Trial Outcomes & Findings for Effects of Yoga and Meditation on The Birth Process (NCT NCT04883541)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

16 hours

Results posted on

2021-08-09

Participant Flow

Randomised (n=115) Excluded (n=38): Not meeting inclusion criteria (n=30.) Declined to participate (n=8)

Participant milestones

Participant milestones
Measure	The Study Group Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. 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.	Control Group The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. 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.
Overall Study STARTED	46	69
Overall Study COMPLETED	30	60
Overall Study NOT COMPLETED	16	9

Reasons for withdrawal

Reasons for withdrawal
Measure	The Study Group Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. 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.	Control Group The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. 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.
Overall Study Not attending regular yoga class	16	0
Overall Study Not attending the pregnancy school	0	9

Baseline Characteristics

Effects of Yoga and Meditation on The Birth Process

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Study Group n=30 Participants Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. 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.	Control Group n=60 Participants The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. 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.	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	60 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.7 years STANDARD_DEVIATION 3.44 • n=5 Participants	30.2 years STANDARD_DEVIATION 4.09 • n=7 Participants	29.9 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	60 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	25.77 kg / m2 STANDARD_DEVIATION 3.26 • n=5 Participants	27.37 kg / m2 STANDARD_DEVIATION 4.62 • n=7 Participants	26.357 kg / m2 STANDARD_DEVIATION 3.94 • n=5 Participants

PRIMARY outcome

Timeframe: 16 hours

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.

Outcome measures

Outcome measures
Measure	The Study Group n=30 Participants Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. 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.	Control Group n=60 Participants The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. 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.
Characteristics of Labor (Pregnant) Caesarian	6 participants	21 participants
Characteristics of Labor (Pregnant) Electronic Fetal Monitoring	30 participants	59 participants
Characteristics of Labor (Pregnant) Vaginal Examination	30 participants	59 participants
Characteristics of Labor (Pregnant) Movement limitation	5 participants	28 participants
Characteristics of Labor (Pregnant) Enema	17 participants	49 participants
Characteristics of Labor (Pregnant) Induction	9 participants	50 participants
Characteristics of Labor (Pregnant) Normal birth	24 participants	39 participants

PRIMARY outcome

Timeframe: the 4th hour on average after the birth

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.

Outcome measures

Outcome measures
Measure	The Study Group n=30 Participants Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. 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.	Control Group n=60 Participants The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. 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.
Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group VAS LATENT (This is when pregnant woman cervix becomes soft and thin)	3.00 units on a scale Standard Deviation 1.84	5.48 units on a scale Standard Deviation 1.51
Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group VAS ACTIVE (During active labor, cervix will dilate from 4 centimeters (cm) to 7 cm.)	6.90 units on a scale Standard Deviation 1.88	8.80 units on a scale Standard Deviation 0.98
Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group VAS TRANSITION (cervix will dilate from 7 to its final 10 centimeters.)	8.24 units on a scale Standard Deviation 2.12	9.86 units on a scale Standard Deviation 0.41

SECONDARY outcome

Timeframe: the 4th hour on average after the birth

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.

Outcome measures

Outcome measures
Measure	The Study Group n=30 Participants Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. 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.	Control Group n=60 Participants The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. 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.
Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups WIJMAA	47.67 score on a scale Standard Deviation 26.37	57.75 score on a scale Standard Deviation 33.27
Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups WIJMAB	29.70 score on a scale Standard Deviation 17.51	72.38 score on a scale Standard Deviation 27.32

SECONDARY outcome

Timeframe: the 4th hour on average after the birth

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.

Outcome measures

Outcome measures
Measure	The Study Group n=30 Participants Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. 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.	Control Group n=60 Participants The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. 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.
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups Result expectation I	137.23 score on a scale Standard Deviation 20.21	124.32 score on a scale Standard Deviation 27.20
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups Self-sufficiency I	223.03 score on a scale Standard Deviation 36.83	205.80 score on a scale Standard Deviation 40.94
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups Result expectation II	148.30 score on a scale Standard Deviation 14.10	125.30 score on a scale Standard Deviation 19.66
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups Sufficiency expectation II	139.87 score on a scale Standard Deviation 16.88	109.20 score on a scale Standard Deviation 16.91
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups Self-sufficiency II	288.17 score on a scale Standard Deviation 28.25	234.50 score on a scale Standard Deviation 32.00

Adverse Events

The Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Professor Tuğba YILMAZ ESENCAN

Üsküdar Üniversitesi

Phone: +905057084946

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place