Labor PainNCT04662424
Effect of Music in Labor in Women Who Underwent Induction of Labor
A study testing music in labor in people with Labor Pain, run by Federico II University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- music in labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nulliparous women
- Singleton gestation
- Vertex presentation
- Induction of labor, i.e. cervical ripening with prostaglandins
- Gestational age between 37 and 42 weeks
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gabriele Saccone
Naples, 80129
Gabriele Saccone, 3394685179, gabriele.saccone@libero.it
About this study
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.
- Conditions
- Labor Pain
- Being tested
- music in labor
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music in laborOther
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
| Study group | Role | What they receive |
|---|---|---|
| MUSIC | Experimental | music in labor Receives: Other: music in labor |
| control | No intervention | no music during labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pain level during the active phase of labor
assessed by Visual Analog Scale (VAS) for Pain
Measured: at the time of the active phase of labor
Secondary outcomes (1)
Mean anxiety level during the active phase of labor, second stage, and at post-partum
assessed by Visual Analog Scale (VAS) for anxiety
Measured: at the time of the active phase of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start3 Dec 2020
- Primary completion20 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
- Investigators
- Gabriele Saccone, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662424
- Sponsor's protocol ID
- 301/20
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: unplanned
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music in Labor in Women Who Underwent Induction of Labor
- ClinicalTrials.gov ID
- NCT04662424
- Acronym / sponsor ID
- 301/20
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 20 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUSIC | Experimental | Other: music in labormusic in labor |
| control | No intervention | –no music during labor |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Nulliparous women
- Singleton gestation
- Vertex presentation
- Induction of labor, i.e. cervical ripening with prostaglandins
- Gestational age between 37 and 42 weeks
Key exclusion criteria (7 listed)
- Multiparous womne
- Multiple gestations
- Preterm labor
- Preterm premature rupture of membranes
- Induction of labor with oxytocin and without prostaglandins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music in laborWomen 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 | Other | MUSIC |
Primary outcome
mean pain level during the active phase of labor
Time frame: at the time of the active phase of labor
assessed by Visual Analog Scale (VAS) for Pain
1 secondary outcome
Mean anxiety level during the active phase of labor, second stage, and at post-partum
Time frame: at the time of the active phase of labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: Undecided. unplanned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Saccone, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in labor in people with Labor Pain, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Saccone, MD (0817461111, gabriele.saccone@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean pain level during the active phase of labor (time frame: at the time of the active phase of labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.