To investigate the effect of spiritual counseling on pregnancy acceptance and anxiety reduction
Design
This study is a randomized clinical trial with control and parallel groups on 110 first trimester pregnant women in Shiraz. Allocation to intervention and control groups is done without randomization. The intervention group receives spiritual counseling and the control group receives usual care.
Settings and conduct
This study will be conducted in health centers in Shiraz. After identifying eligible first-trimester pregnant women and obtaining informed consent, participants will complete initial questionnaires. Then, individuals will be non-randomly assigned to two intervention and control groups. The intervention group will receive spiritual counseling based on a researcher-developed protocol in addition to usual care, while the control group will receive only usual care. After the intervention, the questionnaires will be completed again by the participants.
Participants/Inclusion and exclusion criteria
110 first-trimester pregnant women in Shiraz will be randomly assigned to intervention and control groups.
Inclusion criteria: first-trimester pregnancy, uncertainty about pregnancy continuation or acceptance, pregnancy-related anxiety, and informed consent.
Exclusion criteria: Unwillingness to participate in the study, Mother's blindness and deafness, Mental and physical retardation of the mother
Intervention groups
participants in the intervention group will receive spiritual counseling based on a researcher-developed protocol and will complete the study questionnaires before and after the intervention.
Comparison group: Mothers who only received routine prenatal care and did not receive spiritual counseling
Main outcome variables
Pregnancy acceptance Pregnancy-related anxiety
These outcomes will be measured using validated questionnaires before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260629070002N1
Registration date:2026-08-17, 1405/05/26
Registration timing:prospective
Last update:2026-08-17, 1405/05/26
Update count:0
Registration date
2026-08-17, 1405/05/26
Registrant information
Name
Nasim Bozorgi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 167 9463
Email address
nasimbozorgi94@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-11, 1405/06/20
Expected recruitment end date
2026-12-11, 1405/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spiritual Counseling on Pregnancy Acceptance and Reduction of Anxiety
Public title
The Effect of Spiritual Counseling on Pregnancy Acceptance and Reduction of Anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The mother has doubts about deciding to continue the pregnancy.
No underlying disease in the mother or fetus that threatens the mother's life and requires a legal abortion
Must be a resident of Fars province
Exclusion criteria:
Mental and physical retardation of the mother
Mother's blindness and deafness
Unwillingness to participate in the study
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Ethics Committee of qom medical science university
Street address
Azadegan
City
Shiraz
Province
Fars
Postal code
7154866697
Approval date
2026-06-14, 1405/03/24
Ethics committee reference number
IR.MUQ.REC.1405.089
Health conditions studied
1
Description of health condition studied
Pregnancy Acceptance and Reduction of Pregnancy Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study and before receiving spiritual counseling, pregnancy anxiety is measured using a questionnaire. Then, two weeks after spiritual counseling, the effect of spiritual counseling on pregnancy anxiety is measured.
Method of measurement
Measuring pregnancy anxiety using the Vandenberg Pregnancy Anxiety Questionnaire
2
Description
Miscarriage
Timepoint
Before spiritual counseling, adjustment to pregnancy is measured using the Prenatal Self-Evaluation Questionnaire (PSEQ). Then, the effect of spiritual counseling on pregnancy acceptance is measured two weeks after counseling.
Method of measurement
Adaptation to pregnancy by the Prenatal Self-Assessment Questionnaire (PSEQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant women in the first trimester who refer to Shiraz health and medical centers who have doubts or have not fully accepted the continuation of pregnancy, after entering the study and becoming aware of it, complete a demographic questionnaire, a Prenatal Self-Evaluation Questionnaire (PSEQ), a Vandenberg Pregnancy Anxiety Questionnaire (PRAQ), and a comprehensive Jaberi Spiritual Health Assessment Questionnaire, and undergo an initial assessment. They then undergo spiritual counseling according to a researcher-made protocol, meaning they receive three counseling sessions, each session lasting 30 to 45 minutes. The content of the protocol, which includes verses, hadiths, stories, and counseling, as well as using their spouse and family to support them, is completed by them again two weeks later. In the intervention, during three sessions, the content of the spiritual counseling protocol, which consists of Quranic verses and hadiths, as well as the fate of mothers mentioned in the verses and hadiths, is told to them, family support or existing support groups are provided to them, and if they are unable to visit in person, counseling will be provided over the phone. There is no other intervention group, only this intervention, which includes spiritual counseling, and the control group that was described.
Category
Lifestyle
2
Description
Control group: Mothers who only receive routine pregnancy care, meaning they do not undergo spiritual counseling sessions when visiting the clinic and after completing the questionnaire, and are only given recommendations to reduce maternal anxiety by the midwife who provides their care, as usual, and then complete the questionnaire again two weeks later.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthcare and Medical Centers in Shiraz
Full name of responsible person
Nahid Mehran
Street address
Enghelab
City
Shiraz
Province
Fars
Postal code
71737 75617
Phone
+98 71 3232 4805
Email
Nasimbozorgi94@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Nahid Mehran
Street address
Shahid Javad Del Azar Boulevard
City
Qom
Province
Ghoum
Postal code
7654876543
Phone
+98 25 3107 1111
Email
Nasimbozorgi94@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Nasim Bozorgi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Azadegan
City
Shiraz
Province
Fars
Postal code
7154866697
Phone
+98 930 167 9463
Email
Nasimbozorgi94@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Nahid Mehran
Position
Associate proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid delazar
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3456 7893
Email
Nasimbozorgi94@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Nasim Bozorgi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Azadegan
City
Shiraz
Province
Fars
Postal code
7154866697
Phone
+98 930 167 9463
Email
Nasimbozorgi94@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main outcome will be shared.
When the data will become available and for how long
4 months after results are published
To whom data/document is available
For use in research or scientific, academic, and clinical uses
Under which criteria data/document could be used
The data and documents obtained from this study will be used solely for scientific and research purposes, including data analysis and re-analysis, conducting related research, and preparing scientific articles and reports. Following completion of the study, access to the data will be possible only upon submission of a justified scientific request and approval by the principal investigator. If the data are shared with other researchers, they will be provided in an anonymized form without any identifying information, and the confidentiality of participants’ information will be fully maintained. The use of the data for commercial purposes or for identifying participants will not be permitted.
From where data/document is obtainable
After printing the results, please refer to the corresponding author's email.
N_mehran59@yahoo.com
Dr. Nahid Mehran
PhD in Reproductive Health
Assistant Professor, Qom University of Medical Sciences
What processes are involved for a request to access data/document
After printing the results, please refer to the corresponding author's email. After reviewing the request and necessary correspondence with them, the corresponding author will send the data within two weeks, if deemed appropriate.