(1) Objective: determining the effect of hearing Quran on maternal and postpartum depression.
(2) Design: for this clinical trial 60 pregnant women referred to health centers of Gonabad city will be selected based on the inclusion criteria and by using systematic randomized method and at first, the Adinburgh depression inventory will be completed and those who score 12 and above will randomly assigned to two groups of control and intervention.
(3) Setting and conduct: the control group will receive just the routine care. In the intervention group, the CD of Quran voice will be delivered for listening at home in addition to receiving routine care. Then the questionnaire will be completed in both groups once after the end of the intervention (34-36 weeks of pregnancy) and again at 8 weeks after delivery.
(4) Participants including major eligibility criteria: inclusion criteria are reading and writing literacy; age between 18-35 years old; lack of extreme stressful event in the last three months; no history of smoking and drugs; primiparity; gestational age between 20-24 weeks; no disorder in the auditory system; lack of depression and known mental disease; health of the fetus based on ultrasonography and no specific problems; monogamy and no decision for divorce; being Muslim and Iranian citizenship. Exclusion criteria are request to withdraw from the study at any stage; hospitalization or death of the baby; preterm labor during the intervention; serious mental problems such as the death of first-degree family members during the intervention and with chronic Disease during the intervention.
(5) Intervention: in the intervention group, after the pre-test, the CD-ROM of the Qur'an voice will be delivered for listening at home. Participants in this group will listen to Surah al-Zamar on thursday night, and on thursday night, Surah Yasin will be listening on the seventh and eighth months of pregnancy.
(6) Main outcome measures: these variables are maternal and postpartum depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101317800N4
Registration date:2017-10-31, 1396/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-31, 1396/08/09
Registrant information
Name
Samane Najafi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 5027
Email address
najafi.s@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hearing Quran on maternal and postpartum depression
Public title
Maternal and postpartum depression
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: reading and writing literacy; age between 18-35 years old; lack of extreme stressful event in the last three months; no history of smoking and drugs; primiparity; gestational age between 20-24 weeks; no disorder in the auditory system; lack of depression and known mental disease; health of the fetus based on ultrasonography and no specific problems; monogamy and no decision for divorce; being Muslim; Iranian citizenship. Exclusion criteria: request to withdraw from the study at any stage; hospitalization or death of the baby; preterm labor during the intervention; serious mental problems such as the death of first-degree family members during the intervention; with chronic Disease during the intervention.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Approval date
2016-02-24, 1394/12/05
Ethics committee reference number
IR.GMU.REC.1394.77
Health conditions studied
1
Description of health condition studied
Bipolar affective disorder, current episode mild or moderate depression
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder, current episode mild or moderate depression
Primary outcomes
1
Description
Maternal and postpartum depression
Timepoint
Before and after the intervention
Method of measurement
The standard Adinburgh depression inventory
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, after the pre-test, the CD-ROM of the Qur'an voice will be delivered for listening at home. Participants in this group will listen to Surah al-Zamar on thursday night, and on thursday night, Surah Yasin will be listening on the seventh and eighth months of pregnancy.
Category
Other
2
Description
In control group, only routine prenatal cares will be provided and will not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Care Centers of Gonabad city
Full name of responsible person
Samane Najafi
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Samane Najafi
Position
MSc in nursing education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.