Protocol summary

Summary
This Study is a Randomized Clinical Trial. The population consist of mothers that have premature infants hospitalize in neonatal intensive care unit in the Martyrs Kargar Hospital of Yazd. Mothers Who Have Post traumatic Stress Disorder select by PPQ Questionnaire (the perinatal PTSD Questionnaire) and Confirmation of physiological. Then they assign in three groups that each group have 30 members randomly. We Play Maryam s sura for the first group. also Play nonverbal Music include natural sounds such as the sound of the sea, rain, water, and mothers listen to these musics between 20-30 min daily for two weeks. Then They Fill out The PPQ(the Perinatal PTSD Questionnaire) questionnaire After The passing 2-4 weeks and compare it with the score of pretest. we give Quran and music cassette after the sampling for the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092911230N4
Registration date: 2016-10-30, 1395/08/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Zahra Pourmovahed
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
z_pourmovahed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Holy Quran Sound and non-verbal music therapy on post traumatic stress disorder in mothers of preterm infants hospitalized in the NICU
Public title
Effect of Holy Quran Sound and non-verbal music therapy on post traumatic stress disorder in mothers of preterm infants hospitalized in the NICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having a desire to participate in the study; being Muslim; complete consciousness; being literate; not having hearing problems; lack of drug addiction; not using of antidepressant and anti-anxiety drugs one month before of sampling; the not having of history post-traumatic stress disorder; not having history of premature infants in the NICU(neonatal intensive care unit); getting a score higher than 6 from PPQ Questionnaire (the perinatal PTSD Questionnaire). exclusion criteria:using of sedative and anti-anxiety drugs; occurring the stressful and unexpected events during the study; suffering the intermediate and severe depression and anxiety during the study; disinclination for continuing the participation in research study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Shahid Sadoughi University of Medical Sciences, Yazd
Street address
yazd,safaieh, boali street
City
yazd
Postal code
8916877391
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SSU.RSI.REC.1395.14

Health conditions studied

1

Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

Primary outcomes

1

Description
Post-traumatic stress disorder
Timepoint
before intervention- after intervention
Method of measurement
PPQ questionnaire(the Perinatal PTSD Questionnaire)

Secondary outcomes

empty

Intervention groups

1

Description
We Play Maryam s sura for the first group, and mothers listen to these musics between 20-30 minutes daily for two weeks. Then They Fill out The PPQ(the Perinatal PTSD Questionnaire) questionnaire After The passing 2-4 weeks.
Category
Behavior

2

Description
We Play nonverbal Music include natural sounds such as the sound of the sea, rain, water, and mothers listen to these musics between 20-30 min daily for two weeks. Then They Fill out The PPQ(the Perinatal PTSD Questionnaire) questionnaire After The passing 2-4 weeks and compare it with the score of pretest.
Category
Behavior

3

Description
control group: In control group no intervention is done
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyrs Kargar Hospital
Full name of responsible person
Zahra Pourmovahed
Street address
Faculty of Nursing and Midwifery, SafaiehStreet, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid SadoughiYazd University of Medical Sciences
Full name of responsible person
Zahra Pourmovahed
Street address
Faculty of Nursing and Midwifery, Safaieh Street, Yazd
City
Yazd
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 of Shahid SadoughiYazd 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
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Zahra Pourmovahed
Position
Master of Nursing, PhD Research Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Safaieh Street, Yazd
City
Yazd
Postal code
8916877443
Phone
+353 841752
Fax
Email
z_pourmovahed@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Zahra Pourmovahed
Position
Master of Nursing, PhD Research Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Safaieh Street, Yazd
City
Yazd
Postal code
8916877443
Phone
+353 841752
Fax
Email
Z_pourmovahed@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Zahra Pourmovahed
Position
Master of Nursing, PhD Research Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Safaieh Street, Yazd
City
Yazd
Postal code
8916877443
Phone
+98 35 3824 1753
Fax
Email
Z_pourmovahed@ssu.ac.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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