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

NCT04827797 | Completed

• 1 other identifier: 3301cukurova
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain; Satisfaction, Patient; Labor Fast

Keywords

birth ball; labor pain; satisfaction; maternal; fetal

Outcome Measures

Primary Outcomes (5)

• Introductory Information Form

  this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.

  when pregnant women come to the delivery room

• Visual Analogue Scale

  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

  This scale is based on participants' choice of word that defines their pain state

  Latent, active and transition phase of labor

• Partogram

  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

  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

Study Arms (2)

birth ball

EXPERIMENTAL

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.

Device: balls

peanut ball

EXPERIMENTAL

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

Device: balls

Interventions

balls DEVICE

Birth balls to exercise

Also known as: Birth ball, Peanut Ball

birth ball; peanut ball

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• primiparous
• admitted to the delivery room for vaginal delivery
• week
• being in the latent phase of labor
• having no obstetric risks

You may not qualify if:

• undergo caesarean sections for various reasons
• having obstetric risks

Sponsors & Collaborators

• Gaziantep Islam Science and Technology University: lead

Study Sites (1)

Tuğçe Sönmez

Toroslar, Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Patient Satisfaction; Personal Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• tuğçe sönmez

  Gaziantep ıslamic science and tecnology university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: November 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 20, 2019
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

TU (1)