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

Not Applicable

• Conditions: Labor Pain
• Interventions: Other: music in labor

• Registration Number: NCT04662424
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-03
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-09
• Last Update Submitted: 2020-12-09
• Study First Posted: 2020-12-10
• Last Update Posted: 2020-12-10
• Primary Completion: 2021-02-20
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MUSIC	music in labor	music in labor

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Napoli, Italy