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NCT06229808
The Effect of the Multifunctional Birthing Ball on Labor Pain
NA trial testing Multifunctional Birthing ball in Labor Pain in 40 participants. Completed in 29 December 2023.
29 December 2023
Quick facts
| Lead sponsor | Near East University, Turkey |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 40 |
| Start date | 2 January 2022 |
| Primary completion | 29 December 2023 |
| Estimated completion | 29 December 2023 |
| Sites | 1 location across Cyprus |
Drugs / interventions tested
- Multifunctional Birthing ball
Conditions studied
- Labor Pain — all drugs for Labor Pain →
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.
Verify or expand the search:
- PubMed search for NCT06229808
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Labor Pain
Currently open trials in the same condition.
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- NCT07401147 — Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor. · NA · recruiting
- NCT07395934 — Comparing PIEB and CEI for Labor Pain Relief · NA · recruiting
- NCT06819579 — Exploring the Optimal Concentration of Lidocaine Test Dose for Labor Analgesia · NA · active not recruiting
Other Near East University, Turkey trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06229808 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Near East University, Turkey
- Last refreshed: 29 January 2024
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