Determining the effect of spiritual care on the overall score of post-traumatic growth
Design
Clinical trial with control group, with parallel, randomized, phase 3 groups on 60 mothers. Lottery was used for randomization.
Settings and conduct
Neonatal Intensive Care Unit of UmolBanin , Imam Reza, Ghaem and Hashemi nejad Hospitals
Participants/Inclusion and exclusion criteria
A mother with a baby between 28 and 32 weeks of gestation
Intervention groups
After obtaining the consent of mothers of premature infants admitted to the neonatal intensive care unit of Imam Reza, Ghaem, Umm Al-Banin, Hasheminejad hospitals, spiritual care based on Richards & Bergin intervention method with Islamic approach during 8 sessions of 30 to 60 minutes for mothers of neonates The intervention will be performed. Mothers in the control group receive routine ward care. Post-traumatic growth is measured three times, once before the intervention, once immediately after the intervention, and once two weeks after the infant is discharged from the hospital.
Main outcome variables
posttraumatic growth
General information
Reason for update
Acronym
Neonatal intensive care unit
IRCT registration information
IRCT registration number:IRCT20210627051721N1
Registration date:2021-08-14, 1400/05/23
Registration timing:prospective
Last update:2021-08-14, 1400/05/23
Update count:0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Zahra Kariznoei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
kariznoeiz982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of spiritual care on posttraumatic growth mothers of preterm neonate, post discharge of NICU
Public title
Effect of spiritual care on posttraumatic growth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A mother with a neonate between 28 and 32 weeks of gestation
Mothers of neonates without congenital anomalies and chromosomal abnormalities
Mother of the baby without severe asphyxia
The mother should not use anti-anxiety and anti-depressant drugs before and during the study
No addiction of the mother
Lack of experience of a serious accident or serious family disputes in the last 6 months
The presence of the mother in the ward
Belief in Islam and Shiite religion
The mother does not already have a history of a premature baby alive
Exclusion criteria:
Maternal withdrawal from further study
Death or transfer of the baby to other centers
Clearance earlier than 12 days
Duration of hospitalization more than 4 weeks
Lack of cooperation of the mother to participate in more than two sessions
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be available and for allocating mothers of premature infants to intervention and control groups, first two hospitals will be selected by lot for sampling in the control group and two hospitals will be selected for sampling in the intervention group.
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 Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Ebne Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-07-06, 1400/04/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.036
Health conditions studied
1
Description of health condition studied
prematurity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Posttraumatic growth
Timepoint
Before the intervention, after the end of the intervention, two weeks after the discharge of the baby
Method of measurement
Tedeschi and Calhoun Post Traumatic Growth Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Spiritual care based on Richards & Bergin intervention method with Islamic approach will be done in 8 sessions of 30 to 60 minutes for mothers of newborns in the intervention group. In addition to spiritual care, the mothers of the intervention group benefit from the usual actions of the ward.
Category
N/A
2
Description
Control group: This group will receive NICU routine care, including daily visits by the mother and cuddling.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Zahra Kariznoee
Street address
Ebne Sina Street
City
MASHHAD
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
Kariznoeiz982@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Zahra Kariznoee
Street address
Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
Kariznoeiz982@mums.ac.ir
3
Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Zahra Kariznoee
Street address
Corner of Ayatollah Behjat 16, Zarrineh Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
91447347667
Phone
+98 51 3223 1061
Email
Kariznoeiz982@mums.ac.ir
4
Recruitment center
Name of recruitment center
Hasheminezhad Hospital
Full name of responsible person
Zahra Kariznoee
Street address
Moftteh Street, at the end of Abu Reihan Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3273 7011
Email
Kariznoeiz982@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Robab Latifnejad Roodsari
Street address
Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
latifnejadr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Kariznoei
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Kariznoeiz982@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghmeh Razaghi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
razaghin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghmeh Razaghi
Position
Faculty member of university
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
razaghin@mums.ac.ir
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