Study objective: Postpartum depression is a serious and preventable disorder. Premature birth is a stressful event and 28 to 70 percent of the mothers had a high degree of stress. Among the treatments, religion has been considered as a complementary approach and the prayer is usually used in the harsh conditions.
Study design: A randomized , non- blind , controlled , non- placebo,
Study population: Mothers with preterm newborn less than 35 weeks gestational age, singleton and hospitalized in neonate intensive care unit(NICU).
Sample size: In both groups: 60, in each group: 30
Intervention: Tavasol praying with Mr. Farahmand’s voice played by audio devices
Intervention time: 20 minutes daily for 7 days
Study outcome: The effect of praying on depression, anxiety and stress of mothers with preterm newborn hospitalized in neonatal intensive care unit (NICU) immediately and one month after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100719429N1
Registration date:2015-01-07, 1393/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-07, 1393/10/17
Registrant information
Name
Maryam Sharifnia
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 4426
Email address
sharifniam891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Mashhad University of Medical Sciences. Building Qureshi, Daneshgah Avenue, Mashad. Zip code: 91375-345 Tell: 00985138411538 00985138412081-5 Fax:00985138430249 Email: vcresearch@mums.ac.ir
Expected recruitment start date
2013-08-08, 1392/05/17
Expected recruitment end date
2014-01-07, 1392/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of the effects of prayer on depression, anxiety and stress in mothers of preterm infants
Public title
Effect of praying on depression, anxiety and stress of mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria of mother:
• No more than two standard deviations from the mean difference of prayer questionnaire
• Infants with gestational age less than 35 weeks
• Obvious lack of psychiatric disorders such as psychosis , major depression , obsessive - compulsive , personality disorder characterized by a questionnaire SCL90
• A singleton baby
• No obvious physical deformities newborn
• Iranian nationality
Exclusion criteria:
• Infant death
• Infants discharged during 7 days
• Lack of cooperation and implementation of intervention by mother
Age
From 15 years old to 45 years old
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashad University of Medical Sciences
Street address
Building Qureshi, Daneshgah Avenue, Mashhad
City
Mashhad
Postal code
91375-345
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
920142
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
2
Description of health condition studied
Anxiety
ICD-10 code
F53.8
ICD-10 code description
Other mental and behavioural disorders associated with the puerperium, not elsewhere classified
3
Description of health condition studied
Stress
ICD-10 code
F53.8
ICD-10 code description
Other mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study, After intervention and 1 month later
Method of measurement
Depression‚ Anxiety‚ Stress Scale (DASS21)
2
Description
Depression
Timepoint
At the beginning of the study, After intervention and 1 month later
Method of measurement
Depression‚ Anxiety‚ Stress Scale (DASS21)
3
Description
Stress
Timepoint
At the beginning of the study, After intervention and 1 month later
Method of measurement
Depression‚ Anxiety‚ Stress Scale (DASS21)
Secondary outcomes
1
Description
Evaluate adherence to pray
Timepoint
At the beginning of the study
Method of measurement
Prayer Questionnaire Mravgylya
2
Description
Evaluation of mental health
Timepoint
At the beginning of the study
Method of measurement
Mental health Questionnaire(SCL90)
Intervention groups
1
Description
Tavasol praying with Mr. Farahmand’s voice played by audio devices 20 minutes daily for 7 days
Category
Prevention
2
Description
No intervention for control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Educational, Research and Treatment Center
Full name of responsible person
Fateme Chitgar Rahimi- Bachelor of Science in Nursing- Head nurse of Neonatal intensive care unite
Street address
Imam Reza Square,Avenue Ibn Sina
City
Mashhad
2
Recruitment center
Name of recruitment center
Bent al hoda hospital
Full name of responsible person
Maryam Jahani- Bachelor of Science in Nursing - Nurse Consulting Services
Street address
Bahar Street
City
Mashhad
3
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Zahra Parvini-Bachelor of Science in Nursing. Head Nurse of neonatal intensive care unite
Street address
Ahmedabad street, Doctor Shariarti square
City
Mashhad
4
Recruitment center
Name of recruitment center
Mosa Ben Jafar Hospital
Full name of responsible person
Mehrnaz Molai- Bachelor of Science in Nursing- Head Nurse of Neonatal intensive care unite
Street address
Emamreza Street - Emamreza 21
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mohsen Tafaghodi
Street address
Building Qureshi, Daneshgah Avenue, Mashad
City
Mashhad
Grant name
Grant code / Reference number
920142
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
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
Soheila Karbandi
Position
Master of nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
9137913199
Phone
+98 518591511
Fax
+98 51 3859 7313
Email
karbandis@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Karbandi
Position
Master of nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
9137913199
Phone
+98 518591511
Fax
+98 51 3859 7313
Email
karbandis@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Sharifnia
Position
Students of master of nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 518464426
Fax
Email
sharifniam891@mums.ac.irmrmsharifnia@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)