The effect of mindfulness on labor pain in primiparous women referred to Kashan Shahid Beheshti Hospital
Design
This study is a randomized controlled trial with parallel design. Sample size is 112 persons. Samples will be randomly assigned to control and intervention groups using 4-block design.
Settings and conduct
This study will be carried out at Kashan Shahid Beheshti Hospital. Pregnant women will be trained in delivery preparation classes. 6.8 -10 cm and episiotomy time in both groups will be assessed using pain ruler and McGill questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria are nulliparous, gestational age between 20-23 weeks, age 18-35 year, singleton pregnancy, having secondary school education. Exclusion criteria are high risk pregnancy based on protocol of integrated health mother’s care, having experiences in mediation and yoga, psychological and emotional and physical illness, consumption of drug, elective c/s.
Intervention groups
The intervention group will receive 8 training sessions that are mind-based content, along with routine care in the delivery preparation classes, and the control group will receive the delivery preparation classes.
Main outcome variables
Evaluation of severity of labor pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045660N1
Registration date:2020-01-15, 1398/10/25
Registration timing:prospective
Last update:2020-01-15, 1398/10/25
Update count:0
Registration date
2020-01-15, 1398/10/25
Registrant information
Name
zeinab hasanimotlagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5522 7504
Email address
z.hasanimotlagh72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness on labor pain in primiparous women
Public title
The effect of mindfulness on labor pain in primiparous women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
- Primiparous Pregnant Women, from Week 20 to 23
Having at least a third-grade guidance degree
Age range 18 to 35 years
Single pregnancy
Exclusion criteria:
High-risk pregnancy (based on Integrated Maternal Health Care Booklet)
Experience with meditation and yoga
Known mental illnesses and drug use
Scheduled cesarean birth
- Any need for emergency intervention in the mother and fetus in cases such as bleeding, tandem contractions, accelerated labor, fetal distress, premature placental abruption, cesarean section
Normal contraindications (placenta previa, pelvic stenosis, no fetal rotation)
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to the control and intervention groups using a four-block design using a coin throw.
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 qazvin university of medical sciences
Street address
Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2019-11-04, 1398/08/13
Ethics committee reference number
IR.QUMS.REC.1398.178
Health conditions studied
1
Description of health condition studied
Intensity of labor pain in active phase
ICD-10 code
000-099
ICD-10 code description
pregnancy,childbirth and the pureperium
Primary outcomes
1
Description
The severity of labor pain in two groups
Timepoint
after admission the severity of pain at 4, 6,8,10 and in second stage and when laceration or episiotomy .
Method of measurement
In the study of the effect of mindfulness on labor pain, how variable measure can be visual analogue scale and McGill questionnaire.
Secondary outcomes
1
Description
Measuring the length of the first, second and third stages of labor
Timepoint
In the study of the effect of mindfulness on labor pain in primiparous women, the timing of measuring the length of the first, second and third stages of labor can be during the active phase of labor and postpartum.
Method of measurement
In studying the effect of mindfulness on labor pain in primiparous women, how the secondary variable measuring the length of the first, second and third stages of labor can be measured in minutes and hours.
2
Description
The severity of episiotomy pain
Timepoint
In the study of the effect of mindfulness on labor pain in primiparous women, time periods of measuring the severity of episiotomy pain may be postpartum and undergoing episiotomy repair.
Method of measurement
In studying the effect of mindfulness on labor pain in primiparous women, how to measure secondary variable of severity of pain can be McGill questionnaire and visual analogue scale .
3
Description
The amount of analgesia used
Timepoint
In the study of the effect of mindfulness on labor pain in primiparous women, time periods are measured to measure the amount of analgesic drug use throughout the labor stages.
Method of measurement
In the study of the effect of mindfulness on labor pain in primiparous women, how to measure the secondary variable of analgesic drug use can be case study and question.
Intervention groups
1
Description
Intervention group: There are 56 pregnant women in this group who will receive routine pregnancy care and childbirth preparation classes + 8 mindfulness training sessions.
Category
Behavior
2
Description
Control group: 56 Pregnant women are in this group who will receive routine pregnancy care and childbirth preparation classes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Mohammad Reza Sharif
Street address
Kashan 5 km Ravand Road, Qotb Ravandi Boulevard, Shahid Dr. Beheshti Hospital Complex
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
zeinabhasanimotlagh
Position
midwifer
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar Boulevard. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
(5-33336001) (28)
Email
z.hasanimotlagh72@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
zeinab hasani motlagh
Position
midwifer
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar Boulevard. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
(5-33336001) (28)
Email
z.hasanimotlagh72@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
zeinab hasanimotlagh
Position
midwifer
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar Boulevard. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
5-33336001) (28)
Email
z.hasanimotlagh72@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data related to the primary and secondary outcomes can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutes and research students in this field.
Under which criteria data/document could be used
It is permissible to use results in articles and compare them in new work.