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

December 9, 2020 updated by: Gabriele Saccone, Federico II University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Napoli, Italy, 80129
        • Recruiting
        • Gabriele Saccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MUSIC
music in labor
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
No Intervention: control
no music during labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the time of the active phase of labor

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the time of the active phase of labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Gabriele Saccone, MD, Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Anticipated)

February 20, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

December 10, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

unplanned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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