Trial of Music During Labor and Delivery

NCT03779386 | Completed

• 1 other identifier: 278/18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• pain during the active phase

  pain assessed with VAS

  during the labor

Secondary Outcomes (7)

• anxiety during the active phase, second stage, and postpartum

  during the labor

• pain during second stage, and during postpartum

  during the labor

• postpartum depression

  at the time of delivery

• episiotomy and lacerations

  at the time of delivery

• analgesia

  at the time of delivery

Study Arms (2)

Music during labor and delivery

EXPERIMENTAL

Music during labor and delivery

Other: music

No music during labor and delivery

NO INTERVENTION

No music during labor and delivery

Interventions

music OTHER

music during labor and delivery

Music during labor and delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Napoli, 80129, Italy

Location

Related Publications (1)

• 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.

  PMID: 32125522 DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: December 22, 2018
• Primary Completion: July 15, 2019
• Study Completion: September 15, 2019
• Last Updated: October 8, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)