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Clinical Trials/NCT03779386
NCT03779386
Completed
Not Applicable

Music During Labor and Delivery: Randomized Controlled Trial

Federico II University1 site in 1 country30 target enrollmentDecember 22, 2018
ConditionsLabor Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Pain
Sponsor
Federico II University
Enrollment
30
Locations
1
Primary Endpoint
pain during the active phase
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 22, 2018
End Date
September 15, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Gabriele Saccone

Principal Investigator

Federico II University

Eligibility Criteria

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;

Outcomes

Primary Outcomes

pain during the active phase

Time Frame: during the labor

pain assessed with VAS

Secondary Outcomes

  • pain during second stage, and during postpartum(during the labor)
  • anxiety during the active phase, second stage, and postpartum(during the labor)
  • neonatal outcomes(at the time of delivery until 28days of life)
  • episiotomy and lacerations(at the time of delivery)
  • labor length(during labor)
  • postpartum depression(at the time of delivery)
  • analgesia(at the time of delivery)

Study Sites (1)

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