Trial of Music During Labor and Delivery

Labor Pain Clinical Trial

Official title:

Music During Labor and Delivery: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779386
• Other study ID #: 278/18
• Status: Completed
• Phase: N/A
• Start date: December 22, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: December 2019
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Other:
• music
music during labor and delivery

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain during the active phase	pain assessed with VAS	during the labor
Secondary	anxiety during the active phase, second stage, and postpartum	assessed with VAS	during the labor
Secondary	pain during second stage, and during postpartum	pain assessed with VAS	during the labor
Secondary	postpartum depression	incidence of postpartum depression	at the time of delivery
Secondary	episiotomy and lacerations	incidence of episiotomy and lacerations	at the time of delivery
Secondary	analgesia	use of analgesia	at the time of delivery
Secondary	labor length	length of first stage, and second stage of labor	during labor
Secondary	neonatal outcomes	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