Effect of Music in Labor in Women Who Underwent Induction of Labor
Primary Purpose
Labor Pain
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
music in labor
Sponsored by
About this trial
This is an interventional prevention trial for Labor Pain
Eligibility Criteria
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.
Sites / Locations
- Gabriele SacconeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MUSIC
control
Arm Description
music in labor
no music during labor
Outcomes
Primary Outcome Measures
mean pain level during the active phase of labor
assessed by Visual Analog Scale (VAS) for Pain
Secondary Outcome Measures
Mean anxiety level during the active phase of labor, second stage, and at post-partum
assessed by Visual Analog Scale (VAS) for anxiety
Full Information
NCT ID
NCT04662424
First Posted
December 3, 2020
Last Updated
December 9, 2020
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT04662424
Brief Title
Effect of Music in Labor in Women Who Underwent Induction of Labor
Official Title
Effect of Music in Labor in Women Who Underwent Induction of Labor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
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
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.
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MUSIC
Arm Type
Experimental
Arm Description
music in labor
Arm Title
control
Arm Type
No Intervention
Arm Description
no music during labor
Intervention Type
Other
Intervention Name(s)
music in labor
Intervention Description
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
Primary Outcome Measure Information:
Title
mean pain level during the active phase of labor
Description
assessed by Visual Analog Scale (VAS) for Pain
Time Frame
at the time of the active phase of labor
Secondary Outcome Measure Information:
Title
Mean anxiety level during the active phase of labor, second stage, and at post-partum
Description
assessed by Visual Analog Scale (VAS) for anxiety
Time Frame
at the time of the active phase of labor
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriele Saccone, MD
Phone
0817461111
Email
gabriele.saccone@unina.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Saccone, MD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gabriele Saccone
City
Napoli
ZIP/Postal Code
80129
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Saccone
Phone
3394685179
Email
gabriele.saccone@libero.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
unplanned
Learn more about this trial
Effect of Music in Labor in Women Who Underwent Induction of Labor
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