Determination of mindfulness self-compassion training effect on the fear of childbirth among primigravid women
Design
The clinical trial will be with an intervention group and a control group with a pretest and post-test design.
Settings and conduct
Sampling in the first stage is done by the convenience method and all primigravid women in Gorgan who are eligible to participate in the study will be selected. For this purpose, the researcher will extract the list of all primigravid women of Gorgan who eligible to enter the study will be called via telephone call after explaining of the research goal and obtaining oral informed consent. Intervention group will receive mindfulness self-compassion training during eight ninety-minute sessions Online or face-to-face group counseling and control group will not receive any training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being Iranian, ability to read and write in Persian, gestational age of 14-20 weeks, willing to participate in the study, having a smartphone and being able to work with it .
Exclusion criteria: mental disorders, history of suicide, history of taking psychiatric drugs, educated in medicine and para medicine and psychology, passing training courses including mindfulness, self-compassion and CBT
Intervention groups
womenin the intervention group will receive mindfulness self-compassion training during eight 90-minute sessions in the form of 12-person group sessions, online or face-to-face.
Main outcome variables
fear of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231025059856N1
Registration date:2023-11-19, 1402/08/28
Registration timing:prospective
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
sareh ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3255 7845
Email address
ebrahimi.s@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mindfulness self-compassion training on the fear of childbirth among first time pregnant women
Public title
Investigating the effect of mindfulness self-compassion training on the fear of childbirth among first time pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Ability to read and write in Persian
Gestational age 14-20 weeks
Willingness to participate in the study
Having a smart mobile and the ability to work with it
Exclusion criteria:
Psychopathy
Having a history of suicide
History of taking psychiatric drugs
Educated in the fields of medicine, paramedicine and psychology
Passing training courses including mindfulness, self-compassion and CBT
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible people will be randomly assigned to intervention and control groups. In order to randomize the study subjects, the randomization method using envelopes is used, so that first, sealed envelopes will be prepared for the number of eligible people, in half of them code A (intervention group) in half. Another code B (control group) is inserted, and therefore, for each selected sample, an envelope is randomly selected from among the envelopes, and after opening the envelope, the desired group is determined. In the next stage, another 22 qualified people will be selected and assigned to two control and intervention groups. Blinding is not considered in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Farhang Shahr real estate consultant, upper floor, between Sayad 14 and 16.Sayadshirazi Blvd.
City
Gorgan
Province
Golestan
Postal code
4917964441
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.GOUMS.REC.1402.317
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of childbirth
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the intervention
Method of measurement
Vijma version A fear of childbirth questionnaire and self-compassion questionnaire Long form (Neff et al., 2003)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mindfulness self-compassion training
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers in Gorgan ciry
Full name of responsible person
Narjes Sadat Borghei
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Deputy of Research and Technology, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
borghei2006@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Narges Begum Mir Behbahani
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Deputy of Research and Technology., Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Narjes Sadat Borghei
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Nursing and Midwifery School., Gorgan
City
Gorgan
Province
Golestan
Postal code
4913815739
Phone
+98 17 3245 6900
Email
borghei2006@ yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narjes Sadat Borghei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Nursing and Midwifery School., Gorgan
City
Gorgan
Province
Golestan
Postal code
4913815739
Phone
+98 17 3245 6900
Email
borghei2006@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sare ebrahimi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Nursing and Midwifery School., Gorgan
City
Gorgan
Province
Golestan
Postal code
4913815739
Phone
+98 17 3245 6900
Email
sarehebrahimi6459l@gmail.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For use in meta-analysis studies
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
Correspondence by e-mail with the responsible author stating the reason for the need to review the documentation
Sharing the topic by the responsible author with other authors
Data sharing if members agree