- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04827797
Effects of Different Birthing Balls Used at the First Stage of Childbirth
Effects of Different Birthing Balls Used at the First Stage of Childbirth on Birth Outcomes and Maternal Satisfaction November, 2018
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.
IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some non-pharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.
What the results of this study add? There is no studies using the peanut ball and the spherical birth ball together. In our study, it was found that both balls are effective, but the spherical birth ball is more significant.
What the implications are of these findings for clinical practice and/or further research? Our study suggested that the spherical birth ball had effective on birth outcomes. Future studies should be performed to investigate the effects of birth balls in the postpartum period, breastfeeding or prenatal period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mersin
-
Toroslar, Mersin, Turkey
- Tuğçe Sönmez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primiparous
- admitted to the delivery room for vaginal delivery
- 38-40 week
- being in the latent phase of labor
- having no obstetric risks
Exclusion Criteria:
- undergo caesarean sections for various reasons
- having obstetric risks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: birth ball
The positions and movements for birth ball in the active and latent phases: kneeling on the ground and leaning on the spherical birthing ball, sitting on the ball with front support, sitting positions on the spherical birthing ball, full rotation of hip, moving to the right/left, back and forth.
Positions and movements were repeated every 30 minutes.
The 30-minute intervals were interrupted in cases where the women were not feeling well.
|
Birth balls to exercise
Other Names:
|
|
Experimental: peanut ball
The positions and movements for the pregnant women in peanut ball: upright sitting position, forward bending positions, with backward and forward movement and swaying right and left on the peanut ball
|
Birth balls to exercise
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Introductory Information Form
Time Frame: when pregnant women come to the delivery room
|
this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.
|
when pregnant women come to the delivery room
|
|
Visual Analogue Scale
Time Frame: Latent, active and transition phase in labor
|
in this scale, the participants marked the severity of their pain on a 10-cm ruler with one end stating "no pain" and the other end "worst possible pain".
VAS was used to determine the severity of pain and the effectiveness of the intervention in this study.
|
Latent, active and transition phase in labor
|
|
Verbal Rating Scale
Time Frame: Latent, active and transition phase of labor
|
This scale is based on participants' choice of word that defines their pain state
|
Latent, active and transition phase of labor
|
|
Partogram
Time Frame: active phase of labor
|
This is used starting from the active phase of labor.
The progress of the labor and the health status of the baby are monitored on the partogram
|
active phase of labor
|
|
Evaluation Scale for Maternal Satisfaction with Normal Delivery
Time Frame: within a period of 1-4 hours postpartum
|
This is used to assess maternal satisfaction in normal delivery.
Higher total scores on the scale indicate stronger maternal satisfaction with the hospital care provided in normal delivery
|
within a period of 1-4 hours postpartum
|
Collaborators and Investigators
Investigators
- Principal Investigator: tuğçe sönmez, Gaziantep ıslamic science and tecnology university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3301cukurova
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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