Clinical trial NCT04729426: Birthing Ball (Peanut Ball) Positions
Official title: The Effect of Using a Birthing Ball During Labor on the Labor Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Labor Long
Keywords: Peanut ball
Birthing ball
labor positions
labor process
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two group. One is interventional group; other is control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primiparous at 37-42 weeks of gestation,
* between the ages of 18-40,
* Not diagnosed with risky pregnancy (Intrauterine Growth Retardation, Fetal Anomaly, Polyhydramnios or Oligohydraamnios, Thromboembolic Diseases, Presentation Anomalies, Premature Membrane Rupture, Multiple Pregnancy, Sexually Transmitted Disease, Preeclampsia / Eclampsia etc.)
* Without systemic disease (Hypertension, Heart Disease, Diabetes, Asthma, Thyroid, Epilepsy, etc.)
* Single pregnancy,
* Vaginal delivery planned with cephalic admission,
* in the latent phase of labor,
* Epidural anesthesia / analgesia was not applied,
* Volunteering to participate in research,
* Pregnant women who do not have any communication disorder will be taken.

Exclusion Criteria:

* Failure to meet the inclusion criteria is the exclusion criteria.

Exclusion (Withdrawal) from the Study Criteria

* Having adaptation problems in applying the positions to be given,
* Maternal (vital signs deviation from normal, hyperstimulation, abnormal bleeding, etc.) and fetal complications (such as fetal distress, cord entanglement, cord prolapse) during delivery,
* Caesarean section, which could not complete the normal birth process,
* Pregnant women who give up working at any stage of the study will be excluded from the study.

Primary outcomes:
measure: Labor time
timeFrame: max 8 hour
Secondary outcomes:
measure: cervical dilation
timeFrame: max 8 hour
measure: cervical effacement
timeFrame: max 8 hour
measure: fetal head level
timeFrame: max 8 hour
measure: The pain level
timeFrame: max 8 hour
measure: The first breastfeeding process evaluation
timeFrame: within 30 minutes after labor
measure: maternal satisfaction
timeFrame: within 30 minutes to two hours after labor
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Şehir Hastanesi Kadın Doğum Hastanesi
state: Bilkent
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Esma SARIKAYA, professor
role: STUDY_DIRECTOR
References:
citation: Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing Length of Labor and Cesarean Surgery Rate Using a Peanut Ball for Women Laboring With an Epidural. J Perinat Educ. 2015;24(1):16-24. doi: 10.1891/1058-1243.24.1.16.
citation: Roth C, Dent SA, Parfitt SE, Hering SL, Bay RC. Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):140-6. doi: 10.1097/NMC.0000000000000232.
citation: Grenvik JM, Rosenthal E, Saccone G, Della Corte L, Quist-Nelson J, Gerkin RD, Gimovsky AC, Kwan M, Mercier R, Berghella V. Peanut ball for decreasing length of labor: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:159-165. doi: 10.1016/j.ejogrb.2019.09.018. Epub 2019 Sep 20.