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Trial of Music During Labor and Delivery

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
music
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Gabriele Saccone

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music during labor and delivery

No music during labor and delivery

Arm Description

Music during labor and delivery

No music during labor and delivery

Outcomes

Primary Outcome Measures

pain during the active phase
pain assessed with VAS

Secondary Outcome Measures

anxiety during the active phase, second stage, and postpartum
assessed with VAS
pain during second stage, and during postpartum
pain assessed with VAS
postpartum depression
incidence of postpartum depression
episiotomy and lacerations
incidence of episiotomy and lacerations
analgesia
use of analgesia
labor length
length of first stage, and second stage of labor
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)

Full Information

First Posted
December 14, 2018
Last Updated
October 7, 2020
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT03779386
Brief Title
Trial of Music During Labor and Delivery
Official Title
Music During Labor and Delivery: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 22, 2018 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music during labor and delivery
Arm Type
Experimental
Arm Description
Music during labor and delivery
Arm Title
No music during labor and delivery
Arm Type
No Intervention
Arm Description
No music during labor and delivery
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
music during labor and delivery
Primary Outcome Measure Information:
Title
pain during the active phase
Description
pain assessed with VAS
Time Frame
during the labor
Secondary Outcome Measure Information:
Title
anxiety during the active phase, second stage, and postpartum
Description
assessed with VAS
Time Frame
during the labor
Title
pain during second stage, and during postpartum
Description
pain assessed with VAS
Time Frame
during the labor
Title
postpartum depression
Description
incidence of postpartum depression
Time Frame
at the time of delivery
Title
episiotomy and lacerations
Description
incidence of episiotomy and lacerations
Time Frame
at the time of delivery
Title
analgesia
Description
use of analgesia
Time Frame
at the time of delivery
Title
labor length
Description
length of first stage, and second stage of labor
Time Frame
during labor
Title
neonatal outcomes
Description
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)
Time Frame
at the time of delivery until 28days of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Gabriele Saccone
City
Napoli
ZIP/Postal Code
80129
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32125522
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.
Results Reference
derived

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Trial of Music During Labor and Delivery

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