Objectives: To determine the effect of counseling with spiritual approach on stress and anxiety during pregnancy and delivery.
Design: Two-armed randomized controlled trial.
Conduct: This study will be conducted on pregnant women with gestational ages of 20 to 24 weeks referring to health centers of Maraghegh city. The researcher will refer to health centers and will provide a list of women with gestational ages of 20 to 24 weeks, then will call them and if they comply with the eligibility criteria and have tendency to participate in study, they will be invited to be present at the health center. In face to face session, the questionnaires of perceived stress and anxiety will be completed and the participants will be randomly assigned into two groups (one group receiving counseling and one control group) through block randomization with block sizes of four and six.
Participants: 112 women with gestational ages of 20 to 24 weeks.
Interventions: For the intervention group will be provided six 60-minute group sessions once a week. The control group will receive routine prenatal cares.
The main outcome variables are stress and anxiety during pregnancy and delivery that will be assessed four weeks after the end of intervention through questionnaires of perceived stress and Spielberger State-Trait Anxiety Inventory. The secondary outcomes are postpartum depression and anxiety that will be assessed through questionnaires of Edinburgh depression and Spielberger State-Trait Anxiety Inventory and also the neonatal anthropometric indices and delivery type that will be recorded according to childbirth file.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122710324N37
Registration date:2017-02-10, 1395/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
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
2017-01-27, 1395/11/08
Expected recruitment end date
2017-10-30, 1396/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with spirituality approach on stress and anxiety during pregnancy and delivery: a randomized controlled clinical trial
Public title
The effect of counseling with spirituality approach on stress and anxiety during pregnancy and delivery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with gestational age of 20 to 24 weeks; Pregnant women with first, second and third pregnancy; Having a contact number for follow-up; Participate in at least 2 sessions of all counseling sessions; Having Edinburgh depression score less than 12 before the intervention; Desire to delivery in Shahid Beheshti hospital of Maraghegh city.
Exclusion Criteria: Having a physical diseases (such as epilepsy, heart disease, etc.) according to woman’s expression; Having a mental illness according to woman’s expression; History of hospitalization due to current pregnancy complications (such as preterm labor, placental abruption, Hemorrhage, preeclampsia, etc); History of premature labor and other risk factors for preterm labor; Detection of fetal malformations; Occurrence of recent unpleasant events in the last three months; Using of cigarette, alcohol and opiates and other drugs that affect a person's body and mind; Prior participation in spiritual counseling classes
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
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 Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Postal code
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.TBZMED.REC.1395.1064
Health conditions studied
1
Description of health condition studied
Stress, anxiety and depression during pregnancy and puerperium
ICD-10 code
f53
ICD-10 code description
mental and behavioural disorders associated with the puerperium
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention, 4 weeks after the intervention, during labor and 6 weeks postpartum
Method of measurement
Spielberger State-Trait Anxiety Inventory
2
Description
Percieved stress
Timepoint
Before the intervention, 4 weeks after the intervention and during labor
Method of measurement
Perceived Stress Questionnaire
Secondary outcomes
1
Description
Postpartum depression
Timepoint
6 weeks postpartum
Method of measurement
Edinburgh Postnatal Depression Scale
2
Description
Neonatal anthropometric indices
Timepoint
After childbirth
Method of measurement
Childbirth file
3
Description
Delivery type
Timepoint
After childbirth
Method of measurement
Childbirth file
Intervention groups
1
Description
The control group will receive routine prenatal cares.
Category
N/A
2
Description
For the intervention group will be provided six 60-minute group sessions once a week.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in the city of Maragheh
Full name of responsible person
Masoomeh Haghighat
Street address
St. daneshsara, Maragheh city, East Azerbaijan
City
Maraghegh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, 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
Masoomeh Haghighat
Position
MSc Student of conseling in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 34772699
Fax
Email
m65haghighat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, 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
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery, 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
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)