The Effect of the Multifunctional Birthing Ball on Labor Pain

NCT ID: NCT06229808

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2023-12-29

Brief Summary

Objective: By using the newly designed multifunctional birthing ball, it is aimed to reduce the intense perineal and sacral pain in the first and second stages of labor, to prevent perineal tears, pain and episiotomy opening with perineal heating, to take advantage of the positive effects of the birthing ball on the pelvis to support active labor and shorten the duration of labor, and to increase the satisfaction of mothers with labor by reducing anxiety and pain.

Materials and Methods: The multifunctional birthing ball will support the active movements of the pregnant woman, as well as warming the perineum while providing lumbar and back massage. The multifunctional birthing ball was developed by researchers and manufactured by the Near East University 3D Lab. The bottom of the ball is made of flexible and explosion-proof material filled with air. The purpose of the ball is to enable the pregnant woman to make swinging and bouncing movements during active labor. The massager and heating pad will be controlled by a single electronic circuit. Three different massage modes can be selected: continuous, intermittent and fluctuating. The heating pad can be turned on and off with a single button and the temperature can be adjusted (decrease-increase). To prevent overheating and tissue damage, a maximum temperature of 42 °C was fixed on the control. The inner padding is made of a material that protects both the massager and the heating pad from external factors and also serves as a seat. The shape of the device is designed to ensure that the massager is in full contact with the waist when the pregnant woman sits on the ball. The coating of the massage chair and heating pad is made of cleanable material suitable for hospital use.

Detailed Description

This study was designed to experimentally investigate the effect of a multifunctional birthing ball on perineal pain, sacral pain, total duration of labor, perineal tears, and women's satisfaction with the birth experience during the first and second stages of labor in pregnant women who will deliver vaginally. Pregnant women to be included in the experimental and control groups should meet the following criteria:

• First-time mothers
• At term (37-42 weeks of gestation)
• Single fetal gestation
• Cervical dilatation of 3 cm or greater
• Expected spontaneous delivery
• No pregnancy complications or systemic diseases
• No history of cephalopelvic disproportion, placenta previa, placental abruption, or fetal distress
• Willingness to participate in the study
• Age between 18 and 35 years

Experimental Intervention Participants in the experimental group will receive massages using a multifunctional birthing ball during the first stage of labor. Massages will be administered for 30 minutes each at the end of the latent, active, and transition phases (cervical dilatation 3-4 cm, 5-7 cm, and 8-10 cm, respectively). Visual Analog Scale (VAS) scores will be evaluated three times in each phase to assess low back pain. In the control group, VAS scores will be evaluated three times without massage application for the same periods.

Perineal Heating Application

Perineal heating application will be initiated when the second stage of labor begins and will continue until delivery. The heating application will consist of 20 minutes of application followed by 20 minutes of tissue rest. VAS scores will be evaluated two times during these stages to determine perineal pain. In the control group, VAS scores will be evaluated twice without heating application for the same periods.

Postpartum Evaluation

During the postpartum period, each participant will complete a 30-question "Postpartum Interview Form" that will address questions related to the status of perineal integrity at the end of labor, overall childbirth experience, and satisfaction with the birth process. Additionally, each participant will complete the "Birth Satisfaction Scale" - a 30-item questionnaire designed to assess the woman's satisfaction with her birth experience.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Multifunctional Birthing Ball group

Massages will be applied to the experimental group in the first stage of labor for 30 minutes each at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm), respectively.

Perineal heating application is planned to be performed at least twice until the delivery occurs as 20 minutes of application and 20 minutes of tissue rest periods when the second stage of labor begins (the duration of this stage may reach 2 hours in primiparous women).

Group Type: EXPERIMENTAL

Multifunctional Birthing ball

Intervention Type: DEVICE

In order to reduce low back pain in labor, massages will be applied to the experimental group in the first stage of labor for 30 minutes each at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm), respectively.

Perineal heating application is planned to be performed at least twice until the delivery occurs as 20 minutes of application and 20 minutes of tissue rest periods when the second stage of labor begins (the duration of this stage may reach 2 hours in primiparous women).

Control group

No intervention will be applied

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multifunctional Birthing ball

In order to reduce low back pain in labor, massages will be applied to the experimental group in the first stage of labor for 30 minutes each at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm), respectively.

Perineal heating application is planned to be performed at least twice until the delivery occurs as 20 minutes of application and 20 minutes of tissue rest periods when the second stage of labor begins (the duration of this stage may reach 2 hours in primiparous women).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• First-time mothers
• At term (37-42 weeks of gestation)
• Single fetal gestation
• Cervical dilatation of 3 cm or greater
• Expected spontaneous delivery
• No pregnancy complications or systemic diseases
• Age between 18 and 35 years

Exclusion Criteria

• Non-pregnancy related chronic illness
• Pregnancy-related illness
• Pregnancy complications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Near East University, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Betul Mammadov

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Near East University

Nicosia, , Cyprus

Countries

Cyprus

Other Identifiers

YDU/2021/93-1378

Identifier Type: -

Identifier Source: org_study_id