Effects of Yoga and Meditation on The Birth Process
Primary Purpose
Birth, First, Labor Pain, State Anxiety
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
yoga and meditation
Birth preparation training
Sponsored by
About this trial
This is an interventional supportive care trial for Birth, First focused on measuring Labour Preparation Class, Labour Support, Meditation, Pregnancy Yoga
Eligibility Criteria
Inclusion Criteria:
- Pregnant women,
- Primiparous and between 20-36 gestational weeks,
- Single fetuses, expected to give birth normally and spontaneously,
- No pregnancy complications and systemic disease,
- Speak Turkish
Exclusion Criteria:
- Being unable to speak Turkish
- Having a history of serious illness that threatens life or because of these reasons.
- Currently or previously due to a serious mental weakness or illness
- Being diagnosed with a psychiatric diagnosis and being treated for this reason,
- Being multiparous,
- Multiple pregnancies, being in the gestational week less than 20 weeks and greater than 36 weeks,
- Having a diagnosis that constitutes an obstacle to physical activity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
The Study Group
Control Group
Arm Description
Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day.
The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.
Outcomes
Primary Outcome Measures
Characteristics of Labor (Pregnant)
The Introductory Information Form, which consisted of 8 questions (socio-demographic data) and pregnancy characteristics (12 questions) of pregnant women, and which was prepared in line with the sources, was used.
Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group
The Visual Analog Scale (VAS) consists of a line, often 10 cm long, with verbal anchors at either end, (e.g.,"no pain" on the far left and "the most intense pain imaginable" on the far right). The scale takes a minimum of 0 and a maximum of 10, and higher scores mean a worse result. Visual Analogue Scale (VAS) was used to assess the pains during the birth process of the pregnant women in both the study and control groups.Two ends of the parameter to be evaluated at the two ends of a 100 mm line in VAS the definition is written and the pregnant woman is asked to indicate on this line where her condition is appropriate by drawing a line or putting a dot or pointing. For example, I have no pain at all at one end for pain, very severe pain is written on the other end, and the patient marks his current state on this line. The length of the distance from the place where there is no pain to the place marked by the patient indicates the patient's pain.
Secondary Outcome Measures
Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups
the WIJMA Delivery Expectancy/Experience Questionnaire A, was applied once during the study after the 28th week of pregnancy in preparation for childbirth. Wijma Delivery Expectancy/Experience Questionnaire Version B (W-DEQ B) and was applied in the 4th hour on average after the birth event.W-DEQ A: responses on the 33-point scale numbered from 0 to 5 it is a six-bit likert-type scale. 0 is expressed as" completely "and 5 as" never". The minimum score that can be taken from the scale is 0, while the maximum score is 165. High scores indicate that the fear of childbirth experienced by women is high.W-DEQ B: the scale consists of 32 substances. In scale responses are numbered from 0 to 5 and are of six likert type. 0 is expressed as" completely "and 5 as" never". The minimum score on the scale is 0, while the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases.
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups
The Childbirth Self-Efficacy Scale Short Form was applied twice as the short form to the study and control group during the study. After the start of birth preparation training, when the pregnant women were in the 28th week, after the application of other forms, it was applied as a pre-test and as a post-test at a time when the pregnant women were appropriate. The lowest score, which can be obtained from the lower dimensions of the scale, is 32, and the highest score is 320 points. A high score to be taken from each lower dimension is related to the birth of pregnant women it shows that the expectation of qualification and results is high. As the scores rise it is determined that it increases self-sufficiency.
Full Information
NCT ID
NCT04883541
First Posted
April 17, 2021
Last Updated
August 6, 2021
Sponsor
Uskudar University
Collaborators
Biruni University
1. Study Identification
Unique Protocol Identification Number
NCT04883541
Brief Title
Effects of Yoga and Meditation on The Birth Process
Official Title
Assistant Professor,Faculty of Health Sciences Department of Midwifery, Uskudar University, Istanbul, Turkey
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University
Collaborators
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Introduction: Today it is seen that women lose their birthing strength, give the control to healthcare personnel during labour and the rate of c-section or interventional labour is increasing. For this reason, the importance of yoga, meditation and breath awareness practices increases during pregnancy and birth. The study was carried out as a randomized control trial with the purpose of examining the impact of yoga and meditation during pregnancy and labour on the labour process.
Methods: The study was completed with 90 primiparous pregnant women in total, 30 in experimental group and 60 in control group. The data was collected using State Trait Anxiety Inventory, Wijma Delivery Expectancy/Experience Questionnaire A, The Childbirth Self-Efficacy Scale Short Form, Wijma Delivery Expectancy/Experience Questionnaire Version B and Visual Analogue Scale. Pregnant women in experimental group did yoga and meditation for 60 minutes 2 times a week for 10 weeks. Innatal period yoga and meditation practices were continued in experimental group during labour.
Detailed Description
METHODS
Study design:
The present study was conducted as a randomized controlled study. The study was conducted on pregnant women who applied to the pregnancy school of an educational and research hospital on the Anatolian side of Istanbul province between October 2016 and May 2018, and who met the criteria for acceptance of the study.
Setting and samples:
All pregnant women attending the pregnancy school, who agreed to participate in the research, and met the research conditions within the study dates constituted the research population. The sampling of the study was created with the simple random method as the experiment and control group with individuals who met the criteria of the study and who were accepted to participate. In this respect, pregnant women, who were primiparous and between 20-36 gestational weeks, who had single fetuses, expected to give birth normally and spontaneously, with no pregnancy complications and systemic disease, and who could speak Turkish, were included in the study. Power Analysis was made by using the G*Power (v3.1.7) Program to determine the sampling number of the study. According to Cohen's effect size coefficients and other calculations, it was assumed that the evaluations between the two independent groups would have a large impact size (d=0.50). It was also decided that there should be at least 26 people in the groups, and considering that there might be losses in the study process, 30 people were included in the experimental group, and 60 people in the control group, making 90 people in total.
For Randomization, when the experiment and control group were created, support was received from pregnancy school instructors and groups, and pregnant women were determined by using the method of envelope selection. Pregnancy school instructors asked the group volunteering to participate in the study to independently choose one of two blue or red colored envelopes. Those who chose the blue envelope formed the experiment group, and those that chose the red envelope were taken into the control group. The envelope selection process continued until the desired numbers were reached. The researcher was told advised of the groups to which subjects were included by the pregnancy school instructor only after the subjects were chosen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth, First, Labor Pain, State Anxiety, Self Efficacy
Keywords
Labour Preparation Class, Labour Support, Meditation, Pregnancy Yoga
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The present study was conducted as a randomized controlled study.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
For Randomization, when the experiment and control group were created, support was received from pregnancy school instructors and groups, and pregnant women were determined by using the method of envelope selection. Pregnancy school instructors asked the group volunteering to participate in the study to independently choose one of two blue or red colored envelopes. Those who chose the blue envelope formed the experiment group, and those that chose the red envelope were taken into the control group. The envelope selection process continued until the desired numbers were reached. The researcher was told advised of the groups to which subjects were included by the pregnancy school instructor only after the subjects were chosen.
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Study Group
Arm Type
Experimental
Arm Description
Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.
Intervention Type
Behavioral
Intervention Name(s)
yoga and meditation
Intervention Description
The pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation.
Intervention Type
Behavioral
Intervention Name(s)
Birth preparation training
Intervention Description
The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.
Primary Outcome Measure Information:
Title
Characteristics of Labor (Pregnant)
Description
The Introductory Information Form, which consisted of 8 questions (socio-demographic data) and pregnancy characteristics (12 questions) of pregnant women, and which was prepared in line with the sources, was used.
Time Frame
16 hours
Title
Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group
Description
The Visual Analog Scale (VAS) consists of a line, often 10 cm long, with verbal anchors at either end, (e.g.,"no pain" on the far left and "the most intense pain imaginable" on the far right). The scale takes a minimum of 0 and a maximum of 10, and higher scores mean a worse result. Visual Analogue Scale (VAS) was used to assess the pains during the birth process of the pregnant women in both the study and control groups.Two ends of the parameter to be evaluated at the two ends of a 100 mm line in VAS the definition is written and the pregnant woman is asked to indicate on this line where her condition is appropriate by drawing a line or putting a dot or pointing. For example, I have no pain at all at one end for pain, very severe pain is written on the other end, and the patient marks his current state on this line. The length of the distance from the place where there is no pain to the place marked by the patient indicates the patient's pain.
Time Frame
the 4th hour on average after the birth
Secondary Outcome Measure Information:
Title
Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups
Description
the WIJMA Delivery Expectancy/Experience Questionnaire A, was applied once during the study after the 28th week of pregnancy in preparation for childbirth. Wijma Delivery Expectancy/Experience Questionnaire Version B (W-DEQ B) and was applied in the 4th hour on average after the birth event.W-DEQ A: responses on the 33-point scale numbered from 0 to 5 it is a six-bit likert-type scale. 0 is expressed as" completely "and 5 as" never". The minimum score that can be taken from the scale is 0, while the maximum score is 165. High scores indicate that the fear of childbirth experienced by women is high.W-DEQ B: the scale consists of 32 substances. In scale responses are numbered from 0 to 5 and are of six likert type. 0 is expressed as" completely "and 5 as" never". The minimum score on the scale is 0, while the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases.
Time Frame
the 4th hour on average after the birth
Title
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups
Description
The Childbirth Self-Efficacy Scale Short Form was applied twice as the short form to the study and control group during the study. After the start of birth preparation training, when the pregnant women were in the 28th week, after the application of other forms, it was applied as a pre-test and as a post-test at a time when the pregnant women were appropriate. The lowest score, which can be obtained from the lower dimensions of the scale, is 32, and the highest score is 320 points. A high score to be taken from each lower dimension is related to the birth of pregnant women it shows that the expectation of qualification and results is high. As the scores rise it is determined that it increases self-sufficiency.
Time Frame
the 4th hour on average after the birth
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women,
Primiparous and between 20-36 gestational weeks,
Single fetuses, expected to give birth normally and spontaneously,
No pregnancy complications and systemic disease,
Speak Turkish
Exclusion Criteria:
Being unable to speak Turkish
Having a history of serious illness that threatens life or because of these reasons.
Currently or previously due to a serious mental weakness or illness
Being diagnosed with a psychiatric diagnosis and being treated for this reason,
Being multiparous,
Multiple pregnancies, being in the gestational week less than 20 weeks and greater than 36 weeks,
Having a diagnosis that constitutes an obstacle to physical activity
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
JOURNAL EDITOR AND REFEREES TO BE PUBLISHED
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Links:
URL
http://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
Description
Akarsu RH. The effect of pregnancy yoga on the psychosocial health level of pregnant women and prenatal attachment [PhD dissertation],. T.C. Istanbul University, Institute of Health Sciences, Department of Women's Health and Diseases Nursing, Women
URL
http://fnjn.org/en/type-of-delivery-time-of-initial-breastfeeding-and-skin-to-skin-contact-of-pregnant-women-participating-in-childbirth-preparation-education-13668
Description
Esencan TY, Karabulut Ö, Yıldırım AD, Abbasoğlu DE, Külek H. et. al. Type of delivery, time of ınitial breastfeeding, and skin-to-skin contact of pregnant women participating in childbirth preparation education. Florence Nightingale Journal of Nursi
Available IPD and Supporting Information:
Available IPD/Information Type
PhD thesis
Available IPD/Information URL
http://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
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Effects of Yoga and Meditation on The Birth Process
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