Birth, First, Labor Pain, Self Efficacy, State Anxiety
Conditions
Keywords
Labour Preparation Class, Labour Support, Meditation, Pregnancy Yoga
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.
Interventions
BEHAVIORALyoga 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.
BEHAVIORALBirth preparation training
The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.
Sponsors
Biruni University
Uskudar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
Intervention model description
The present study was conducted as a randomized controlled study.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of Labor (Pregnant) | 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. |
| Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups | 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. |
| Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups | 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. |
Participant flow
Pre-assignment details
Randomised (n=115) Excluded (n=38): Not meeting inclusion criteria (n=30.) Declined to participate (n=8)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 60 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not attending regular yoga class | 16 | 0 |
| Overall Study | Not attending the pregnancy school | 0 | 9 |
Baseline characteristics
| Characteristic | Total | The Study Group | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 29.9 years STANDARD_DEVIATION 3.5 | 29.7 years STANDARD_DEVIATION 3.44 | 30.2 years STANDARD_DEVIATION 4.09 |
| Body Mass Index (BMI) | 26.357 kg / m2 STANDARD_DEVIATION 3.94 | 25.77 kg / m2 STANDARD_DEVIATION 3.26 | 27.37 kg / m2 STANDARD_DEVIATION 4.62 |
| Sex: Female, Male Female | 90 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 60 |
| other Total, other adverse events | 0 / 30 | 0 / 60 |
| serious Total, serious adverse events | 0 / 30 | 0 / 60 |
Outcome results
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.
Time frame: 16 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| The Study Group | Characteristics of Labor (Pregnant) | Normal birth | 24 participants |
| The Study Group | Characteristics of Labor (Pregnant) | Movement limitation | 5 participants |
| The Study Group | Characteristics of Labor (Pregnant) | Induction | 9 participants |
| The Study Group | Characteristics of Labor (Pregnant) | Enema | 17 participants |
| The Study Group | Characteristics of Labor (Pregnant) | Vaginal Examination | 30 participants |
| The Study Group | Characteristics of Labor (Pregnant) | Caesarian | 6 participants |
| The Study Group | Characteristics of Labor (Pregnant) | Electronic Fetal Monitoring | 30 participants |
| Control Group | Characteristics of Labor (Pregnant) | Caesarian | 21 participants |
| Control Group | Characteristics of Labor (Pregnant) | Enema | 49 participants |
| Control Group | Characteristics of Labor (Pregnant) | Induction | 50 participants |
| Control Group | Characteristics of Labor (Pregnant) | Electronic Fetal Monitoring | 59 participants |
| Control Group | Characteristics of Labor (Pregnant) | Vaginal Examination | 59 participants |
| Control Group | Characteristics of Labor (Pregnant) | Movement limitation | 28 participants |
| Control Group | Characteristics of Labor (Pregnant) | Normal birth | 39 participants |
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.
Time frame: the 4th hour on average after the birth
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Study Group | 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 |
| The Study Group | 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 |
| The Study Group | 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 |
| Control Group | 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.) | 9.86 units on a scale | Standard Deviation 0.41 |
| Control Group | 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) | 5.48 units on a scale | Standard Deviation 1.51 |
| Control Group | 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.) | 8.80 units on a scale | Standard Deviation 0.98 |
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.
Time frame: the 4th hour on average after the birth
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Study Group | 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 |
| The Study Group | 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 |
| The Study Group | 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 14.1 |
| The Study Group | 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 |
| The Study Group | 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 |
| Control Group | Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups | Self-sufficiency II | 234.50 score on a scale | Standard Deviation 32 |
| Control Group | Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups | Result expectation I | 124.32 score on a scale | Standard Deviation 27.2 |
| Control Group | Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups | Self-sufficiency I | 205.80 score on a scale | Standard Deviation 40.94 |
| Control Group | Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups | Result expectation II | 125.30 score on a scale | Standard Deviation 19.66 |
| Control Group | Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups | Sufficiency expectation II | 109.20 score on a scale | Standard Deviation 16.91 |
p-value: <0.05t-test, 2 sided
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.
Time frame: the 4th hour on average after the birth
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Study Group | 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 |
| The Study Group | 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 |
| Control Group | Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups | WIJMAA | 57.75 score on a scale | Standard Deviation 33.27 |
| Control Group | Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups | WIJMAB | 72.38 score on a scale | Standard Deviation 27.32 |