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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04883541
Other study ID # Uskudar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date January 30, 2018

Study information

Verified date August 2021
Source Uskudar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date January 30, 2018
Est. primary completion date January 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
yoga and meditation
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.
Birth preparation training
The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Uskudar University Biruni University

References & Publications (31)

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 — View Citation

Çiçek Ö, Okumus H. Dogumda 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.

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. — View Citation

Dick-Read G. Childbirth Without Fear: The Principles and Practice of Natural Childbirth. Second edition. UK: Pinter & Martin Ltd; 2013. 56-100.

Erkaya R, Karabulutlu Ö, Çalika YK. Defining childbirth fear and anxiety levels in pregnant women procedia. Social and Behavioral Sciences 2017; 237:1045-1052.

Esencan TY, Karabulut Ö, Yildirim AD, Abbasoglu DE, Külek H. et. al. Type of delivery, time of initial breastfeeding, and skin-to-skin contact of pregnant women participating in childbirth preparation education. Florence Nightingale Journal of Nursing 201

Gönenç IM, Çakirer-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.

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.

Ip WY, Chan D, Chien WT. Chinese version of the Childbirth Self-efficacy Inventory. J Adv Nurs. 2005 Sep;51(6):625-33. — View 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. Review. — View Citation

Karakus A, Sahin 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.

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.

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. — View 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.1365-2850.2011.0 — View 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.

Lowe NK. Maternal confidence for labor: development of the Childbirth Self-Efficacy Inventory. Res Nurs Health. 1993 Apr;16(2):141-9. — View 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.

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. — View Citation

Öner N, LeCompte A. State Trait Anxiety Inventory Handbook, Istanbul; Bogaziçi University Publications;1983.

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. — View Citation

Rathfisch G. Natural Philosophy of Birth. Istanbul: Nobel Medical Bookstores; 2012.

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. — View 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.

Serçekus 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. — View Citation

Sharma M, Branscum P. Yoga interventions in pregnancy: a qualitative review. The Journal of Alternative and Complementary Medicine 2015; 1-9. DOI: 10.1089/acm.2014.0033.

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. Review. — View 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. — View 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. — View Citation

Sydsjö G, Blomberg M, Palmquist S, Angerbjörn 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. — View 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. Review. — View 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. — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 16 hours
Primary 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. the 4th hour on average after the birth
Secondary 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. the 4th hour on average after the birth
Secondary 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. the 4th hour on average after the birth
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