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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
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    April 17, 2021
    Last Updated
    August 6, 2021
    Sponsor
    Uskudar University
    Collaborators
    Biruni University
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    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
    Citations:
    Citation
    Dick-Read G. Childbirth Without Fear: The Principles and Practice of Natural Childbirth. Second edition. UK: Pinter & Martin Ltd; 2013. 56-100.
    Results Reference
    background
    Citation
    Rathfisch G. Natural Philosophy of Birth. Istanbul: Nobel Medical Bookstores; 2012.
    Results Reference
    background
    Citation
    Öner N, LeCompte A. State Trait Anxiety Inventory Handbook, Istanbul; Boğaziçi University Publications;1983.
    Results Reference
    background
    Citation
    Lecompte A, Öner N. A study on the adaptation and standardization of the state-trait anxiety inventory to Turkish. IX. National Psychiatry and Neurological Sciences Congress Studies 1975;457-462.
    Results Reference
    background
    Citation
    Erkaya R, Karabulutlu Ö, Çalıka YK. Defining childbirth fear and anxiety levels in pregnant women procedia. Social and Behavioral Sciences 2017; 237:1045-1052.
    Results Reference
    background
    Citation
    Gönenç İM, Çakırer-Çalbayram N. Contributions of pregnancy school program, opinions of women on the education and their post-education experiences. Journal of Human Sciences 2017; 14(2), 1609-1620. doi:10.14687/jhs.v14i2.4424.
    Results Reference
    background
    Citation
    Çiçek Ö, Okumuş H. Doğumda öz-yeterlilik algisi: önemi ve etkileyen faktörler, Self-Efficacy perception at birth: its importance and effective factors. International Refereed Journal Ofgynaecological Diseases And Maternal Child Health 2017; 35-49.
    Results Reference
    background
    Citation
    Greathouse, K. The Nightmare of childbirth: the prevalence and predominant predictor variables for tokophobia in American women of childbearing age [PhD dissertation],. The School of Professional Psychology, Chicago; 2014.
    Results Reference
    background
    Citation
    Maharana S, Nagarathna R, Padmalatha V, Nagendra HR, Hankey A. The Effect of Integrated Yoga on Labor Outcome: A Randomized Controlled Study. International Journal of Childbirth 2013;(3):165-77. DOI: 10.1891 / 2156-5287.3.3.165.
    Results Reference
    background
    Citation
    Karakuş A, Şahin NH. The attitudes of women toward mode delivery after childbirth. International Journal of Nursing and Midwifery 2011; 3(5): 60-65. https://doi.org/10.5897/IJNM.9000042.
    Results Reference
    background
    Citation
    Salomonsson B. Fear is in the air : Midwives´ perspectives of fear of childbirth and childbirth self-efficacy and fear of childbirth in nulliparous pregnant women [PhD dissertation], Linköping University Medical Dissertations, Sweden, 2012; ISBN 978-91-7519-780-7 ISSN 0345-0082.
    Results Reference
    background
    PubMed Identifier
    26656473
    Citation
    Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.
    Results Reference
    result
    PubMed Identifier
    15544978
    Citation
    Simkin P, Bolding A. Update on nonpharmacologic approaches to relieve labor pain and prevent suffering. J Midwifery Womens Health. 2004 Nov-Dec;49(6):489-504. doi: 10.1016/j.jmwh.2004.07.007.
    Results Reference
    result
    PubMed Identifier
    24742636
    Citation
    Steel A, Adams J, Sibbritt D, Broom A, Frawley J, Gallois C. Relationship between complementary and alternative medicine use and incidence of adverse birth outcomes: an examination of a nationally representative sample of 1835 Australian women. Midwifery. 2014 Dec;30(12):1157-65. doi: 10.1016/j.midw.2014.03.015. Epub 2014 Mar 29.
    Results Reference
    result
    PubMed Identifier
    26551176
    Citation
    Polis RL, Gussman D, Kuo YH. Yoga in Pregnancy: An Examination of Maternal and Fetal Responses to 26 Yoga Postures. Obstet Gynecol. 2015 Dec;126(6):1237-1241. doi: 10.1097/AOG.0000000000001137.
    Results Reference
    result
    PubMed Identifier
    9638601
    Citation
    Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
    Results Reference
    result
    PubMed Identifier
    22260727
    Citation
    Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
    Results Reference
    result
    PubMed Identifier
    8502766
    Citation
    Lowe NK. Maternal confidence for labor: development of the Childbirth Self-Efficacy Inventory. Res Nurs Health. 1993 Apr;16(2):141-9. doi: 10.1002/nur.4770160209.
    Results Reference
    result
    PubMed Identifier
    16129013
    Citation
    Ip WY, Chan D, Chien WT. Chinese version of the Childbirth Self-efficacy Inventory. J Adv Nurs. 2005 Sep;51(6):625-33. doi: 10.1111/j.1365-2648.2005.03548.x.
    Results Reference
    result
    PubMed Identifier
    25119342
    Citation
    Korukcu O, Bulut O, Kukulu K. Psychometric Evaluation of the Wijma Delivery Expectancy/Experience Questionnaire Version B. Health Care Women Int. 2016;37(5):550-67. doi: 10.1080/07399332.2014.943838. Epub 2014 Oct 8.
    Results Reference
    result
    PubMed Identifier
    2197679
    Citation
    Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
    Results Reference
    result
    PubMed Identifier
    26104997
    Citation
    Stoll K, Edmonds JK, Hall WA. Fear of Childbirth and Preference for Cesarean Delivery Among Young American Women Before Childbirth: A Survey Study. Birth. 2015 Sep;42(3):270-6. doi: 10.1111/birt.12178. Epub 2015 Jun 24.
    Results Reference
    result
    PubMed Identifier
    25976219
    Citation
    Sydsjo G, Blomberg M, Palmquist S, Angerbjorn L, Bladh M, Josefsson A. Effects of continuous midwifery labour support for women with severe fear of childbirth. BMC Pregnancy Childbirth. 2015 May 15;15:115. doi: 10.1186/s12884-015-0548-6.
    Results Reference
    result
    PubMed Identifier
    26028282
    Citation
    Campbell VR, Nolan M. A qualitative study exploring how the aims, language and actions of yoga for pregnancy teachers may impact upon women's self-efficacy for labour and birth. Women Birth. 2016 Feb;29(1):3-11. doi: 10.1016/j.wombi.2015.04.007. Epub 2015 May 29.
    Results Reference
    result
    PubMed Identifier
    23952169
    Citation
    Salomonsson B, Gullberg MT, Alehagen S, Wijma K. Self-efficacy beliefs and fear of childbirth in nulliparous women. J Psychosom Obstet Gynaecol. 2013 Sep;34(3):116-21. doi: 10.3109/0167482X.2013.824418.
    Results Reference
    result
    PubMed Identifier
    15865489
    Citation
    Narendran S, Nagarathna R, Narendran V, Gunasheela S, Nagendra HR. Efficacy of yoga on pregnancy outcome. J Altern Complement Med. 2005 Apr;11(2):237-44. doi: 10.1089/acm.2005.11.237.
    Results Reference
    result
    PubMed Identifier
    25535930
    Citation
    Jiang Q, Wu Z, Zhou L, Dunlop J, Chen P. Effects of yoga intervention during pregnancy: a review for current status. Am J Perinatol. 2015 May;32(6):503-14. doi: 10.1055/s-0034-1396701. Epub 2014 Dec 23.
    Results Reference
    result
    PubMed Identifier
    26297372
    Citation
    Cramer H, Frawley J, Steel A, Hall H, Adams J, Broom A, Sibbritt D. Characteristics of women who practice yoga in different locations during pregnancy. BMJ Open. 2015 Aug 21;5(8):e008641. doi: 10.1136/bmjopen-2015-008641.
    Results Reference
    result
    PubMed Identifier
    25710094
    Citation
    Sharma M, Branscum P. Yoga interventions in pregnancy: a qualitative review. J Altern Complement Med. 2015 Apr;21(4):208-16. doi: 10.1089/acm.2014.0033. Epub 2015 Feb 24.
    Results Reference
    result
    Citation
    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 Nursing 2018; 26(1), 31-43. https://doi.org/10.26650/FNJN.387192.
    Results Reference
    result
    Citation
    Kjergaard H, Wijma K, Dykes AK, Alehagen S. Fear of childbirth in obstetrically low-risk nulliparous women in Sweden and Denmark. Journal of Reproductive and Infant Psychology 2008; 26(4): 340-50.
    Results Reference
    result
    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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