Skip to content

Trial of Music During Labor and Delivery

Music During Labor and Delivery: Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03779386
Enrollment
30
Registered
2018-12-19
Start date
2018-12-22
Completion date
2019-09-15
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

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.

Interventions

OTHERmusic

music during labor and delivery

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
pain during the active phaseduring the laborpain assessed with VAS

Secondary

MeasureTime frameDescription
pain during second stage, and during postpartumduring the laborpain assessed with VAS
postpartum depressionat the time of deliveryincidence of postpartum depression
episiotomy and lacerationsat the time of deliveryincidence of episiotomy and lacerations
anxiety during the active phase, second stage, and postpartumduring the laborassessed with VAS
labor lengthduring laborlength of first stage, and second stage of labor
neonatal outcomesat the time of delivery until 28days of lifeadmission 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)
analgesiaat the time of deliveryuse of analgesia

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026