Protocol summary

Summary
Aim of this research is investigating training effects of spiritual self care on psychological interpenetration & life quality of mothers with preterm neonates admitted. In this study 60 mother with preterm neonate were selected randomly and were divided to two groups of intervention and control.Mothers in both groups completed short scale life quality questionnaire of WHO(WHOOL- BERF). Mothers in both group were informed a bout condition of their babies 15 minutes everyday for 14 days.In intervention group moreover than superior program spiritual self care training 45 minutes daily for 6 sessions was implemented.Followup performed by calling2 times a week for two weeks.Finally we wanted the mother ta attend the hospital.The baby was visited free by neonatalogist and mothers were asked to complete short scale life quality questionnaire.Including criterion:Satisfaction for participating in the study;preterm neonate with gestational age between 28 to 36 weeks;Iranian nationality;Muslim;At least five class literacy;Attending 14 days in ward;No depression;No addiction to drugs;No previous record of preterm baby.Excluding criterion:Congenital malformation;No propensity to continue the study;Neonatal discharge earlier than 14 days;Neonatal death;Twin birth

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201308018314N2
Registration date: 2013-09-11, 1392/06/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-11, 1392/06/20
Registrant information
Name
Mohammad Heidarzadeh
Name of organization / entity
Health Ministry
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 7313
Email address
heidarzadeh@health.gov.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research,Mashhad University of Medical science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating training effects of spiritual self care on psychological interpenetration & life quality of mothers with preterm neonates admitted in NICU
Public title
Investigating training effects of spiritual self care on psychological interpenetration & life quality of mothers with preterm neonates admitted in NICU
Purpose
Supportive
Inclusion/Exclusion criteria
Including criteria:Satisfaction for participating in the study؛preterm neonate with gestational age between 28 to 36 weeks;Iranian nationality؛Muslim؛At least five class literacy؛Attending 14 days in ward؛No depression؛No addiction to drugs؛No previous record of preterm baby.Excluding criteria:Congenital malformation؛No propensity to continue the study؛Neonatal discharge earlier than 14 days؛Neonatal death؛Twin birth .
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
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 Mashhad University of Medical Sciences
Street address
Mashhad University of medical sciences,Fakori street,Mashhad,Khorasan Razavi,Iran
City
Mashhad
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
911012

Health conditions studied

1

Description of health condition studied
Psychologic reaction to stress
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress

Primary outcomes

1

Description
Psychologic Interpenetration
Timepoint
Initial 5 days neonatal admition in NICU &14 days after i
Method of measurement
Score achieved by mother from tolerable agitated questionnaire

2

Description
Life Quality
Timepoint
Initial 5 days neonatal admitted in NICU &14 days after intervention
Method of measurement
Score achieved by mother from life quality questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group spiritual self care program training 45 minutes daily for 6 sessions was implemented.Followup performed by calling2 times a week for two weeks.Finally we wanted the mother to attend the hospital.The baby was visited free by neonatalogist and mothers were asked to complete short scale life quality questionnaire.
Category
Behavior

2

Description
Mothers in control group were informed a bout condition of their babies 15 minutes everyday for 14 days,Then completed short scale life quality questionnaire of WHO.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Mohammad Heidarzadeh
Street address
Ommolbanin hospital,Ayatolah Behjat sreet,Mashhad,Khorasan Razavi,Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research,Mashhad University of Medical science
Full name of responsible person
Mrs Reihani
Street address
Mashhad University of medical sciences,Fakori street,Mashhad,Khorasan Razavi,Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research,Mashhad University of Medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of medical sciences
Full name of responsible person
Sekhavatpor
Position
Master of science
Other areas of specialty/work
Street address
Mashhad University of medical sciences,Fakori street,Mashhad,Khorasan Razavi,Iran
City
Mashhad
Postal code
Phone
+98 64 1227 2337
Fax
Email
sekhavatz901@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health Ministry
Full name of responsible person
Dr. Mohammad Heidarzadeh
Position
Subspecialist of neonate
Other areas of specialty/work
Street address
Health Ministry,Hafez-Jomhory cross section,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 8859 1946
Fax
Email
heidarzadeh@health.gov.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health Ministiry
Full name of responsible person
Mohammad Heidarzadeh
Position
Subspecialist of neonate
Other areas of specialty/work
Street address
Health Ministry,Hafez-Jomhory cross section,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 8859 1946
Fax
Email
heidarzadeh@health.gov.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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