Investigating the impact of self-compassion-based intervention on self efficacy and fear of childbirth
Design
This study is a randomized clinical trial with a control group. This study is randomized, phase 2-3 study will be conducted on at least 56 eligible pregnant women. A table of random numbers is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in selected health centers in Kermanshah, is not blinded. The researcher and the participants have no role in randomly allocating intervention and control groups. First, mesenchymal stem cells are isolated from the placenta through enzymatic digestion. Before the start of the intervention, all participants complete the personal information form and questionnaires of fear of childbirth and self-efficacy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women of reproductive age (15-49 years); Being the first pregnancy; singleton pregnancy; Candidate for vaginal delivery; Gestational age 20-24 weeks; Moderate fear according to the score obtained from the fear of childbirth screening questionnaire; At least literate in reading and writing
Exclusion criteria: History of known mental illness; History of drug addiction and sedatives
Intervention groups
The intervention group will receive self-compassion-based training during eight sessions once a week for 60-90 minutes in groups (10-12 groups) in selected health centers. The control group will not receive any training and will only receive the usual prenatal care.
Main outcome variables
Self-efficacy, fear of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N218
Registration date:2024-06-14, 1403/03/25
Registration timing:prospective
Last update:2024-06-14, 1403/03/25
Update count:0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of self-compassion-based intervention on self efficacy and fear of childbirth in primiparous pregnant women
Public title
Investigating the impact of self-compassion-based intervention on self efficacy and fear of childbirth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age (15-49 years)
Being the first pregnancy
singleton pregnancy
Candidate for vaginal delivery
Gestational age 20-24 weeks
Moderate fear according to the score obtained from the fear of childbirth screening questionnaire
At least literate in reading and writing
Exclusion criteria:
History of known mental illness
History of drug addiction and sedatives
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:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Generate random numbers using online software. Divided quadrants will be drawn on 56 sheets of paper (in the number of patients) and random numbers will be written on each quadrant. Then, each of the papers will be placed in an envelope. Each patient removes an envelope and based on that, the method of placement of elastic seperator will be done in each quadrant. The production of random numbers and allocation concealment will be done by an impartial observer.
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-05-14, 1403/02/25
Ethics committee reference number
IR.KUMS.REC.1403.085
Health conditions studied
1
Description of health condition studied
Childbirth of fear
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Childbirth Self Efficacy
Timepoint
After the end of the intervention and 4 weeks after the intervention
Method of measurement
Base on childbirth self Efficacy inventory
2
Description
Fear of childbirth
Timepoint
After the end of the intervention and 4 weeks after the intervention
Method of measurement
Based on the fear of childbirth questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive self-compassion-based training during eight sessions once a week for 60-90 minutes in groups (10-12 groups) in selected health centers.
Category
Treatment - Other
2
Description
The control group will not receive any training and will only receive the usual prenatal care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Kermanshah city
Full name of responsible person
Dr. Sousan Heidarpour
Street address
Hafezieh St. - Health Center
City
Kermanshah
Province
Kermanshah
Postal code
4715813149
Phone
+98 83 3836 7909
Email
s.heydarpour1394@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sousan Heidarpour
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Isar Square, Faculty of Health
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
083338358943
Email
Mahsabarkhordari1375mb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sousan heidarpour
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Isar Square, Faculty of Health
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
Mahsabarkhordari1375mb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. sousan Heidarpour
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Isar Square, Faculty of Health
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
Mahsabarkhordari1375mb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD