Clinical trial NCT05711472: The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction
Official title: The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth Problems
Labor Pain
Birth Disorder
Keywords: Birth pain
labor duration
birth comfort
birth satisfaction
birth ball
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction. The sample of the study consisted of 120 primiparous pregnant women presented to the delivery room between November 2021 and April 2022. Pregnant women were randomly assigned to the Intervention Group (IG, n=60) or the Control Group (KG, n=60). After the cervical dilatation reached at 4 cm, the pregnant women in the IG performed birth ball exercises, adhering to the birth ball guide created by the researcher. No intervention was made in the control group other than standard midwifery care practices.

A Personal Information Form,a Visual Analog Scale (VAS), the Childbirth Comfort Questionnaire (CCQ), a Labor and Postpartum Follow-up Form, and the Mackey Childbirth Satisfaction Rating Scale (MCSRS) were used for data collection. Women in both groups underwent VAS when cervical dilatation was 4 cm and 9 cm, and the CCQ was applied when dilatation was 8 cm. The MCSRS was administered two hours after delivery.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion criteria:

* 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.

Exclusion criteria in the research process:

* 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.

Primary outcomes:
measure: Personal information form before intervention
timeFrame: First 24 hours
measure: Evaluation of birth
timeFrame: First 24 hours
measure: Evaluation of labor pain
timeFrame: First 24 hours
measure: Evaluation of Childbirth Comfort Questionnaire
timeFrame: First 24 hours
measure: Birth results information
timeFrame: Postpartum 1sth hours (after birth first 1 hour)
measure: Evaluation of Childbirth Satisfaction
timeFrame: Postpartum 1sth hours (after birth first 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: seyhan çankaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: