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

NCT04662424 | Unknown

• 1 other identifier: 301/20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• mean pain level during the active phase of labor

  assessed by Visual Analog Scale (VAS) for Pain

  at the time of the active phase of labor

Secondary Outcomes (1)

• Mean anxiety level during the active phase of labor, second stage, and at post-partum

  at the time of the active phase of labor

Study Arms (2)

MUSIC

EXPERIMENTAL

music in labor

Other: music in labor

control

NO INTERVENTION

no music during labor

Interventions

music in labor OTHER

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

MUSIC

Eligibility Criteria

• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Napoli, 80129, Italy

RECRUITING

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Gabriele Saccone, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Saccone, MD

CONTACT

0817461111; gabriele.saccone@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: December 3, 2020
• Primary Completion: February 20, 2021
• Study Completion: March 1, 2021
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

IT (1)