Investigating the effect of cognitive counseling based on mindfulness (MBCT) on psychological well-being and choosing the type of delivery in pregnant women who referred to childbirth preparation classes at Ayatollah Taleghani Hospital in Ilam city in 2023
Investigating the effect of Mindfulness Based Cognitive Therapy (MBCT) on psychological well-being and choosing the type of delivery in pregnant women who referred to childbirth preparation classes
Design
The clinical trial has a control group, single-blind, randomized groups using Random Allocation Software.
Settings and conduct
The current research is a randomized controlled clinical trial (RCT) in which pregnant women referring to Ayatollah Taleghani Hospital in Ilam between October and December 2023 will participate, after obtaining the necessary permits and code of ethics From Ilam University of Medical Sciences, the plan will be registered in the clinical trials system and the RCT code will be obtained.
Participants/Inclusion and exclusion criteria
The age of the participant is between 20 and 40 years, the gestational age is more than 20 weeks, the mother is not addicted to drugs, the absence of abortion symptoms, the absence of hypertension or diabetes. Exit criteria: withdrawal of the participant and absence or not completing the sessions completely.
Intervention groups
While the control group will only receive regular pregnancy care, the experimental group will receive MBCT program training and attendance at pregnancy preparation classes during 8 sessions, each session lasting 90 minutes (twice a week).
Main outcome variables
Choosing the type of delivery; Psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221116056514N1
Registration date:2023-07-27, 1402/05/05
Registration timing:registered_while_recruiting
Last update:2023-07-27, 1402/05/05
Update count:0
Registration date
2023-07-27, 1402/05/05
Registrant information
Name
Elham Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3331 4441
Email address
alizadeh.elham2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cognitive counseling based on mindfulness (MBCT) on psychological well-being and choosing the type of delivery in pregnant women who referred to childbirth preparation classes at Ayatollah Taleghani Hospital in Ilam city in 2023
Public title
Investigating the effect of cognitive counseling based on mindfulness (MBCT) on psychological well-being and choosing the type of delivery in pregnant women who referred to childbirth preparation classes at Ayatollah Taleghani Hospital in Ilam city in 2023
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the participant is between 20 and 40 years old
The gestational age is more than 20 weeks
Absence of drug addiction in the mother
Not having abortion symptoms
Absence of high blood pressure or diabetes
Exclusion criteria:
Participant withdrawal
Absence or not completing meetings completely
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After preparing a general list of clients, using Random Allocation Software for Clinical Trials, people are randomly selected in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this one-way blind study, one of these groups is blinded to the intervention.
Which of the groups should be blinded depends on the type of study, the sample under study or the disease in question and even the type of intervention used. In this study, the participant group was blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Beheshti Street, Correspondent Boulevard, next to Iran Khodro
City
Ilam
Province
Ilam
Postal code
6931975397
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.MEDILAM.REC.1401.132
Health conditions studied
1
Description of health condition studied
Type of delivery
ICD-10 code
O82.1
ICD-10 code description
Delivery by emergency caesarean section
Primary outcomes
1
Description
Psychological well-being
Timepoint
Examination of psychological well-being before the intervention, 4 weeks of training (intervention), 2 weeks later re-examination
Method of measurement
After the completion of the meetings and compliance with the criteria for exiting the research during the entire process of holding the meetings, in the last stage of the research questionnaires will be distributed between both experimental and control groups and the data will be collected and analyzed in SPSS software and the results will be obtained. They will be registered.
2
Description
Choice of delivery type
Timepoint
8 sessions and each session is 90 minutes (twice a week)
Method of measurement
After the completion of the meetings and compliance with the criteria for exiting the research during the entire process of holding the meetings, in the last stage of the research questionnaires will be distributed between both experimental and control groups and the data will be collected and analyzed in SPSS software and the results will be obtained. They will be registered.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: MBCT therapy sessions will be held according to Kabat-Zinn et al. protocol (Kabat-Zinn et al., 1992) and pregnancy preparation classes in 8 90-minute sessions (two sessions per week). 1) Description of cognitive therapy intervention sessions Behavior based on mindfulness 1) The first session of cognitive therapy based on the presence of mind, setting a general policy taking into account the aspect of confidentiality and personal life of people, inviting people to introduce themselves to each other, practicing physical examination, homework, discussion and setting weekly meetings. , the distribution of tapes and pamphlets will be. 2) The second session will include training for 14 groups of muscles, including forearms, arms, calf muscles, thighs, stomach, chest, shoulders, neck, lips, eyes, and forehead. 3) The third session Relaxed tone for six groups of muscles, including hands and arms, legs and thighs, stomach and chest, forehead and lips, and relaxed tone homework will be training. Inhaling and exhaling with relaxation and without thinking about anything else and teaching the technique of watching breathing and setting the home task of mindfulness of breathing before sleep will be dedicated. Their movements and search for physical sensations, and the homework assignment will be eating mindfulness. 6) The sixth session, training to pay attention to the mind, positive and negative thoughts, whether the thoughts are pleasant or unpleasant, allowing negative and positive thoughts to enter the mind and It will be as easy as removing them from the mind without judgment and paying deep attention to them. 7) The seventh session will include 40 minutes of sitting meditation, reviewing homework, and practicing observing the connection between activity and creation. 8) The eighth session, past materials. It will be a review and summary. 2) Description of the preparation sessions during pregnancy. The first session: In this session, which is held in the 20th to 23rd week of pregnancy, you will get to know the objectives and principles of the classes and how to conduct the classes. You will also learn about the female reproductive system and the names and functions of some organs that are involved in the process of pregnancy and childbirth, personal hygiene, adapting to the physiological changes during pregnancy. You will get to know the common complaints and how to deal with them and you will get to know the skeletal and stretching exercises, breathing and relaxation and you can do the exercises after the session. The second session: In this session, which is held during the 24th to 27th week of pregnancy, you will learn about nutrition during pregnancy, distribution of the food pyramid, correction of posture, skeletal stretching exercises, breathing and relaxation, and after the session you can Do the exercises. Third meeting: This meeting is held in the 28th to 29th week of pregnancy. In this session, you and your wife will learn about mental health, the role of the spouse, changes in mood during pregnancy and the growth and development of the fetus, how to communicate with the fetus and correct the position of courtship, skeletal stretching exercises, breathing and relaxation, and after the session you will You can do the exercises. Fourth session: This session is held in the 30th to 31st week of pregnancy. warning signs/diagnosis of normal and abnormal pains during pregnancy, bleeding * spotting * headache * fetal movements * discharge * rupture of amniotic sac * swelling of hands and feet * correction of the position during pregnancy * skeletal and muscular exercises * in this session you will have nutrition and You will get to know maintaining a proper diet, how to take supplements, childbirth and pain reduction methods, stretching exercises, breathing and relaxed tone, and after the session you can do the exercises. Fifth session: This session is held at 32-33 weeks of pregnancy. It is possible to plan for childbirth/choose the type of childbirth/various methods of pain reduction and anesthesia in the childbirth process/choose the place of childbirth and the necessary equipment for childbirth/visiting the delivery room of a hospital if possible/correcting the situation during pregnancy/skeletal and muscular exercises / Breathing exercises and calmness of the sixth session: This session is held at 34-35 weeks of pregnancy. Familiarity with the process and symptoms of labor pain / Familiarity with the first, second and third stages of labor and how to take care of yourself in each of the stages of labor / The role of pregnancy hormones in the stages of labor / Adapting to the pain of labor / Showing a video or animation of labor / Correcting the situation in pregnancy / Skeletal and muscular exercises/breathing and relaxation exercises, seventh session: This session is held at the 36th week of pregnancy. Postpartum health and care/postpartum warning signs/postpartum grief and depression/breastfeeding training/postpartum exercises/correction of posture during pregnancy/squatting and muscle exercises/breathing and relaxation exercises Eighth session: This session is held in the 37th week of pregnancy. Baby hygiene with an emphasis on the general characteristics of the baby at birth and during the newborn period / Baby care (how to bathe and change clothes, etc.) / Breastfeeding training / Danger signs for the baby / Showing the video of breastfeeding and baby care / Modification Position in pregnancy/skeletal and muscular exercises/breathing exercises and relaxation
Category
Behavior
2
Description
Control group: Control group: The control group will receive only the usual pregnancy care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Elham Alizadeh
Street address
Shahid Beheshti St., Correspondent Blvd., next to Iran Khodro
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3337 2708
Email
alizadeh.elham2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abbas Maleki
Street address
Ilam, Bangajab, Ilam University of Medical Sciences campus, Research and Technology Blvd
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5724
Email
vcr@medilam.ac.ir
Grant name
Vice President of Research and Technology, Ilam University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Elham Alizadeh
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti St., Correspondent Blvd., next to Iran Khodro
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3337 2708
Email
alizadeh.elham2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Elham Alizadeh
Position
midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti St., Correspondent Blvd., next to Iran Khodro
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3337 2708
Email
alizadeh.elham2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Elham Alizadeh
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti St., Correspondent Blvd., next to Iran Khodro
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3337 2708
Email
alizadeh.elham2@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
"No more information"
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There are no plans to publish documentation or data files.
When the data will become available and for how long
There are no plans to publish documentation or data files.
To whom data/document is available
There are no plans to publish documentation or data files.
Under which criteria data/document could be used
There are no plans to publish documentation or data files.
From where data/document is obtainable
There are no plans to publish documentation or data files.
What processes are involved for a request to access data/document
There are no plans to publish documentation or data files.