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NCT06229808

The Effect of the Multifunctional Birthing Ball on Labor Pain

Completed NA Last updated 29 January 2024
What this trial tests

NA trial testing Multifunctional Birthing ball in Labor Pain in 40 participants. Completed in 29 December 2023.

Timeline
2 January 2022
Primary endpoint
29 December 2023
29 December 2023

Quick facts

Lead sponsorNear East University, Turkey
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment40
Start date2 January 2022
Primary completion29 December 2023
Estimated completion29 December 2023
Sites1 location across Cyprus

Drugs / interventions tested

Conditions studied

Sponsor

Near East University, Turkey

Who can join

Adults 18 to 35, female only, with Labor Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Labor Pain

Currently open trials in the same condition.

Other Near East University, Turkey trials

Trials by the same sponsor.

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Data sources for this page

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