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Investigating the effect of a palliative care-based educational program on self-efficacy and resilience of mothers with premature neonate: A randomized controlled trial

Protocol summary

Study aim
This study examines the effect of palliative care-based education on the self-efficacy and resilience of mothers with premature infants
Design
A clinical trial with a control group, parallel groups, without blinding and without randomization, conducted on 70 mothers with premature infants.
Settings and conduct
By referring to Al-Zahra Educational and Medical Center (PBUH) in Rasht and from the neonatal and neonatal intensive care units, sampling will be conducted without randomization, considering the inclusion criteria. First, the control group will be selected and assessed, followed by the intervention group, where the educational program will be implemented.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with premature infants (gestational age 28-37 weeks), having at least basic literacy (ability to read and write), no history of giving birth to a premature infant in previous pregnancies, and no history of infant death in previous pregnancies. Exclusion criteria: Having psychological problems and taking psychiatric medications based on the mother's self-report, inability to communicate with others due to hearing, visual, or speech impairments, unwillingness of the mother to continue participation in the study, or infant death before completing the educational sessions.
Intervention groups
The intervention group will receive the palliative care-based educational program in four half-hour sessions, while the control group will receive the routine education provided by the respective ward
Main outcome variables
Measurable outcomes in this study include: the level of self-efficacy (before and one month after the intervention) and resilience (before and one month after the last educational session)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171008036651N5
Registration date: 2025-08-12, 1404/05/21
Registration timing: prospective

Last update: 2025-08-12, 1404/05/21
Update count: 0
Registration date
2025-08-12, 1404/05/21
Registrant information
Name
Yasaman Yaghobi
Name of organization / entity
Guilan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 6046
Email address
yasamanyaghobi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a palliative care-based educational program on self-efficacy and resilience of mothers with premature neonate: A randomized controlled trial
Public title
Investigating the effect of a palliative care-based educational program on self-efficacy and resilience of mothers with premature neonate
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who have hospitalized premature infants Mothers who are willing to participate in the study Mothers who have at least basic literacy skills Mothers who have no history of giving birth to a premature infant Mothers who have no history of infant death
Exclusion criteria:
Mothers with psychological and emotional problems Mothers who have difficulty communicating with others
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite 17 Shahrivar Hospital، Siadati Street، Namjoo Street
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2025-07-09, 1404/04/18
Ethics committee reference number
IR.GUMS.REC.1404.176

Health conditions studied

1

Description of health condition studied
Preterm newborn
ICD-10 code
P07.3
ICD-10 code description
Preterm newborn

Primary outcomes

1

Description
Self-efficacy
Timepoint
Before the start of the intervention and one month after the intervention
Method of measurement
Self-efficacy measurement questionnaire

2

Description
Resilience
Timepoint
Before the start of the intervention and one month after the intervention
Method of measurement
Resilience measurement questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 35 mothers with premature infants hospitalized will participate in four in-person training sessions over the course of one week
Category
Behavior

2

Description
Control group: 35 mothers with hospitalized premature infants who will receive routine training from the relevant department
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Fatemeh Hosseinzadeh
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9326
Fax
+98 13 3336 9024
Email
azzahra@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramyar Farzan
Street address
Parastar Street
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3334 6489
Email
riasat@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Yasaman Yaghobi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshjoo Street، Shahid Beheshti Highway
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3255 3202
Email
yasamanyaghobi@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Yasaman Yaghobi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshjoo Street، Shahid Beheshti Highway
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3255 3202
Fax
Email
yasamanyaghobi@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Yasaman Yaghobi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshjoo Street، Shahid Beheshti Highway
City
Rasht
Province
Guilan
Postal code
4146939814
Phone
+98 13 3255 3202
Fax
Email
yasamanyaghobi@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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