Ankara Şehir Hastanesi Kadın Doğum Hastanesi
Ankara, Bilkent, Turkey (Türkiye)
NCT Number: NCT04729426
In this study, it was aimed to position by using peanut ball, which is a kind of birth ball, in the first stage of delivery in pregnant women who are planned to have vaginal delivery with cephalic admission, who is a primipara, who do not have a risky pregnancy and systemic disease; It will be done to determine the effect on the birth process.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Ankara, Bilkent, Turkey (Türkiye)
The group of healthy pregnant women who meet the inclusion criteria will be determined by randomization according to the order of application to the delivery room in the latent phase. Positions will be changed every 30 minutes using the peanut ball tool in a group (intervention group) in active phase and transition phase. These positions are; side-lying position, compressed side-lying position, semi-sitting position, forward leaning position, upright sitting position and pushing position. All positions will be given to the pregnant woman by the researcher and she will be with the pregnant woman during the position intervention. How to give the peanut ball positions is indicated in the flow chart with photographs. Position application will not be applied to the other group (control group), routine procedure of the hospital will be applied.
Parameters to Look for:
The researcher will evaluate the progress of the birth process (cervical dilatation and effacement, fetal head descent, Fetal Hearth Rate, duration of the first and second stages of labor), delivery method and information about the baby (gender, weight, height and head circumference length, APGAR) in both groups of women from the hospital's partograph records. Information on the progress of the birth process from the active phase of each pregnant birth to the completion of the birth process in the hospital is processed in the partograph with 30 minutes intervals.
The pain level in each stage and phases of labor will be evaluated by the researcher with a visual pain scale.
The first breastfeeding process will be observed and evaluated by the researcher using the "LATCH Breastfeeding Diagnostic and Evaluation Scale" in the delivery room.
Finally, when the mother relaxes physically and goes to bed, the researcher will apply the "Birth Satisfaction Scale" to assess maternal satisfaction with care at birth.
Study Group Population: The population of the study will be composed of primiparous pregnant women who applied to Ankara City Hospital Obstetrics and Gynecology Clinic Delivery Room.
Sample of the Study Group: Since there is no reference study (duration of delivery) for the main research question created to examine the difference in the intervention and control groups, the required sample size calculation will be made in groups of twenty (case: 20, control: 20) and the effect width will be calculated and Type I error 0.05 and it will be made with 95% power.
Since the minimum number of samples required is taken into account with loss, 20% will be added. The G power program will be used to calculate the number of samples required for the study.
The randomization of the groups for pre-application was done with the computer randomization program Random Allocation Software. Pre-application data will be included in the research data. The number of pregnant women in the pre-application will be subtracted from the number of pregnant women required according to the number of samples determined after the pre-application, and re-randomization for the remaining number of pregnant women will be made with this program.
Data Evaluation: The compatibility of the continuous variables to be obtained within the scope of the study to normal distribution will be examined with the Shapiro-Wilk test. Mean ± standard deviation will be used in the representation of descriptive statistics related to the variables that conform to the normal distribution, while the median (Interquartile Width - DIAG; minimum; maximum) will be used for distorted data, and the number and percentage will be used in the representation of categorical variables. In comparison of the variables measured in the groups, the necessary assumptions will be examined and appropriate t-test or Man-Whitney u test methods will be used. Comparison of groups and categorical variables will be made with the appropriate chi-square tests. All hypotheses will be established bilaterally and the statistical significance level will be accepted as p <0.05. IBM SPSS Statistics 23.0 program will be used for statistical analysis and calculations.
Data Collection Tools:
Data will be collected with the data collection form (Case Report Form). The data collection form consists of five parts.1. General Information;2. Observations and Findings;3. Visual Pain Scale;4. Birth Satisfaction Scale:5. LATCH Breastfeeding Diagnostic and Evaluation Scale.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion (Withdrawal) from the Study Criteria
The group of healthy pregnant women who meet the inclusion criteria will be determined by randomization according to the order of application to the delivery room. A group (intervention group) will be given positions using the peanut ball tool in active phase and transition phase and the positions will be changed every 30 minutes.
Time frame: max 8 hour
Firsth stage ( active phase and transition phase) time+ and second stage labor time=...minutes
Time frame: max 8 hour
hourly cervical dilation findings
Time frame: max 8 hour
hourly cervical effacement findings
Time frame: max 8 hour
hourly fetal head level findings
Time frame: max 8 hour
The pain level in each stage and phases of labor will be evaluated by the researcher with visual pain scale.The pregnant woman marks her own pain on a 10 cm horizontal ruler with painlessness on one end of the scale and the most severe pain on the other . In the study conducted, the visual comparison scale of ten units will be evaluated as the level of pain experienced at birth: 0 = None, 10 = Intractable pain. Pain scale level categorization; It will be categorized in four sections as 0 points: no pain, 1-4 points: mild pain, 5-6 points: moderate pain, 7-10 points: severe pain.
Time frame: within 30 minutes after labor
The first breastfeeding process will be observed and evaluated by the researcher using the "LATCH Breastfeeding Diagnostic and Evaluation Scale" in the delivery room.The name of the diagnostic tool LATCH is derived from the English initials of these five criteria: L, Latch on the brest; A, seeing / hearing the baby's swallowing movement (Audible swallowing); T is the type of the nipple; C is the mother's comfort regarding the nipple and nipple (Comfort breast / nipple) and H is the holding position for the baby (Hold / Help). Each item is scored between 0-2 points. The total score that can be obtained from the tool is 0-10, and the high score means higher breastfeeding success.
Time frame: within 30 minutes to two hours after labor
"Birth Satisfaction Scale" will be applied to evaluate maternal satisfaction with care at birth.Birth Satisfaction Scale is a measurement tool that consists of 10 items and has 3 sub-dimensions, applied to women who give normal birth in the first ten days postpartum.The scale is 5-point Likert type. Strongly disagree, "0 point", disagree "1 point", indecisive "2 points", agree "3 points", strongly agree "4 points". The scale is between 0 and 40 points. 6 items are positive, 4 items are negative, and 4 items are scored in reverse. The reverse scored items are 2., 4., 7, and 8. The higher the score obtained from the scale, the higher the birth satisfaction of the woman.
Gonca Karataş Baran
Other
The Effect of Using a Birthing Ball During Labor on the Labor Process
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