StressNCT03348358
Effect of Music on Stress and Delivery
A study testing quiet music and Rhythmic music in people with Stress and Delivery Problem for Fetus, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaires, respectively. 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
- Stress, Delivery Problem for Fetus
- What is being tested?
- quiet music and Rhythmic music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jan 2018to Dec 2020
- 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
- age 18-45
- single embryo
- term labor, >=37 weeks of gestation
Who cannot join
- multiple embryos
- Antepartum fetal death
- preterm delivery
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical center
Kfar Saba
Yael Pasternak, MD, +972525517521, yaeli.pasternak@gmail.com
About this study
Official title: How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?
The purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaires, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes
Read the detailed description
For centuries, music has been known to have therapeutic effects on the body and the mind A large body of findings is related to the therapeutic potential of music in clinical settings, mainly among patients undergoing surgical and dental procedures, and also in other medical environments, such as intensive care, psychiatry, and geriatrics. Using music interventions in clinical settings was associated with reductions in negative effects in addition to objective stress and anxiety indices such as reduced heart rate, blood pressure, myocardial oxygen consumption, gastrointestinal function, anxiety, pain, and increased oxytocin levels.
One study found that women who listened to music before a cesarean section had a significant increase in positive emotions and a significant reduction in systolic blood pressure compared with a significant increase in diastolic blood pressure and respiratory rate in the control group. Li and Dong concluded in a different study, that preoperative music intervention can reduce anxiety and pain in women undergoing cesarean delivery.
Various studies examined the relation of music during labor to pain relief. One study found that the group of women going through music therapy had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labor. One randomly assigned study found that women listened to soft music starting early in the active phase of labor had decreased sensation and distress of active labor pain. To date, no study examined the level of salivary cortisol while music is played at delivery room as an objective estimation of the stress level.
In addition to that, there is a lack of information regarding the effect of music during labor on the obstetric and perinatal outcomes.
Therefore, the purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaire, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes.
- Conditions
- Stress, Delivery Problem for Fetus
- Being tested
- quiet music, Rhythmic music, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quiet musicBehavioural
playing quiet music during labor
Rhythmic musicBehavioural
playing rhythmic music during labor
controlBehavioural
No music during labor
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | No music during labor Receives: Behavioral: control |
| Quiet music | Experimental | Women hearing quiet music during labor Receives: Behavioral: quiet music |
| Rhythmic music | Experimental | Women hearing rhythmic music during labor Receives: Behavioral: Rhythmic music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective stress
Stress as measured by saliva cortisol
Measured: An hour after administration to delivery room
Subjective stress
Stress as measured by questionnaires
Measured: An hour after administration to delivery room
Secondary outcomes (1)
Mode of delivery
Cesarean delivery/ vaginal delivery/ operative delivery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start23 Jan 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Pasternak, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348358
- Sponsor's protocol ID
- Music in delivery room
- Status last verified
- Mar 2018
- First submitted
- 1 Oct 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?
- ClinicalTrials.gov ID
- NCT03348358
- Acronym / sponsor ID
- Music in delivery room
- Conditions
- Stress, Delivery Problem for Fetus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Nov 2017 (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 purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaires, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes
Detailed description
For centuries, music has been known to have therapeutic effects on the body and the mind A large body of findings is related to the therapeutic potential of music in clinical settings, mainly among patients undergoing surgical and dental procedures, and also in other medical environments, such as intensive care, psychiatry, and geriatrics. Using music interventions in clinical settings was associated with reductions in negative effects in addition to objective stress and anxiety indices such as reduced heart rate, blood pressure, myocardial oxygen consumption, gastrointestinal function, anxiety, pain, and increased oxytocin levels.
One study found that women who listened to music before a cesarean section had a significant increase in positive emotions and a significant reduction in systolic blood pressure compared with a significant increase in diastolic blood pressure and respiratory rate in the control group. Li and Dong concluded in a different study, that preoperative music intervention can reduce anxiety and pain in women undergoing cesarean delivery.
Various studies examined the relation of music during labor to pain relief. One study found that the group of women going through music therapy had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labor. One randomly assigned study found that women listened to soft music starting early in the active phase of labor had decreased sensation and distress of active labor pain. To date, no study examined the level of salivary cortisol while music is played at delivery room as an objective estimation of the stress level.
In addition to that, there is a lack of information regarding the effect of music during labor on the obstetric and perinatal outcomes.
Therefore, the purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaire, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Behavioral: controlNo music during labor |
| Quiet music | Experimental | Behavioral: quiet musicWomen hearing quiet music during labor |
| Rhythmic music | Experimental | Behavioral: Rhythmic musicWomen hearing rhythmic music during labor |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-45
- single embryo
- term labor, >=37 weeks of gestation
Key exclusion criteria (3 listed)
- multiple embryos
- Antepartum fetal death
- preterm delivery
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 |
|---|---|---|
| quiet musicplaying quiet music during labor | Behavioural | Quiet music |
| Rhythmic musicplaying rhythmic music during labor | Behavioural | Rhythmic music |
| controlNo music during labor | Behavioural | control |
Primary outcome
Objective stress
Time frame: An hour after administration to delivery room
Stress as measured by saliva cortisol
Subjective stress
Time frame: An hour after administration to delivery room
Stress as measured by questionnaires
1 secondary outcome
Mode of delivery
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quiet music and Rhythmic music in people with Stress and Delivery Problem for Fetus, run by Meir Medical Center at 1 site in Israel.
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 3 inclusion and 3 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 27 Mar 2018. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective stress (time frame: An hour after administration to delivery room). The study lists 2 primary outcomes in all. 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 27 Mar 2018.