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Completed

NCT Number: NCT04827797

Effects of Different Birthing Balls Used at the First Stage of Childbirth

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.

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Key information

Conditions

Labor Pain Behavior Health Behavior Labor Fast Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Personal Satisfaction Satisfaction, Patient Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tuğçe Sönmez

Toroslar, Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balls

Device

Birth balls to exercise

Other names: Birth ball, Peanut Ball

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Gaziantep Islam Science and Technology University

Other

Registry information

Official study title

Effects of Different Birthing Balls Used at the First Stage of Childbirth on Birth Outcomes and Maternal Satisfaction November, 2018

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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