Effect of Music in Labor in Women Who Underwent Induction of Labor

Overview

Women's experience of pain during labor varies greatly, and pain control is a major concern for obstetricians. Several methods have been studied for pain management for women in labor, including drug and non-drug interventions Most methods of non-pharmacological pain management are non-invasive and appear to be safe for mother and baby, including immersion in water, relaxation, acupuncture, and massage. However, their efficacy is unclear, and based mostly on non-randomized studies. On the other hand, there are strong data to support the efficacy of pharmacological methods, including epidural analgesia, which improves pain relief but increase the incidence of operative vaginal delivery Recently a clinical trial showed that music in labor was associated with maternal benefits in women who underwent spontaneous vaginal delivery. However, the effect of music in labor in women undergoing induction of labor is still a subject of debate.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 20, 2021

Interventions

  • Other: music in labor
    • Women in the intervention group will be offered music in labor, defined listening to music from the randomization until the delivery of the baby. Women had the possibility to select the songs at their discretion

Arms, Groups and Cohorts

  • Experimental: MUSIC
    • music in labor
  • No Intervention: control
    • no music during labor

Clinical Trial Outcome Measures

Primary Measures

  • mean pain level during the active phase of labor
    • Time Frame: at the time of the active phase of labor
    • assessed by Visual Analog Scale (VAS) for Pain

Secondary Measures

  • Mean anxiety level during the active phase of labor, second stage, and at post-partum
    • Time Frame: at the time of the active phase of labor
    • assessed by Visual Analog Scale (VAS) for anxiety

Participating in This Clinical Trial

Inclusion Criteria

  • Nulliparous women – Singleton gestation – Vertex presentation – Induction of labor, i.e. cervical ripening with prostaglandins – Gestational age between 37 and 42 weeks Exclusion Criteria:

  • Multiparous womne – Multiple gestations – Preterm labor – Preterm premature rupture of membranes – Induction of labor with oxytocin and without prostaglandins – Induction of labor with balloon – High risk pregnancies, including hypertensive disorders of pregnancies, diabetes, intrauterine growth restriction, fetal abnormalities.

Gender Eligibility: Female

pregnant women

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federico II University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gabriele Saccone, Principal Investigator – Federico II University
  • Overall Official(s)
    • Gabriele Saccone, MD, Principal Investigator, Federico II University
  • Overall Contact(s)
    • Gabriele Saccone, MD, 0817461111, gabriele.saccone@unina.it

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