Determining the impact of palliative care training on the performance of neonatal intensive care unit nurses
Design
Clinical trial, with control group, with parallel groups, without blinding, phase 3 on 70 nurses, Random Generator software will be used for randomization.
Settings and conduct
The location of the study will be the neonatal intensive care unit of Sadoughi and Afshar hospitals in Yazd; The studied population is all the nurses of the neonatal intensive care unit of Sadoughi and Afshar hospitals in Yazd
Participants/Inclusion and exclusion criteria
Inclusion criteria: working experience of at least 6 months in the special department for newborns with a degree in nursing and above; having consent to participate in the study. Exclusion criterion: previous history of participation in the palliative care training workshop
Intervention groups
The nurses of the intervention group will be taught palliative care in the form of a workshop for three days. And the nurses of the control group will not receive training and the scores of these two groups will be scored and compared using a checklist.
Main outcome variables
Performance score of nurses regarding the palliative care of newborns in the neonatal intensive care unit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231129060224N1
Registration date:2024-01-05, 1402/10/15
Registration timing:registered_while_recruiting
Last update:2024-01-05, 1402/10/15
Update count:0
Registration date
2024-01-05, 1402/10/15
Registrant information
Name
mina maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3333 2753
Email address
m.maleki@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of neonatal palliative care training on the performance of neonatal intensive care unit nurses
Public title
The impact of neonatal palliative care training on the performance of neonatal intensive care unit nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Work experience of at least 6 months in the special department for newborns with a nursing degree and above
Consent to participate in the study
Exclusion criteria:
Previous history of participating in palliative care training
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
All the nurses working in the neonatal intensive care unit of Shahid Sadoughi and Afshar hospitals will be allocated to groups using the Random Generator software, which is a random allocation software, and the qualified nurses will be equally placed in the intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar square
City
yazd
Province
Yazd
Postal code
8915887857
Approval date
2023-11-04, 1402/08/13
Ethics committee reference number
IR.SSU.REC.1402.061
Health conditions studied
1
Description of health condition studied
Palliative care
ICD-10 code
Z51.5
ICD-10 code description
Encounter for palliative care
Primary outcomes
1
Description
Performance of nurses in neonatal palliative care
Timepoint
Examining the performance of nurses regarding palliative care before the intervention and 14 and 21 days after the training workshop.
Method of measurement
Assessing nurses performance using the nurses performance checklist in palliative care
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a suitable schedule will be created for nurses to implement the nurse training program. which will include: date, place, subject, time and duration of each meeting. The educational program will include two parts, the theoretical part (definition of palliative care, benefits, principles, reasons, philosophy and the role of the nurse in relation to palliative care and...) and practical parts (the role of nursing related to pain control, comfort measures, symptom management, ventilation) It will cover treatment, oxygen therapy, nutrition and family support.And before the training, the performance of the nurses in the morning and evening shifts will be observed for 15-20 minutes and scored using the performance checklist by the assistant researcher. Then these sessions will be held in the study environment. The group will be trained in theoretical and practical sessions. And a copy of the training program will be given to each nurse, and after the training, the performance score of the nurses will be measured two weeks and four weeks later and will be compared with the control group.
Category
Other
2
Description
Control group: In the control group, no training will be given to nurses; And their performance score regarding the palliative care of newborns will be measured and graded using a checklist and will be compared with the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal intensive care unit; Yazd Shahid Sadoughi Hospital
Full name of responsible person
Khadijeh Dehghani
Street address
Ibn Sina St., Shahid Sadouqi Hospital, Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 2238 4000
Email
sadoghi-hospital@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Afshar Hospital, Yazd
Full name of responsible person
Khadijeh Dehghani
Street address
Mohammad Sadegh Afshar Hospital; Jomohri Blvd
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۹۴۵۵۵۶
Phone
+98 35 3525 5011
Email
afsharhospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi
Street address
Bahonar Boulevard ,the central building of Shahid Sadoughi University of Medical Sciences Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 2437 7111
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
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
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Dehghani
Position
Associate professor of Yazd University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bo Ali St., Shahid Sadoughi College of Nursing and Midwifery, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Dehghani
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bahnar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
khadijeh Dehghani
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bahnar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
098 35 2437 7101
Email
info@ssu.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
Yes - There is 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
Yes - There is 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
All data can potentially be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to data is possible by observing research ethics and referencing.
From where data/document is obtainable
Mrs. Khadijah Dehghani/ Yazd University of Medical Sciences/ dehghanish@ssu.ac.ir/ 09131535531
What processes are involved for a request to access data/document