Trial of Music During Labor and Delivery

October 7, 2020 updated by: Gabriele Saccone, Federico II University

Music During Labor and Delivery: Randomized Controlled Trial

The use of music is widely supported in various areas of medicine: first of all in the psychiatric field as in the treatment of autism in children, obtaining surprising results even on Alzheimer's patients, or the unparalleled effect of music on those suffering from depression. To strengthen the thesis of the usefulness of music in medicine there is what is called PNEI, or the psychoneuroendocrinoimmunology. This discipline consists in the study of mutual interactions between mental activity, behavior, nervous system, endocrine system and immune reactivity. The PNEI itself no longer pays attention to the mind with respect to the body, but using the principles of the empirical epistemology of the scientific method strives to clarify those connections that make the nervous system, mind, immunity and hormonal regulation a unique and complex homeostatic control system of the individual, whose synergism would be able to modify certain biological behaviors, such as the transition from a distress to an eustress. This passage would seem to be of particular obstetric interest going to significantly change the course of labor in terms of pain, anxiety and well-being of women. In fact, many women prefer not to resort to partoanalgesia and famaci for pain control during labor.

A recent Cochrane Review analyzed the effectiveness of music in the control of pain in labor, confirming its role in this sense. However, he concluded that the quality of available evidence varied from low to very low, thus highlighting the need for further studies in this area.

Thus, the present study arises with the rational to satisfy this need for further investigation into the positive effects of music on pain in women in labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Italy
      • Napoli, Italy, 80129
        • 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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton gestations;
  • term of phisiological pregnancy
  • spontaneous labor
  • diagnosis of active phase of labor;
  • nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
  • maternal age between 18 and 45 years.

Exclusion Criteria:

  • multiple gestations;
  • preterm labor;
  • preterm premature rupture of membranes
  • induction to delivery labor;
  • Hipertensive disorders;
  • fetal abnormalities;
  • diabetes mellitus;
  • intrauterine growth retardation;
  • post-term pregnancy;
  • multiple vaginal delivery;
  • women with an altered state of consciousness, severely ill, mentally disabled;
  • women who are unconscious, severly ill, mentally handicapped;
  • women under the age of 18 years or over the age of 45 years.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music during labor and delivery
Other: music
music during labor and delivery
No Intervention: No music during labor and delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during the active phase
Time Frame: during the labor
pain assessed with VAS
during the labor

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety during the active phase, second stage, and postpartum
Time Frame: during the labor
assessed with VAS
during the labor
pain during second stage, and during postpartum
Time Frame: during the labor
pain assessed with VAS
during the labor
postpartum depression
Time Frame: at the time of delivery
incidence of postpartum depression
at the time of delivery
episiotomy and lacerations
Time Frame: at the time of delivery
incidence of episiotomy and lacerations
at the time of delivery
analgesia
Time Frame: at the time of delivery
use of analgesia
at the time of delivery
labor length
Time Frame: during labor
length of first stage, and second stage of labor
during labor
neonatal outcomes
Time Frame: at the time of delivery until 28days of life
admission to NICU, neonatal death, a composite of outcomes including NEC, IVH, RDS, BPD, ROP, sepsis, N1CU and death. Multiple measurements (i.e. for composite perinatal outcome) will be aggregated to arrive at one reported value (i.e. incidence of composite perianatal outcome)
at the time of delivery until 28days of life

Collaborators and Investigators

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

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 22, 2018

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

September 15, 2019

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 278/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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