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The Effect Spiritual Care on Hope and Self-Transcendence of Mothers of Premature infants hospitalized in NICU

Protocol summary

Study aim
ِِِِDetermination The Effect Spiritual Care on Hope and Self-Transcendence of Mothers of Premature infants
Design
The study group is consisted of mothers with preterm infants in intensive care units. Mothers are non randomly selected. This study will be done on 30 mothers. A quasi-experimental clinical trial performed on mothers. The study has only one group.
Settings and conduct
The research environment of this study is Shohadaye-Bonab Hospital and Shahid Beheshti Hospital, Maragheh, Iran. One group is selected non-randomly, and the mothers will be trained to give spiritual care, as an intervention. The assessments would be done before, right after the test, and three weeks after the test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with premature neonates (28 to 34 weeks of gestational age); Being Iranian and Muslim; Residing in Tabriz city; being literate (having at least reading and writing skills). Non-inclusion criteria: Mothers with depression and other psychological disorders; History of using antidepressants or narcotics; A history of previous preterm infant hospitalization in the NICU; Having other illnesses other than prematurity
Intervention groups
Intervention and spiritual care training, four sessions, duration of each session, 45 minutes, the first session including referring, expressing goals and giving a pre-test questionnaire; the second session, identifying the spiritual needs; the third session, identifying the spiritual distress; the fourth session, in line with respect for The spiritual situation, the direction of the patient's beliefs and the encouragement and assistance of religious activities, including the expression of hopeful talk, morale and sympathy, the assessment of the effect of spiritual care and the closing of the sessions, and giving the mothers a post-test questionnaire .
Main outcome variables
Hope; Self-Transcendence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181117041679N1
Registration date: 2019-01-13, 1397/10/23
Registration timing: registered_while_recruiting

Last update: 2019-01-13, 1397/10/23
Update count: 0
Registration date
2019-01-13, 1397/10/23
Registrant information
Name
Mahnaz Afaghi Roveshty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3776 1238
Email address
mafagh1358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Spiritual Care on Hope and Self-Transcendence of Mothers of Premature infants hospitalized in NICU
Public title
The Effect of Spiritual Care on Hope and Self-Transcendence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with premature neonates (28 to 34 weeks of gestational age). Being Iranian and Muslim Residing in Tabriz city being literate (having at least reading and writing skills)
Exclusion criteria:
Mothers with depression and other psychological disorders History of using antidepressants or narcotics A history of previous preterm infant hospitalization in the NICU Having other illnesses other than prematurity
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Descriptive indexes are used to describe the data. For data analysis, statistical methods including descriptive statistics and t test and variance analysis of repeated measures are used.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Valieaser Street, Niayesh Station, Nursing And Medical Faculty, Shahid Beheshty Medical Univercity.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.153

Health conditions studied

1

Description of health condition studied
Spiritual Care
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of penjvini hope scale for mothers with preterm infants
Timepoint
The measurement of hope will be done at the beginning of the study (before the beginning of the study), and then after implementing the intervention during 6 sessions, and trainings will be done at the end of the intervention.
Method of measurement
Penjvini et al’s hope scale for mothers with preterm infants

2

Description
Self-Transcendence score in the Reed questionnaire
Timepoint
At the beginning of the study (before the beginning of the study), and then after implementing the intervention
Method of measurement
"The Effect Spiritual Care on Self-Transcendence of Mothers of Premature" How to evaluate Reed’s self-transcendence scale, which is translated and validated by Dr Farahani Shirin Abadi in 2016

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, only the effect of variable on one group of intervention group is considered. It is a quasi-experimental clinical trial. First, before the intervention, the test will be performed, then in the intervention group, spiritual care will be performed. Face-to-face and individual intervention involves four sessions, three sessions a week in the intensive care unit. The duration of each session is 45 minutes and the sessions are as follows: first session, referrals and acquaintance with mothers, expressing goals and giving a questionnaire to mothers, second session, conducting spiritual examination and identifying the spiritual needs of mothers, meeting 3, identifying spiritual distress Mothers, fourth session, in order to respect the moral status of mothers, to guide the patient's beliefs and encourage and assist in religious activities, express hopeful speeches, morale and comfort to mothers. Examining the impact of spiritual care and closing sessions And giving the mothers a questionnaire. Questionnaires will be completed at the first session before the intervention, the sixth session at the end of the intervention and 3 weeks after the last intervention session.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Shohada
Full name of responsible person
Mahnaz Afagh Roveshty
Street address
Bonab town
City
Bonab
Province
East Azarbaijan
Postal code
55518-87184
Phone
+98 41 3774 4530
Fax
+98 41 3773 0990
Email
mahnaz@domain.ac.ir
Web page address
https://fa.irct.ir/user/trial/35298/update/recruitment_center

2

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mahnaz Afagh Roveshty
Street address
Shahid Ayatollah Sadoughi Street, Street 15 Khordad
City
Maragheh
Province
East Azarbaijan
Postal code
5518-87184
Phone
+98 41 3722 8888
Fax
+98 41 3773 0990
Email
mafag1979@gmail.com
Web page address
https://fa.irct.ir/user/trial/35298/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hasan Esmaeili
Street address
Valieaser Street,Niayesh Station, Nursing And Medical Faculty, Shahid Beheshty Medical Univercity.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5368
Fax
+98 21 8865 5363
Email
mafagh1979@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahnaz Afagh Roveshty
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh intersection; Valieaser Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 41 3776 1238
Email
mafagh1358@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahna Afaghi Roveshty
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valieaser Street,Niayesh Station, Nursing And Medical Faculty, Shahid Beheshty Medical Univercity
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 41 3776 1238
Fax
Email
mafagh1979@gmail.com
Web page address
https://fa.irct.ir/user/trial/35298/update/recruitment_center

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahnaz Afaghi Roveshty
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh intersection; Valieaser Street
City
Tehran
Province
Tehran
Postal code
55518-87184
Phone
+98 41 3776 1238
Fax
+98 41 3773 0990
Email
mafagh1979@gmail.com
Web page address
https://fa.irct.ir/user/trial/35298/update/recruitment_center

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
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
No - There is not a plan to make this available
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