Investigating the effect of mindfulness training on the pain intensity of natural childbirth of primiparous women: A randomized controlled clinical trial study
Determining the effect of mindfulness training on the pain intensity of normal delivery of primiparous women covered by the Agh Qala health and treatment network, in 2024
Design
This study is a randomized clinical trial with a control group. The samples of this study will be selected using the information recorded in the electronic record of pregnant women in the Nab system (health information software). After receiving the informed consent, 76 eligible pregnant women will be assigned to the intervention (N=38) and control (N=38) groups using the block randomization method of 4 groups.
Settings and conduct
The study population includes The study population includes all primiparous pregnant women covered by comprehensive health services centers of urban and rural in Agh Qala.The samples include pregnant women eligible for the study. The place of conducting this research is in comprehensive health service centers and the measurement of pain intensity is done in Al Jalil Agh Qala Hospital. Midwives measuring pain intensity in the hospital and epidemiologists analyzing the results are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Low-risk pregnancy, single fetus, desire for vaginal delivery
Exclusion criteria:
Reluctance to continue participating in the study, having a severe medical illness, participating in any individual or group psychotherapy classes during the study, terminating the pregnancy by cesarean section
Intervention groups
Intervention group: Mindfulness in 8 group counseling sessions
Control group: Routine care and training
Main outcome variables
The intensity of labor pain, will be measured using VAS (visual analog Scale) during 3 times (patient's entry to the maternity ward, 7 to 8 cm dilatation, the beginning of the second stage of labor) by the midwife colleague of the maternity ward.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240620062188N1
Registration date:2024-07-09, 1403/04/19
Registration timing:prospective
Last update:2024-07-09, 1403/04/19
Update count:0
Registration date
2024-07-09, 1403/04/19
Registrant information
Name
Akram Makin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3233 7720
Email address
elahemakin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mindfulness training on the pain intensity of natural childbirth of primiparous women: A randomized controlled clinical trial study
Public title
The effect of mindfulness training on labor pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women of reproductive age (10-54 years)
Low risk pregnancy
Single fetus, alive and healthy
Being in the second trimester of pregnancy
Desire for normal delivery
Exclusion criteria:
Passing mindfulness courses
Participating in childbirth preparation classes
High risk pregnancy including: preterm labor, placental abnormality, multiple births, the need for absolute rest prescribed by a midwife or doctor.
The woman and her husband have a known mental illness, the use of psychiatric drugs or incurable physical diseases (cancers) and chronic diseases during the last two months.
Use of drugs, psychedelics and alcohol
Experiencing a severe stressful event within the past 3 months
Age
From 10 years old to 54 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in this study will be assigned to two intervention (B) and control (A) groups using Block Randomization. In this way, using a dice that has 6 sides, the samples will be assigned to their groups. A number is written on each side, and each number is assigned to one of the blocks in the table, which shows its own state. Group A (routine care) and B (mindfulness training).
The complete list of randomized blocks will be provided to the principal investigator by the study epidemiology consultant.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in this study is single blinding. So that the pregnant woman knows which study group she will be in, but the investigator will not know the type of study group of the pregnant woman. The method of blinding will be in such a way that the midwife of labor part, who is not aware of the study process and the type of group of participants in the study, will measure the pain intensity of pregnant women on 3 occasions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
The effect of mindfulness training on the severity of labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
severity of labor pain
Timepoint
During 3 times (patient's entry to the maternity ward - 7 to 8 cm dilatation - beginning of the second stage of labor)
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
8 mindfulness group training sessions based on the protocol are held weekly for 90 minutes in the second trimester of pregnancy for 38 pregnant women by the researcher in person.
Category
Other
2
Description
Control group: routine care and training of comprehensive health service center
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
comprehensive health service center
Full name of responsible person
Asieh Sadat Baniaghil
Street address
Golestan University of Medical sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 6900
Fax
+98 17 3245 1353
Email
baniaghil@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges beigom Mir behbahani
Street address
Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 6900
Fax
+98 17 3245 1353
Email
baniaghil@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Asieh Sadat Baniaghil
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 6900
Email
bniaghil@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Asieh Sadat baniaghil
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 6900
Email
Baniaghil@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Asieh Sadat Baniaghil
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3245 6900
Email
bniaghil@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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available