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

Study Overview
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Other: music in labor


Participation Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MUSIC<br>music in labor | Other: music in labor<br>* 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<br>|
| No Intervention: control<br>no music during labor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean pain level during the active phase of labor | assessed by Visual Analog Scale (VAS) for Pain | at the time of the active phase of labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean anxiety level during the active phase of labor, second stage, and at post-partum | assessed by Visual Analog Scale (VAS) for anxiety | at the time of the active phase of labor |