The effect of Acceptance and Commitment therapy (ACT) with and without the presence of the spouse on the fear of childbirth and the choice of the type of childbirth in primigravida women
Determining the effect of commitment and acceptance therapy (ACT) with and without the presence of the spouse on the fear of childbirth and the choice of the type of childbirth in primigravida women
Design
A clinical trial with a randomized control group and a random permutation block method, without blinding, with parallel groups, on 108 pregnant mothers.
Settings and conduct
This study will be conducted in selected comprehensive health centers of Ahvaz city. The participants will be randomly placed in three control groups, the test with the presence of the spouse and the test without the presence of the spouse. In addition to receiving usual pregnancy care, the two test groups will receive counseling based on commitment and acceptance as a group. Counseling will be held in 8 sessions of 90 minutes each week. Two intervention groups of 36 people are divided into 6 groups of 6 people each.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primigravida women with a gestational age of 28 to 32 weeks؛ maternal age of 18 to 35 years؛ singleton pregnancy and low risk؛ without congenital abnormalities in the fetus؛ not suffering from mental illnesses and psychiatric disorders؛ not using drugs Psychedelic؛ not having any systemic diseases (diabetes, cardiovascular diseases, hypertension, etc.)؛ having minimal literacy؛ no indications for cesarean delivery؛ fear score higher than 85.
Exclusion criteria: unwillingness of mother and wife to participate in the study
Intervention groups
The first intervention group: cognitive behavioral therapy based on acceptance and commitment for pregnant mothers with the presence of their husbands
The second intervention group: cognitive behavioral therapy based on acceptance and commitment for pregnant mothers without the presence of their husbands
The third group: performing routine pregnancy care for the pregnant mother
Main outcome variables
Fear of childbirth, choosing the type of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240521061859N1
Registration date:2024-06-15, 1403/03/26
Registration timing:prospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
khadijeh hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3324 0298
Email address
khadijehhoseini54@gmail.com
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
The effect of Acceptance and Commitment therapy (ACT) with and without the presence of the spouse on the fear of childbirth and the choice of the type of childbirth in primigravida women
Public title
"Effect of ACT on the fear of childbirth and choosing the type of childbirth"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First time pregnant women with a gestational age of 28 to 32 weeks
Maternal age of 18 to 38 years
Singleton pregnancy and low risk
Without congenital abnormalities in the fetus
Not suffering from mental illnesses and psychiatric disorders
Not using drugs Psychedelic
Not having any systemic diseases (Diabetes, Cardiovascular diseases, Hypertension, etc.)
Having minimal literacy
No indications for cesarean delivery,
Fear score higher than 85.
Exclusion criteria:
Unwillingness of pregnant mother or wife to participate in the study
Age
From 18 years old to 38 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
This research is a randomized clinical trial on 108 participants who were randomly divided into two intervention (A and B) and one control (C) groups (36 people in each group). The method of assigning the intervention to people is randomly and by the method of randomized permutation blocks with random block sizes of 4, 6 and 8, using the table related to random permutations. The randomization list is prepared by a statistician. The intervention used in this research is allocated according to the randomized list by a person outside the study who is not aware of the research objectives and according to the corresponding codes in the sealed envelopes. The participants will be randomly placed in three control groups, intervention with the presence of the spouse and intervention without the presence of the spouse, using a computer software that assigns random numbers
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 Science
Street address
Ahvaz Jundishapur University of medical Science, Golestan, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2024-06-01, 1403/03/12
Ethics committee reference number
IR.AJUMS.REC.1403.112
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 score in Vijma's fear of childbirth questionnaire version A
Timepoint
Fear of childbirth score at the beginning of the study (before the start of the intervention) and immediately after the end of the intervention and 2 weeks after the end of the intervention
Method of measurement
Vijma's fear of childbirth questionnaire version A
Secondary outcomes
1
Description
Choosing the type of delivery
Timepoint
After the end of the intervention
Method of measurement
Patient self-report
Intervention groups
1
Description
First Intervention group(A: 8 counseling sessions of 90 minutes of acceptance and commitment therapy for 2 months (one session per week) (based on the protocol of acceptance and commitment therapy (ACT)) will be carried out by the researcher on the first intervention group (Primigravida's women with the presence of their husbands)
Category
Behavior
2
Description
Second Intervention group(B): 8 counseling sessions of 90 minutes of acceptance and commitment therapy for 2 months (one session per week) (based on the protocol of acceptance and commitment therapy (ACT)) will be carried out by the researcher on the second intervention group (primigravida's women without the presence of their spouses).
Category
Behavior
3
Description
Control group: Carrying out routine pregnancy care without the intervention of a consultative approach of acceptance and commitment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health medical centers of Ahvaz city
Full name of responsible person
Khadijeh Hoseini
Street address
Department of Nursing and Midwifery, Jondishapur University of Ahvaz, Golestan highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 917 774 7214
Email
khadijhoseini54@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences, Deputy of research and technology, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3373 8383
Email
itc@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
Khadijeh Hoseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Nursing and Midwifery, Jondishapur University of Ahvaz, Golestan highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3373 8383
Email
khadijhoseini54@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Faculty member, Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Nursing and Midwifery, Jondishapur University of Ahvaz, Golestan highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3314 0000
Email
minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Nursing and Midwifery, Jondishapur University of Ahvaz, Golestan highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3314 0000
Email
minairavani2004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available