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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662424
• Other study ID #: 301/20
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: December 2020
• Source: Federico II University
• Contact: Gabriele Saccone, MD
• Phone: 0817461111
• Email: gabriele.saccone[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean anxiety level during the active phase of labor, second stage, and at post-partum	assessed by Visual Analog Scale (VAS) for anxiety	at the time of the active phase of labor