Birthing Ball (Peanut Ball) Positions
Primary Purpose
Labor Pain, Labor Long
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Peanut Ball Position
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring Peanut ball, Birthing ball, labor positions, labor process
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.
Sites / Locations
- Ankara Şehir Hastanesi Kadın Doğum Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Position Group
Control group
Arm Description
Position group
No Position group
Outcomes
Primary Outcome Measures
Labor time
Firsth stage ( active phase and transition phase) time+ and second stage labor time=...minutes
Secondary Outcome Measures
cervical dilation
hourly cervical dilation findings
cervical effacement
hourly cervical effacement findings
fetal head level
hourly fetal head level findings
The pain level
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.
The first breastfeeding process evaluation
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.
maternal satisfaction
"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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04729426
Brief Title
Birthing Ball (Peanut Ball) Positions
Official Title
The Effect of Using a Birthing Ball During Labor on the Labor Process
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gonca Karataş Baran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Labor Long
Keywords
Peanut ball, Birthing ball, labor positions, labor process
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two group. One is interventional group; other is control group.
Masking
Participant
Masking Description
The volunteer who is in the latent phase of labor will not know which group she will be in before joining the study. After accepting to participate in the study, the volunteer will be informed about which group she will be in.
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Position Group
Arm Type
Experimental
Arm Description
Position group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No Position group
Intervention Type
Other
Intervention Name(s)
Peanut Ball Position
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Labor time
Description
Firsth stage ( active phase and transition phase) time+ and second stage labor time=...minutes
Time Frame
max 8 hour
Secondary Outcome Measure Information:
Title
cervical dilation
Description
hourly cervical dilation findings
Time Frame
max 8 hour
Title
cervical effacement
Description
hourly cervical effacement findings
Time Frame
max 8 hour
Title
fetal head level
Description
hourly fetal head level findings
Time Frame
max 8 hour
Title
The pain level
Description
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
max 8 hour
Title
The first breastfeeding process evaluation
Description
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 after labor
Title
maternal satisfaction
Description
"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.
Time Frame
within 30 minutes to two hours after labor
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
primipara pregnant woman
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esma SARIKAYA, professor
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Study Director
Facility Information:
Facility Name
Ankara Şehir Hastanesi Kadın Doğum Hastanesi
City
Ankara
State/Province
Bilkent
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26937158
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.
Results Reference
result
PubMed Identifier
26859467
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.
Results Reference
result
PubMed Identifier
31600716
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.
Results Reference
result
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Birthing Ball (Peanut Ball) Positions
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