The Comparison of the Effectiveness of Mindfulness-Based Childbirth and Parenting Program and Cognitive-Behavioral Therapy on Pregnancy Anxiety, Birth Satisfaction, Fear of normal delivery, and Labor Pain in Primiparous Women
Determining the effectiveness of mindfulness-based delivery and parenting program on pregnancy anxiety, fear of natural childbirth, labor pain and delivery satisfaction in nulliparous pregnant women
Design
After entering the questionnaire, the participants completed the demographic information questionnaire and after obtaining written consent from both the pregnant woman and her husband and in the absence of her father, randomly divided into two experimental groups and control are assigned
Settings and conduct
The allocation randomization is simple and uses a random number table. Random allocation concealment will also be done using the central randomization method.
Participants/Inclusion and exclusion criteria
Primiparous and monogamous pregnant women fluent in Persian have a normal and low-risk pregnancy and in the last month of the second or first trimester of pregnancy.
Tendency to have a normal birth in a hospital
Age 18 years and above
Ability to spend at least 12 weeks research period
BMI ≤ 30.1 in the first two months of pregnancy No history / current presence of severe psychiatric illness (psychotic disorders, mental disabilities, other disorders leading to hospitalization or use of psychiatric drugs) or alcohol or drug use,
Lack of experience doing continuous mind-body exercises
Exclusion criteria include converting the pregnancy to a high-risk pregnancy, having the intention and plan to have a cesarean section after entering the plan, requiring specific medical conditions of the mother or fetus that require termination of pregnancy before 37 weeks.
Having or needing to take psychiatric medication or starting to use alcohol and drugs after entering the course
Intervention groups
Cognitive-behavioral therapy group
Mindfulness-based delivery and parenting program group
Main outcome variables
Pregnancy anxiety - Fear of childbirth - Labor pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201009048974N1
Registration date:2021-01-25, 1399/11/06
Registration timing:retrospective
Last update:2021-01-25, 1399/11/06
Update count:0
Registration date
2021-01-25, 1399/11/06
Registrant information
Name
Maryam Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
maryam_bakhtiyari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-26, 1399/08/05
Expected recruitment end date
2020-11-25, 1399/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effectiveness of Mindfulness-Based Childbirth and Parenting Program and Cognitive-Behavioral Therapy on Pregnancy Anxiety, Birth Satisfaction, Fear of normal delivery, and Labor Pain in Primiparous Women
Public title
The Comparison of the Effectiveness of Mindfulness-Based Childbirth and Parenting Program and Cognitive-Behavioral Therapy on Pregnancy Anxiety, Birth Satisfaction, Fear of normal delivery, and Labor Pain in Primiparous Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant Women
Primiparous Women
Exclusion criteria:
psychosis
Hi risk pregnancy
Taking psychiatric medication
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the questionnaire, the participants completed the demographic information questionnaire and after obtaining written consent from both the pregnant woman and her husband and in the absence of her father, randomly divided into two experimental groups (cognitive behavioral therapy and delivery and parenting program based on Mindfulness) and control are assigned.
The allocation randomization is simple and uses a random number table. Random allocation concealment will also be done using the central randomization method. After assigning individuals to the groups, a pretest is performed for the variables of labor pain, pregnancy anxiety and fear of normal delivery for individuals in both groups. Then, mindfulness and cognitive-behavioral delivery and parenting programs are implemented for the experimental group.
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
Research Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.SBMU.MSP.REC.1398.665
Health conditions studied
1
Description of health condition studied
Pregnancy Anxiety, Birth Satisfaction, Fear of normal delivery, and Labor Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pregnancy Anxiety Score in PRAQ Questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
PRAQ Questionnaire
2
Description
Fear score of natural childbirth in Vijma childbirth expectation questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
Vijma childbirth expectation questionnaire
3
Description
Mindfulness score in the Five Facet Mindfulness Questionnaire and Multidimensional Assessment of Interoceptive Awareness questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
Five Facet Mindfulness Questionnaire and Multidimensional Assessment of Interoceptive Awareness questionnaire
4
Description
Visual analog scale of labor pain
Timepoint
during labor
Method of measurement
Score zero to 10 on the visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral therapy group. Cognitive-behavioral educational intervention in this study was based on appropriate cognitive-behavioral methods to reduce anxiety in pregnant women and programs set by the Ministry of Health during 12 sessions of 90 minutes and twice a week. It should be noted that each intervention session is organized by providing assignments and giving feedback to sample members and performing appropriate exercises, as well as a review of previous sessions.
Category
Treatment - Other
2
Description
Intervention group: Mindfulness-based childbirth and parenting program. Participants begin MBCP in the late second or early third trimester and are asked to listen to meditation guide CDs at home 30 minutes a day, 6 days a week. Formal mindfulness meditation instructions include sitting meditation, body monitoring, mindfulness pug, and couple meditation in sessions. These techniques are adapted to cover the mental and physical aspects of pregnancy.
Category
Treatment - Other
3
Description
Control group: General education of pregnancy and childbirth
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Ghiasi Hamed
Street address
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2243 9982
Email
Intl_office@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Abbas Masjedi Arani
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2243 9982
Email
taleghani@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Bakhtiari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2243 9982
Email
maryam_bakhtiyari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Bakhtiari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2243 9982
Email
maryam_bakhtiyari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Bakhtiari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - Shahid Chamran Highway - Yemen St. - Shahid Arabi St., next to Shahid Beheshti University of Medical Sciences, Ayatollah Taleghani Hospital, 4th floor, Department of Clinical Psychology
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2303 1548
Fax
+98 31 1114 1113
Email
maryam_bakhtiyari@sbmu.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