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Effect of Music in Labor in Women Who Underwent Induction of Labor

NCT ID: NCT04662424

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2021-03-01

Brief Summary

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Women's experience of pain during labor varies greatly, and pain control is a major concern for obstetricians. Several methods have been studied for pain management for women in labor, including drug and non-drug interventions Most methods of non-pharmacological pain management are non-invasive and appear to be safe for mother and baby, including immersion in water, relaxation, acupuncture, and massage. However, their efficacy is unclear, and based mostly on non-randomized studies. On the other hand, there are strong data to support the efficacy of pharmacological methods, including epidural analgesia, which improves pain relief but increase the incidence of operative vaginal delivery Recently a clinical trial showed that music in labor was associated with maternal benefits in women who underwent spontaneous vaginal delivery. However, the effect of music in labor in women undergoing induction of labor is still a subject of debate.

Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MUSIC

music in labor

Group Type EXPERIMENTAL

music in labor

Intervention Type OTHER

Women in the intervention group will be offered music in labor, defined listening to music from the randomization until the delivery of the baby. Women had the possibility to select the songs at their discretion

control

no music during labor

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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music in labor

Women in the intervention group will be offered music in labor, defined listening to music from the randomization until the delivery of the baby. Women had the possibility to select the songs at their discretion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Nulliparous women
* Singleton gestation
* Vertex presentation
* Induction of labor, i.e. cervical ripening with prostaglandins
* Gestational age between 37 and 42 weeks

Exclusion Criteria

* Multiparous womne
* Multiple gestations
* Preterm labor
* Preterm premature rupture of membranes
* Induction of labor with oxytocin and without prostaglandins
* Induction of labor with balloon
* High risk pregnancies, including hypertensive disorders of pregnancies, diabetes, intrauterine growth restriction, fetal abnormalities.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Saccone

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriele Saccone, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Gabriele Saccone

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gabriele Saccone, MD

Role: CONTACT

Phone: 0817461111

Email: [email protected]

Facility Contacts

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Gabriele Saccone

Role: primary

Other Identifiers

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301/20

Identifier Type: -

Identifier Source: org_study_id