Neonatal Palliative CareNCT07902557
Effect of an Educational Program on Neonatal Intensive Care Nurses' Performance Regarding Neonatal Palliative Care in Egypt.
A study testing Neonatal Palliative Care Educational Program in people with Neonatal Palliative Care and Educational Intervention for NICU Nursing Performance, run by Asmaa Rashad at 1 site in Egypt.
Trial summary
This quasi-experimental study aims to evaluate the effect of an educational program on neonatal intensive care unit (NICU) nurses' performance regarding neonatal palliative care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neonatal Palliative Care, Educational Intervention for NICU Nursing Performance
- What is being tested?
- Neonatal Palliative Care Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Registered nurses currently working in the Neonatal Intensive Care Units (NICUs) at the study settings (e.g., Mansoura University Children's Hospital and Mansoura General Hospital).
- Clinical Experience: Minimum of 6 months to 1 year of continuous clinical practice in a NICU setting.
- Consent: Voluntary agreement and willingness to give informed written consent to participate in all study phases (pre-test, educational program, post-test, and 3-month follow-up).
- Availability: Present and actively working during the period of study implementation and intervention sessions.
Who cannot join
- Nurses who have previously attended specialized, formal training or certification programs in neonatal palliative care within the past 12 months.
- Part-time, temporary, or rotating student/trainee nurses with short-term clinical rotations in the NICU.
- Nurses who are planning to go on extended leave (e.g., maternity, study, or unpaid leave) during the active study timeframe (August 2025 - December 2025)
Trial locations and contacts
1 site in 1 country.
About this study
This quasi-experimental study aims to evaluate the effect of an educational program on neonatal intensive care unit (NICU) nurses' performance regarding neonatal palliative care. The study assesses nurses' knowledge and practice before and after the implementation of the educational intervention across selected hospitals in Egypt.
Read the detailed description
Palliative care in the Neonatal Intensive Care Unit (NICU) is essential for alleviating pain and addressing the physical, emotional, social, and spiritual needs of neonates facing life-threatening conditions and their families. Despite its importance, structured neonatal palliative care (NPC) training remains limited among nursing staff in many healthcare settings.
This study utilizes a quasi-experimental design (pre-test, post-test, and three-month follow-up) to evaluate the impact of a structured educational program on nurses' knowledge and clinical practice performance regarding neonatal palliative care.
The study is conducted in NICU departments across participating hospitals, . Participating nurses complete baseline assessments measuring their knowledge and clinical performance regarding NPC principles, pain management, end-of-life care, and family communication.
Following the pre-test assessment, participants undergo a comprehensive educational intervention consisting of theoretical sessions and practical training modules focused on neonatal palliative care standards. Post-intervention evaluations are conducted immediately following program completion and at a three-month follow-up to measure knowledge retention and long-term improvements in nursing practice.
- Being tested
- Neonatal Palliative Care Educational Program
- Keywords
- Palliative Care Intensive Care, Neonatal Neonatal Nursing / education Clinical Competence / standards Pain Management / nursing Terminal Care / methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal Palliative Care Educational ProgramBehavioural
A structured training program designed to enhance NICU nurses' knowledge and clinical performance regarding neonatal palliative care. The program includes theoretical interactive lectures and practical training sessions covering pain and symptom management, end-of-life care, ethical decision-making, bereavement support, and family-centered communication. Training materials (booklets and instructional guides) are provided, and participant progress is evaluated at baseline, immediately post-intervention, and at a 3-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Educational Program Group (or Neonatal Palliative Care Educational Intervention Group) | Experimental | NICU nurses in this arm receive a structured educational intervention on neonatal palliative care (NPC). The program consists of theoretical lectures, group discussions, and interactive practical modules covering pain management, symptom control, end-of-life care, and family-centered communication. Assessments (knowledge questionnaire and observational practice checklist) are conducted at baseline (pre-test), immediately following the intervention (post-test), and at a 3-month follow-up. Receives: Behavioral: Neonatal Palliative Care Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurses' Knowledge Regarding Neonatal Palliative Care (NPC)
Measured using the Neonatal Palliative Care Knowledge Questionnaire (adapted from Abuhammad et al., Ufashingabire et al., and Kassa et al.) comprising 15 multiple-choice items. The minimum possible raw score is 0 and the maximum possible raw score is 15 (converted to a percentage ranging from 0% to 100%, where scores ≥80% denote satisfactory knowledge and < 80% denote unsatisfactory knowledge based on Bloom's cut-off convention). A higher score indicates a better outcome (higher level of knowledge regarding neonatal palliative care).
Measured: Baseline (Pre-intervention) Immediately post-intervention 3-month follow-up
Nurses' Clinical Practice / Performance Regarding Neonatal Palliative Care
Measured using the Nurses' Practice Observational Checklist containing 37 procedures across eight domains (adapted from Mancini et al. and modified for the Egyptian clinical context). Each procedure is scored 0 (not performed) or 1 (performed), yielding a total score range from 0 to 37 (converted to a percentage where
≥80% denotes competent practice and <80% denotes incompetent practice). A higher score indicates a better outcome (higher clinical performance level and adherence to neonatal palliative care protocols)
Measured: Baseline (Pre-intervention) Immediately post-intervention 3-month follow-up
Nurses' Attitudes Toward Neonatal Palliative Care
Measured using the 20-item Nurses' Attitude Toward Neonatal Palliative Care Scale (adapted from the Frommelt Attitude Toward Care of the Dying Scale and modified by Sabaq and Khalaf). Responses are scored on a 3-point scale from 1 (disagree) to 3 (agree) with reverse-scoring for negative statements, yielding a total score range from 20 to 60 (converted to a percentage where
≥60% indicates a positive attitude and <60% indicates a negative attitude). A higher score indicates a better outcome (more favorable and positive attitude toward neonatal palliative care).
Measured: Baseline (Pre-intervention) Immediately post-intervention 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Aug 2025
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asmaa Rashad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asmaa Rashad, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902557
- Sponsor's protocol ID
- NUR (4/5/2025) (49)
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the ethical approval and informed consent agreements obtained from participating hospital review boards did not include explicit consent for secondary data sharing outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Program on Neonatal Intensive Care Nurses' Performance Regarding Neonatal Palliative Care in Egypt.
- ClinicalTrials.gov ID
- NCT07902557
- Acronym / sponsor ID
- NUR (4/5/2025) (49)
- Keywords
- Palliative Care Intensive Care, Neonatal Neonatal Nursing / education Clinical Competence / standards Pain Management / nursing Terminal Care / methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asmaa RashadUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This quasi-experimental study aims to evaluate the effect of an educational program on neonatal intensive care unit (NICU) nurses' performance regarding neonatal palliative care. The study assesses nurses' knowledge and practice before and after the implementation of the educational intervention across selected hospitals in Egypt.
Detailed description
Palliative care in the Neonatal Intensive Care Unit (NICU) is essential for alleviating pain and addressing the physical, emotional, social, and spiritual needs of neonates facing life-threatening conditions and their families. Despite its importance, structured neonatal palliative care (NPC) training remains limited among nursing staff in many healthcare settings.
This study utilizes a quasi-experimental design (pre-test, post-test, and three-month follow-up) to evaluate the impact of a structured educational program on nurses' knowledge and clinical practice performance regarding neonatal palliative care.
The study is conducted in NICU departments across participating hospitals, . Participating nurses complete baseline assessments measuring their knowledge and clinical performance regarding NPC principles, pain management, end-of-life care, and family communication.
Following the pre-test assessment, participants undergo a comprehensive educational intervention consisting of theoretical sessions and practical training modules focused on neonatal palliative care standards. Post-intervention evaluations are conducted immediately following program completion and at a three-month follow-up to measure knowledge retention and long-term improvements in nursing practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Program Group (or Neonatal Palliative Care Educational Intervention Group) | Experimental | Behavioral: Neonatal Palliative Care Educational ProgramNICU nurses in this arm receive a structured educational intervention on neonatal palliative care (NPC). The program consists of theoretical lectures, group discussions, and interactive practical modules covering pain management, symptom control, end-of-life care, and family-centered communication. Assessments (knowledge questionnaire and observational practice checklist) are conducted at baseline (pre-test), immediately following the intervention (post-test), and at a 3-month follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Registered nurses currently working in the Neonatal Intensive Care Units (NICUs) at the study settings (e.g., Mansoura University Children's Hospital and Mansoura General Hospital).
- Clinical Experience: Minimum of 6 months to 1 year of continuous clinical practice in a NICU setting.
- Consent: Voluntary agreement and willingness to give informed written consent to participate in all study phases (pre-test, educational program, post-test, and 3-month follow-up).
- Availability: Present and actively working during the period of study implementation and intervention sessions.
Key exclusion criteria (3 listed)
- Nurses who have previously attended specialized, formal training or certification programs in neonatal palliative care within the past 12 months.
- Part-time, temporary, or rotating student/trainee nurses with short-term clinical rotations in the NICU.
- Nurses who are planning to go on extended leave (e.g., maternity, study, or unpaid leave) during the active study timeframe (August 2025 - December 2025)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal Palliative Care Educational ProgramA structured training program designed to enhance NICU nurses' knowledge and clinical performance regarding neonatal palliative care. The program includes theoretical interactive lectures and practical training sessions covering pain and symptom management, end-of-life care, ethical decision-making, bereavement support, and family-centered communication. Training materials (booklets and instructional guides) are provided, and participant progress is evaluated at baseline, immediately post-intervention, and at a 3-month follow-up. | Behavioural | Educational Program Group (or Neonatal Palliative Care Educational Intervention Group) |
Primary outcome
Nurses' Knowledge Regarding Neonatal Palliative Care (NPC)
Time frame: Baseline (Pre-intervention) Immediately post-intervention 3-month follow-up
Measured using the Neonatal Palliative Care Knowledge Questionnaire (adapted from Abuhammad et al., Ufashingabire et al., and Kassa et al.) comprising 15 multiple-choice items. The minimum possible raw score is 0 and the maximum possible raw score is 15 (converted to a percentage ranging from 0% to 100%, where scores ≥80% denote satisfactory knowledge and < 80% denote unsatisfactory knowledge based on Bloom's cut-off convention). A higher score indicates a better outcome (higher level of knowledge regarding neonatal palliative care).
Nurses' Clinical Practice / Performance Regarding Neonatal Palliative Care
Time frame: Baseline (Pre-intervention) Immediately post-intervention 3-month follow-up
Measured using the Nurses' Practice Observational Checklist containing 37 procedures across eight domains (adapted from Mancini et al. and modified for the Egyptian clinical context). Each procedure is scored 0 (not performed) or 1 (performed), yielding a total score range from 0 to 37 (converted to a percentage where ≥80% denotes competent practice and <80% denotes incompetent practice). A higher score indicates a better outcome (higher clinical performance level and adherence to neonatal palliative care protocols)
Nurses' Attitudes Toward Neonatal Palliative Care
Time frame: Baseline (Pre-intervention) Immediately post-intervention 3-month follow-up
Measured using the 20-item Nurses' Attitude Toward Neonatal Palliative Care Scale (adapted from the Frommelt Attitude Toward Care of the Dying Scale and modified by Sabaq and Khalaf). Responses are scored on a 3-point scale from 1 (disagree) to 3 (agree) with reverse-scoring for negative statements, yielding a total score range from 20 to 60 (converted to a percentage where ≥60% indicates a positive attitude and <60% indicates a negative attitude). A higher score indicates a better outcome (more favorable and positive attitude toward neonatal palliative care).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the ethical approval and informed consent agreements obtained from participating hospital review boards did not include explicit consent for secondary data sharing outside the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal Palliative Care Educational Program in people with Neonatal Palliative Care and Educational Intervention for NICU Nursing Performance, run by Asmaa Rashad at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses' Knowledge Regarding Neonatal Palliative Care (NPC) (time frame: Baseline (Pre-intervention) Immediately post-intervention 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.