NCT04883541

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 9, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

April 17, 2021

Results QC Date

May 18, 2021

Last Update Submit

August 6, 2021

Conditions

Keywords

Labour Preparation ClassLabour SupportMeditationPregnancy Yoga

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups

    the 4th hour on average after the birth

  • Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups

    the 4th hour on average after the birth

Study Arms (2)

The Study Group

EXPERIMENTAL

Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day.

Behavioral: yoga and meditation

Control Group

PLACEBO COMPARATOR

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

Behavioral: Birth preparation training

Interventions

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.

The Study Group

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

Control Group

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (31)

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

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

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

    BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

    RESULT
  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Interventions

YogaMeditation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

The study's being conducted on pregnant women admitted to a training and research hospital on the Anatolian side of Istanbul, high education levels of the pregnant women, and the fact that the participants were determined only in this group were among the limitations of the study. In addition, the results of the study cannot be generalized to the entire population because it was conducted with pregnant women who were healthy and it was their first birth.

Results Point of Contact

Title
Assistant Professor Tuğba YILMAZ ESENCAN
Organization
Üsküdar Üniversitesi

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The present study was conducted as a randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 17, 2021

First Posted

May 12, 2021

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 30, 2018

Last Updated

August 9, 2021

Results First Posted

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
starting 6 months after publication
Access Criteria
JOURNAL EDITOR AND REFEREES TO BE PUBLISHED

Available IPD Datasets

PhD thesis Access