. Conditions: In addition to the aforementioned conditions, applicants must submit a written statement of their research objectives and commit to using the data solely for research purposes. Any commercial use, publication, or sharing without written permission is prohibited. Applicants are also required to maintain data confidentiality and adhere to research ethics. Data usage is limited to analyses related to the study topic, and any use beyond this requires further approval from the research team. Where to obtain: Primary Contact: Ms. Khadijeh Dehghani Faculty member, School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd Email: shadehghani@gmail.com Mobile: +98 913 153 5531 Secondary Contact: Ms. Shima Daftari Raeini Faculty member, School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd Email: shimadaftari@gmail.com Mobile: +98 938 612 1416 Postal Address: Yazd, Timsar Fallahi Street, Bu-Ali Street, School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd How to obtain: After submitting a written request to one of the designated contacts, the request will be reviewed and approved. Upon approval, the process of preparing and delivering the data or documents will begin. Typically, this process takes between 2 to 4 weeks, depending on the volume of the request and the preparation needed. If additional information or final confirmation is required, the contact person will communicate with the applicant. Comments:
public Khadijeh Dehghani
School of Nursing and Midwifery, Bouali Street, Timsar Fallahi Street, Yazd, Iran
Yazd Iran (Islamic Republic of) 8916877443 +98 35 3724 0171 shadehghani@gmail.com Yazd University of Medical Sciences scientific Khadijeh Dehghani
School of Nursing and Midwifery, Bouali Street, Timsar Fallahi Street, Yazd, Iran
Yazd Iran (Islamic Republic of) 8916877443 +98 35 3724 0171 shadehghani@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having a hospitalized neonate with complex medical conditions. Willingness and informed consent to participate in the study. Possession of Iranian nationality. Minimum literacy in reading and writing. no limit no limit Both History of limiting physical illness in the mother (such as physical disabilities, mobility impairments, malignancies, or chronic/terminal diseases). Documented history of psychiatric disorders in the mother. Previous experience of preterm birth or having a newborn admitted to the neonatal intensive care unit (NICU). Behavior Behavior Intervention group: Mothers in this group will receive a structured palliative care program with a spiritual care focus. The intervention includes five 45-minute group sessions providing meditation, progressive muscle relaxation, spiritual support, coping skills training, and enhancement of mother-infant bonding. The sessions are delivered by the researcher in the hospital setting. Control group: Mothers in this group will receive only the routine neonatal intensive care unit services provided by the hospital, with no additional intervention from the researcher. Psychological adjustment of mothers with neonates admitted to NICU, assessed using the Carver’s Coping Skills Questionnaire. Timepoint: The primary outcome is measured at three time points: before the intervention, immediately after the completion of the intervention sessions, and three weeks post-intervention. Method of measurement: Psychological adaptation is measured using the 40-item Carver Coping Strategies Questionnaire. Yazd University of Medical Sciences Approved 2025-05-13 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Central Administration, Shahid Dr. Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)