The Effect of the Multifunctional Birthing Ball on Labor Pain

NCT06229808 | Completed

• 1 other identifier: YDU/2021/93-1378
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Labor Pain; Birth Ball; Active Delivery; Massage; Perineal Warming

Outcome Measures

Primary Outcomes (3)

• Evaluating pain scores by performing lumbar massage with the massage chair on the birthing ball in order to reduce the back pain experienced during birth.

  In order to reduce the back pain experienced during birth, the experimental group received massages in the first stage of birth, respectively; It will be applied for 30 minutes at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm). To determine low back pain at birth, VAS (visual analogue scale) scores will be evaluated a total of three times at all these stages. In the control group, VAS scores will be evaluated three times without massage application for the same period of time.

  during the intervention

• Evaluating perineal pain with perineal heating application

  Perineal heating application is planned to be performed at least twice when the second phase of labor begins (in primiparas, this phase may last up to 2 hours), with a 20-minute application and a 20-minute tissue rest period until birth. To determine perineal pain, VAS (visual analogue scale) scores will be evaluated twice in all these stages. In the control group, VAS scores will be evaluated twice at the same time without heating.

  during the intervention

• Applying the "Birth Satisfaction Scale" to measure the woman's satisfaction with her birth experience in the postpartum period.

  Finally, in the postpartum period, the "Birth Satisfaction Scale" consisting of 30 items will be filled in to measure the woman's satisfaction with her birth experience. The original "Birth Satisfaction Scale (BSS)" was developed by Caroline Hollins in 2009. A Turkish validity and reliability study was conducted by Cosar Cetin F. and his colleagues in 2015. Responses to this scale, which is a 5-point Likert type; Absolutely I agree. 5; I agree. 4; I'm undecided 3; Disagree 2; Strongly Disagree: scores as 1. In the scale items; Items 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25, and 29 are scored as reversed items. The total number of points to be obtained from the scale varies between 30 and 150 points. Subthemes in the scale were determined as quality of care, birth environment, adequate support and relationships with health professionals. High scores from the scale indicate that the woman is more satisfied with birth.

  immediately after the intervention

Study Arms (2)

Multifunctional Birthing Ball group

EXPERIMENTAL

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).

Device: Multifunctional Birthing ball

Control group

NO INTERVENTION

No intervention will be applied

Interventions

Multifunctional Birthing ball 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).

Multifunctional Birthing Ball group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Birth pain is a pain experienced only by women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 29, 2024
• Study Start: January 2, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CY (1)