Determining the effect of mindfulness-based counseling on pregnancy anxiety of pregnant women with a history of stillbirth
Design
The clinical trial has a randomized control group, an intervention and a control group of 50 people each, the type of randomization was block randomization with the size of 4.
Settings and conduct
The place of the study is the West and East health centers of Ahvaz city. The sample of the research is pregnant women referring to the health center who meet the conditions to entering the study. The participants are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the counseling based on mindfulness is used. The treatment program will be provided by the researcher in the form of an 8-session program(two sessions per week). Meetings will be held in groups. Contents and assignments will be presented to the intervention group on a weekly basis. The way to follow up the samples in 4 stages is to fill the questionnaire in the first session (pre-test), the last session (post-test) one month and two months after the last training session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with a gestational age of 14-24 weeks, a history of stillbirth in a previous pregnancy, having pregnancy anxiety (score 62 and above from the Vandenberg questionnaire)
Exclusion criteria: unwanted pregnancy, occurrence of any mental disorder requiring medication during the intervention, termination of pregnancy before the end of the intervention
Intervention groups
Participants are randomly assigned to two control and intervention groups. There is no intervention in the control group and counseling based on mindfulness is used in the intervention group.
Main outcome variables
Pregnancy anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230716058808N1
Registration date:2023-07-21, 1402/04/30
Registration timing:prospective
Last update:2023-07-21, 1402/04/30
Update count:0
Registration date
2023-07-21, 1402/04/30
Registrant information
Name
Maryam Bagherpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3390 9121
Email address
maryambaghrpoor1396@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based counseling on pregnancy anxiety in pregnant women with a history of stillbirth
Public title
The effect of mindfulness-based counseling on pregnancy anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with a gestational age of 14-24 weeks
History of stillbirth in previous pregnancy
Singleton pregnancy
Proficiency in Persian language
Having Iranian nationality
Having the ability to read and write
Having pregnancy anxiety (score 62 and above from the Vandenberg questionnaire)
Exclusion criteria:
Unwanted pregnancy
Occurrence of any mental disorder requiring medication during the intervention
Termination of pregnancy before the end of the intervention
Use of drugs or psychotropic substances
Having medical and midwifery problems based on the medical record
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, considering that we have two intervention and control groups, we will use a block of 4. In order to determine the allocation sequence using the 4 block method, random allocation sequence generation software will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of research and technology, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.AJUMS.REC.1402.222
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Pregnancy anxiety
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention, two months after the intervention
Method of measurement
Vanderberg Pregnancy Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Pregnant women with a history of stillbirth receiving mindfulness-based counseling. Mindfulness-based counseling uses mindfulness meditation practices and psychological strategies.In this method, mindfulness is based on 4 principles including Body awareness (body position and body movement/activity), body sensations (including those related to emotions), mental states (including emotional states) and mental content (thoughts, images) are taught. In this study, the participants who meet the study entry criteria are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the mindfulness-based counseling is used. Before starting the treatment program, the training certificate of the mindfulness course will be received and attached to the study, then the mindfulness-based counseling program for pregnancy anxiety in the form of an 8-session program during 4 weeks by The researcher will be presented. Meetings will be held in groups. Contents and assignments will be presented to the people of the intervention group on a weekly basis. It will be considered that the participants, whenever they have a problem in doing the assignments, have more interaction with the researcher in person or virtually to ensure the correctness of the assignments. How to follow up the samples in 4 steps by filling out the questionnaire The first session (pre-test), the last session (post-test), one month and two months after the last session after the last training session.
Category
Treatment - Other
2
Description
Control group: Pregnant women with a history of stillbirth without receiving mindfulness-based counseling
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
East Ahvaz Health Center
Full name of responsible person
Amralah Mardani
Street address
in front of Haft Tir Park - Shahid Rostagari street - Ayatollah Behbahani highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahand Jorfi
Street address
Deputy of research and technology, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
jorfi-s@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
It will be possible to access the research documents six months after the final statistical analysis.
To whom data/document is available
The data will be available only for the use of researchers of academic institutions
Under which criteria data/document could be used
In order to promote childbearing
From where data/document is obtainable
In order to receive the data, people can refer to the main executive of the project, Dr. Nahid Javadifar, a member of the academic staff of Jundishapur University of Medical Sciences, Ahvaz.
Email: nahidjavadifar_341@yahoo.com
What processes are involved for a request to access data/document
After obtaining the necessary permits from the Jundishapur University of Medical Sciences and the Vicechancellor of Research and Technology of this university, the applicant can proceed to receive the documents.