NCT05711472

Brief Summary

It has been reported that the birth ball has benefits such as decreasing the perception of labor pain, reducing the anxiety level, shortening the duration of the first stage of labor, increasing the satisfaction of birth, and facilitating the descent of the fetal head, but the literature is quite limited. So, this randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

January 9, 2023

Last Update Submit

February 2, 2023

Conditions

Keywords

Birth painlabor durationbirth comfortbirth satisfactionbirth ball

Outcome Measures

Primary Outcomes (6)

  • Personal information form before intervention

    Assessed using personal information. This instrument includes questions about women's sociodemographic, obstetric and childbirth readiness characteristics.

    First 24 hours

  • Evaluation of birth

    Birth Follow-up Form was used to evaluate labor. This Birth Follow-up form is evaluating; partograph, effacement-dilatation at first admission to the hospital, presence of amniotic sac at first admission, presence of episiotomy, time from active phase of labor until dilation is complete, time until the baby's head comes out after full dilation.

    First 24 hours

  • Evaluation of labor pain

    Pain of pregnant women during labor was evaluated with Visual Analogue Scale (VAS). VAS scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.

    First 24 hours

  • Evaluation of Childbirth Comfort Questionnaire

    Childbirth Comfort Questionnaire (CCQ) scales were applied to measure their comfort at the time of birth. The scale determines the comfort levels of women during childbirth. The real name of the scale is "Childbirth Comfort Questionnaire". The original scale consists of 14 items and is in a five-point Likert type. Each item is scored between 1-5.

    First 24 hours

  • Birth results information

    Birth results information form evaluates; APGAR score at the 1st, 5th, and 10th minutes of the newborn; baby's gender.

    Postpartum 1sth hours (after birth first 1 hour)

  • Evaluation of Childbirth Satisfaction

    Mackey Childbirth Satisfaction Rating Scale (MCSRS) evaluation to determine birth satisfaction form has been applied. The scale assesses women's satisfaction with the birth process. The scale consists of six 34-item subscales (nine items about self-satisfaction, two items about spouse's satisfaction, three items about baby's satisfaction, nine items about midwife-nurse satisfaction, eight items about doctor's satisfaction, three items about labor pain and labor. satisfaction). The scale is 5-point Likert type and is scored between 1 and 5. The lowest score in the scale is 32 and the highest score is 169, and as the total score increases, birth satisfaction also increases.

    Postpartum 1sth hours (after birth first 1 hour)

Study Arms (2)

Experimental

EXPERIMENTAL

Intervention Group Three different ball sizes, 55, 65 and 75 cm in diameter, were provided to the pregnant women, and the appropriate ball size was determined according to the height of the participant. In order for the pregnant woman to continue the balance exercises, they were allowed to sit on the round birth ball with their knees and hips at an angle of approximately 90°, with an upright spine. A birth ball of 55 cm was used for women between 150 and 160 cm in height, 65 cm for women between 160 and 170 cm, and 75 cm for women between 170 and 185 cm in height. Exercises with the round birth ball were guided by the researcher and the pregnant women performed the exercises in line with the guide. These are the movements performed with the round birth ball in 3 different positions: sitting (pelvic rocking movement, forward-backward and right-to-left rocking, forward supported sitting, and springing motion), kneeling, and squatting (ball hugging and pelvic rocking motion).

Other: birth ball exercise

No Intervention

NO INTERVENTION

Control Group The followings were administered to the pregnant women in the Control Group after they were admitted to the hospital for delivery: * Information was given about the research, * Written consent was obtained, * Routine practices and care were provided in the delivery room (taking anamnesis, taking vital signs, demonstrating correct breathing techniques, ensuring freedom of movement) * Cervical changes were recorded on the partograph by vaginal examination, * EFM (Electronic Fetal Monitoring) was applied based on doctor's orders, * Fetal Heart Sound (FHS) was listened to every half hour and recorded on the partograph.

Interventions

birth ball exercise used in childbirth

Experimental

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being 18 years or older;
  • being in 37-42 weeks of pregnancy;
  • having a singleton pregnancy;
  • having a cervical dilatation of 1-4 cm;
  • being primiparous;
  • not having any complications that prevent vaginal delivery;
  • not having any extremity problems for using the birth ball and performing activities;
  • being able to speak and understand Turkish.

You may not qualify if:

  • Having maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature rupture of membranes, presentation anomalies, intrauterine growth retardation, fetal anomaly, intrauterine death, fetal macrosomia, fetal distress, etc.),
  • getting pregnant by assisted reproductive techniques,
  • electing cesarean section.
  • To receive induction (oxytocin, prostaglandins, and misoprostol);
  • having a cesarean delivery due to any complications;
  • the baby admitted to the neonatal intensive care unit for any reason;
  • receiving analgesics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor PainCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • seyhan çankaya, PhD

    Selcuk 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 Seyhan Çankaya

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 3, 2023

Study Start

November 1, 2021

Primary Completion

April 1, 2022

Study Completion

September 23, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations