The Effect of the Multifunctional Birthing Ball on Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

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.
    

Intervention name(s): Multifunctional Birthing ball
Intervention type(s): Device
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Labor Pain; Birth Ball; Active Delivery; Massage; Perineal Warming