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Completed

NCT Number: NCT03779386

Trial of Music During Labor and Delivery

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gabriele Saccone

Naples, 80129, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

Other

music during labor and delivery

Primary outcomes

  1. pain during the active phase

    Time frame: during the labor

    pain assessed with VAS

Secondary outcomes

  1. anxiety during the active phase, second stage, and postpartum

    Time frame: during the labor

    assessed with VAS

  2. pain during second stage, and during postpartum

    Time frame: during the labor

    pain assessed with VAS

  3. postpartum depression

    Time frame: at the time of delivery

    incidence of postpartum depression

  4. episiotomy and lacerations

    Time frame: at the time of delivery

    incidence of episiotomy and lacerations

  5. analgesia

    Time frame: at the time of delivery

    use of analgesia

  6. labor length

    Time frame: during labor

    length of first stage, and second stage of labor

  7. neonatal outcomes

    Time frame: at the time of delivery until 28days of life

    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)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Music During Labor and Delivery: Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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