Clinical trial NCT03779386: Trial of Music During Labor and Delivery
Official title: Music During Labor and Delivery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
* 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.

Primary outcomes:
measure: pain during the active phase
timeFrame: during the labor
Secondary outcomes:
measure: anxiety during the active phase, second stage, and postpartum
timeFrame: during the labor
measure: pain during second stage, and during postpartum
timeFrame: during the labor
measure: postpartum depression
timeFrame: at the time of delivery
measure: episiotomy and lacerations
timeFrame: at the time of delivery
measure: analgesia
timeFrame: at the time of delivery
measure: labor length
timeFrame: during labor
measure: neonatal outcomes
timeFrame: at the time of delivery until 28days of life
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
References:
citation: Buglione A, Saccone G, Mas M, Raffone A, Di Meglio L, di Meglio L, Toscano P, Travaglino A, Zapparella R, Duval M, Zullo F, Locci M. Effect of music on labor and delivery in nulliparous singleton pregnancies: a randomized clinical trial. Arch Gynecol Obstet. 2020 Mar;301(3):693-698. doi: 10.1007/s00404-020-05475-9. Epub 2020 Mar 3.