Investigating the Impact of Palliative Care on the Coping of Mothers with Hospitalized Neonates in the NICU

To evaluate the effect of palliative care on the adaptation of mothers with neonates admitted to the NICU.

This randomized clinical trial includes two groups (intervention and control), with 48 participants per group using simple random sampling. The study is single-blind (participants). Data will be collected at three time points and analyzed statistically.

This randomized clinical trial will be conducted in the NICUs of Shahid Sadoughi and Afshar hospitals in Yazd. Mothers will be randomly assigned to intervention (spiritual care) and control (routine care) groups. Data will be collected before and after the intervention. Randomization will be done using sealed envelopes, and only participants will be blinded.

Inclusion criteria: 1.Having a hospitalized neonate with complex medical conditions 2.Willingness and informed consent to participate in the study 3.Possession of Iranian nationality 4.Minimum literacy in reading and writing Exclusion criteria: 1.History of limiting physical illness in the mother (such as physical disabilities, mobility impairments, malignancies, or chronic/terminal diseases) 2.Documented history of psychiatric disorders in the mother 3.Previous experience of preterm birth or having a newborn admitted to the neonatal intensive care unit (NICU)

The intervention group consists of mothers receiving palliative care focused on spiritual care, including five 45-minute group sessions with meditation, relaxation, and coping skills training. The control group receives routine NICU care. Data are collected before and after the intervention in both groups.

Improved maternal psychological adaptation; reduced stress and anxiety due to neonatal hospitalization; enhanced maternal coping skills; strengthened mother-infant bonding.

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.

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.

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.

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.

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.

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.

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

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.