Trial of Music During Labor and Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-22

Study Completion Date

2019-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Music during labor and delivery

Group Type EXPERIMENTAL

music

Intervention Type OTHER

music during labor and delivery

No music during labor and delivery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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music

music during labor and delivery

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes