Labor PainNCT03779386
Trial of Music During Labor and Delivery
A study testing music in people with Labor Pain, run by Federico II University at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 22 Dec 2018to 15 Sep 2019
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- multiple gestations;
- preterm labor;
- preterm premature rupture of membranes
- induction to delivery labor;
- Hipertensive disorders;
- fetal abnormalities;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music During Labor and Delivery: Randomized Controlled Trial
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.
- Conditions
- Labor Pain
- Being tested
- music
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
music during labor and delivery
| Study group | Role | What they receive |
|---|---|---|
| Music during labor and delivery | Experimental | Music during labor and delivery Receives: Other: music |
| No music during labor and delivery | No intervention | No music during labor and delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during the active phase
pain assessed with VAS
Measured: during the labor
Secondary outcomes (7)
anxiety during the active phase, second stage, and postpartum
assessed with VAS
Measured: during the labor
pain during second stage, and during postpartum
pain assessed with VAS
Measured: during the labor
postpartum depression
incidence of postpartum depression
Measured: at the time of delivery
episiotomy and lacerations
incidence of episiotomy and lacerations
Measured: at the time of delivery
analgesia
use of analgesia
Measured: at the time of delivery
labor length
length of first stage, and second stage of labor
Measured: during labor
neonatal outcomes
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)
Measured: at the time of delivery until 28days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start22 Dec 2018
- Primary completion15 Jul 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779386
- Sponsor's protocol ID
- 278/18
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buglione A, Saccone G, Mas M, Raffone A, Di Meglio L, di Meglio L, Toscano P, Travaglino A, Zapparella R, Duval M, Zullo F, Locci M. Effect of music on labor and delivery in nulliparous singleton pregnancies: a randomized clinical trial. Arch Gynecol Obstet. 2020 Mar;301(3):693-698. doi: 10.1007/s00404-020-05475-9. Epub 2020 Mar 3.
PubMed 32125522
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music During Labor and Delivery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03779386
- Acronym / sponsor ID
- 278/18
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 22 Dec 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 19 Dec 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music during labor and delivery | Experimental | Other: musicMusic during labor and delivery |
| No music during labor and delivery | No intervention | –No music during labor and delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- singleton gestations;
- term of phisiological pregnancy
- spontaneous labor
- diagnosis of active phase of labor;
- nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
Key exclusion criteria (13 listed)
- multiple gestations;
- preterm labor;
- preterm premature rupture of membranes
- induction to delivery labor;
- Hipertensive disorders;
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 |
|---|---|---|
| musicmusic during labor and delivery | Other | Music during labor and delivery |
Primary outcome
pain during the active phase
Time frame: during the labor
pain assessed with VAS
7 secondary outcomes
anxiety during the active phase, second stage, and postpartum
Time frame: during the labor
pain during second stage, and during postpartum
Time frame: during the labor
postpartum depression
Time frame: at the time of delivery
episiotomy and lacerations
Time frame: at the time of delivery
analgesia
Time frame: at the time of delivery
labor length
Time frame: during labor
neonatal outcomes
Time frame: at the time of delivery until 28days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 32125522Buglione A, Saccone G, Mas M, Raffone A, Di Meglio L, di Meglio L, Toscano P, Travaglino A, Zapparella R, Duval M, Zullo F, Locci M. Effect of music on labor and delivery in nulliparous singleton pregnancies: a randomized clinical trial. Arch Gynecol Obstet. 2020 Mar;301(3):693-698. doi: 10.1007/s00404-020-05475-9. Epub 2020 Mar 3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 8 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during the active phase (time frame: during the labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779386, which also lists 1 linked publication.
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 8 Oct 2020.