This study investigated the efficacy of acceptance and commitment therapy on the natural childbirth fear.
Design
This was randomized clinical trial in pregnant women who fear of normal childbirth. A total of 120 people were sampled through the "ُSIB" system as a telephone call and by convenient method. Pregnant women who wished to have a cesarean delivery completed the Hartmann Fear of Childbirth Questionnaire. Finally, 80 people had a fear of childbirth score above 28, of which 66 had all the criteria for inclusion in the study. Then 66 people were assigned into two groups of 33 intervention and control (parallel groups) by random block method "A" and "B" .
Settings and conduct
The ACT approach was implemented for the intervention group.The control group received just 8 sessions preparation childbirth classes intervention.Fear of childbirth was assessed immediately and one month after the intervention in 2 groups. In the next stage, the women of the two groups were followed up until delivery.Samples were selected from Khomein health centers and intervention was performed in delivery preparation classes of Khomein city hospital. The second phase of the study was performed in the postpartum ward of Khomein city hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: nulliparous; low risk pregnancy; 20-25 gestation weeks; single pregnancy; absence of a psychiatric or medical complications; being able to read and write; scoring 28 or higher on Harman's questionnaire.
Exclusion criteria: unwillingness to continue study; having 2 or more absences; any stressful condition during the study.
Intervention groups
Intervention group: the ACT intervention in eight weekly sessions. Control group: just 8 sessions preparation childbirth classes without ACT program.
Main outcome variables
The main outcomes included assessing the fear of childbirth, the experience of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190910044736N2
Registration date:2020-10-03, 1399/07/12
Registration timing:retrospective
Last update:2020-10-03, 1399/07/12
Update count:0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
Katayon Vakilian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
dr.kvakilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-09-11, 1398/06/20
Trial completion date
2020-03-20, 1399/01/01
Scientific title
The effect of acceptance and commitment therapy on fear of child birth experience
Public title
The effect of acceptance and commitment therapy on fear and child birth experience
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being pregnant and in the 20th to 25th gestation weeks
Nulliprous
Scoring 28 or higher on Harman's questionnaire
Being diagnosed as low risk pregnancy
Absence of a psychiatric disorder
Absence of medical complications during pregnancy
Being able to read and write and
Prefer to cesarean if they could opt
Exclusion criteria:
unwillingness to continue with the study at any point in time
Having 2 or more absences during the training classes
Presenting with any stressful condition or event during the study
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
This research is a randomized clinical trial on 66 participants who were randomly divided into two intervention groups (A and B) using a randomized block allocation method (block size= 4). After determining the assignment sequence by Excel software using the RAND formula, the sequences were sequentially written on papers and placed in opaque closed envelopes. The envelopes were sequentially numbered.pre-specified number of study assignments in random order.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij square, Sardasht region, Arak , Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-01-30, 1398/11/10
Ethics committee reference number
IR.ARAKMU.REC.1397.282
Health conditions studied
1
Description of health condition studied
Phobia disorder
ICD-10 code
F41.0
ICD-10 code description
Phobic anxiety disorder, unspecified
Primary outcomes
1
Description
Main outcome : Fear of natural childbirth, Childbirth experience
Timepoint
Fear of natural childbirth immediately after the intervention and one month later
Method of measurement
Harman's Childbirth Fear Questionnaire and Vakilian etal childbirth experience
Secondary outcomes
1
Description
Childbirth Self- Efficacy
Timepoint
Postpartum ward
Method of measurement
Childbirth Self- Efficacy inventory (CBSEI)
Intervention groups
1
Description
Intervention group: َcounseling sessions 8 sessions of 45-60 minutes of acceptance and commitment treatment for 2 months (one session per week) [according to the acceptance and commitment treatment protocol (ACT)) were performed by the researcher on the intervention group
Category
Behavior
2
Description
Control group: training in childbirth preparation classes 8 sessions without intervention Acceptance and commitment counseling approach
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health medical centers of Khomein city
Full name of responsible person
Fatemeh Rahmati
Street address
Medical School, Midwifery Department, Arak University of Medical Sciences, Basij square, Sardasht region, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
cattyv2002@yahoo.com
2
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Fatemeh Rahmati
Street address
Arak University of Medical Sciences, Basij square, Sardasht region, Arak , Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
rahmati_2016@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Analgesia Department, Medical School, َArak University of Medical Sciences, Basij square, Sardasht region, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3507
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
student of Master science
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Medical School, Arak University of Medical Sciences, Basij square, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3506
Email
rahmati_2016@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakilian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Medical School, Arak University of Medical Sciences, Basij square, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
dr.kvakilian@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakilian
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Medical School, Arak University of Medical Sciences, Basij square, Sardasht region
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
dr.kvakilian@arakmu.ac.ir
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
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available