Objectives: This study aims to determine the effect of Quran voice with and without meaning on stress, anxiety and depression during pregnancy.
Design: Tree parallel arm Randomized Controlled Trial
Setting and conduct: This study will be conducted in Urmia health centers. Eligible women will be selected with convenience sampling and will be randomly assigned into 3 groups of 56 subjects with block sizes of 3 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: 168 pregnant women with gestational age 25-28 weeks
Interventions: First intervention group will receive Surah Maryam with the Persian meaning and the second group will receive Surah Maryam without meaning for 20 minutes weekly by researcher. The CD of Surah Maryam with and without meaning will be provided for both intervention groups, respectively in order to listen it at home. Also, the both intervention groups will receive routine prenatal care. The control group only will receive routine prenatal care.
Main outcome measures: Stress, anxiety and depression will be assessed by the Perceived Stress Scale (PSS), the Spielberger State-Trait Anxiety Inventory (STAI) and Edinburgh Postnatal Depression Scale (EPDS), respectively at baseline, 4 and 8 weeks after starting the intervention.
Secondary outcomes include the frequency of preterm delivery, cesarean delivery, and anthropometric indicators of newborn that will be assessed after delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021710324N16
Registration date:2014-06-04, 1393/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-04, 1393/03/14
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Quran voice with and without meaning on stress, anxiety and depression during pregnancy: a randomised controlled trial
Public title
The effect of Quran voice with and without meaning on stress, anxiety and depression during pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged 18 to 35 years; First and second pregnancy (no history of abortion and stillbirth); Singleton pregnancy and healthy fetus based on ultrasound; Gestational age of 25-28 weeks; Being literate; Willingness to participate in the study and regular attendance to receive the intervention and completion of questionnaires; Having a contact number for follow-up; Being Muslim and belief in Qur'an.
Exclusion criteria: Having history of psychiatric problems; Having history of drug abuse, smoking and addiction; Experiencing severe stressors such as the death of first-degree relatives, divorce and other problems in last three months; Having history of essential disease; Having complicated pregnancy such as hemorrhage, placenta previa, placental abruption and ...; Having depression score higher than of 12 based on Edinburgh scale; Having of sensorineural deafness.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
168
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan
City
Tabriz
Postal code
-
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
92231
Health conditions studied
1
Description of health condition studied
stress, depression, anxiety
ICD-10 code
F31, F32,
ICD-10 code description
Mood [affective] disorders
Primary outcomes
1
Description
Stress score
Timepoint
Before intervention, 4 and 8 weeks afterintervention
Method of measurement
Percieved Stress Scale
2
Description
Depression score
Timepoint
Before intervention, 4 and 8 weeks after intervention
Method of measurement
Edinburgh Postnatal Depression Scale (EPDS)
3
Description
State-Trait anxiety score
Timepoint
Before intervention, 4 and 8 weeks after intervention
Method of measurement
Spielberger Anxiety Inventory (STAI)
Secondary outcomes
1
Description
Preterm labour
Timepoint
After delivery
Method of measurement
Frequency
2
Description
Caesarean section
Timepoint
After delivery
Method of measurement
Frequency
3
Description
Anthropometric indicators of newborn
Timepoint
After delivery
Method of measurement
Centimeter
Intervention groups
1
Description
The first intervention group will receive Surah Maryam with the Persian meaning for 20 minutes weekly for sequential three weeks by researcher. The CD of Surah Maryam with meaning will be provided for this group in order to listen it at home.
Category
Other
2
Description
The second group will receive Surah Maryam without meaning for 20 minutes weekly for sequential three weeks by researcher. The CD of Surah Maryam without meaning will be provided for this group in order to listen it at home.
Category
Other
3
Description
The control group only will receive routine prenatal care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia health centers
Full name of responsible person
Batoul Jabbari
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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, Tabriz 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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Batoul Jabbari
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
15733-66156
Phone
+98 44 1223 1403
Fax
-
Email
beti_salas@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
51745-347
Phone
+98 41 1479 6770
Fax
-
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)