Protocol summary

Study aim
The aim of this study was to investigate the effect of spiritual intelligence training on hope and self-esteem in mothers of neonates admitted to the neonatal intensive care unit of Fatemieh Hospital affiliated to Hamadan University of Medical Sciences.
Design
A randomized clinical trial with a control group, with two parallel groups
Settings and conduct
The present study will be conducted as a clinical trial with the participation of 80 mothers with premature infants admitted to Fatemieh hospital in Hamadan in 2020. Mothers will be randomly assigned to two groups: intervention and control. In the intervention group, the spiritual intelligence training protocol will be performed individually for 8 weeks in 8 weeks in the mothers of premature infants admitted to the hospital. No action will be taken in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have the ability to read and write,Have a premature baby between 28 and 32 weeks of gestation, Have no history of taking antidepressants, drugs or psychedelics Exclusion criteria: Failure to attend more than one training session, Unwilling to continue participating in the study
Intervention groups
In the intervention group, the spiritual intelligence training protocol will be performed individually in mothers of premature infants during 8 sessions in 8 weeks. No action will be taken in the control group.
Main outcome variables
hope and self-transcendence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160110025929N32
Registration date: 2020-08-16, 1399/05/26
Registration timing: prospective

Last update: 2020-08-16, 1399/05/26
Update count: 0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual intelligence training on hope and self-transcendence in mothers of premature newborns hospitalized in neonatal intensive care unit of Fatemie hospital affiliated to Hamadan University of Medical Sciences in 2020
Public title
effect of spiritual intelligence training on hope and self-transcendence in mothers of premature newborns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have the ability to read and write. Have a premature baby between 28 and 32 weeks of gestation. Have no history of taking antidepressants, drugs or psychedelics
Exclusion criteria:
Unwilling to continue participating in the study Failure to attend more than one training session
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation will be done using a random number table. Patients will be randomly divided into two groups intervention(A) and control (B).
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of medical Sciences,Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
38698-65178
Approval date
2020-07-04, 1399/04/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.120

Health conditions studied

1

Description of health condition studied
Premature infants
ICD-10 code
O42.00
ICD-10 code description
Premature rupture of membranes, onset of labor within 24 hours of rupture, unspecified weeks of gestation

Primary outcomes

1

Description
hope and self-transcendence
Timepoint
Before, immediately and 3 weeks after the intervention
Method of measurement
The scale of hope for mothers with premature infant and Self-transcendence scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The training sessions will be conducted by the researcher in 8 weeks and 8 sessions (90 minutes each session) individually and in the hospital location by the researcher. The contact number is obtained from the participants and in the virtual group formed by the researcher in WhatsApp software; In order to better understand the content by the mothers, at the beginning of each session, there will be a time to express the opinions and questions of the mothers, as well as questions and answers about the topics mentioned in the previous session.Hope Scale mothers of premature infants and self-transcendence scale before, immediately after, and 3 weeks of the study are evaluated.
Category
N/A

2

Description
Control group: In the control group with no intervention "Hope Scale mothers of premature infants" and "self-transcendence scale" while the intervention group before, immediately after, and 3 weeks of the study are evaluated.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Shohre Alimohammadi
Street address
Shahid Beheshti University of medical Sciences,Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
alimohammadi@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Beheshti University of medical Sciences,Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of medical Sciences,Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
38698-65178
Phone
+98 21 23871
Email
Farahani1381@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Dalvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of medical Sciences,Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
38698-65178
Phone
+98 21 23871
Email
Shadidalvand407@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Dalvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of medical Sciences,Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
38698-65178
Phone
+98 21 23871
Email
Shadidalvand407@gmail.com

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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