- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348358
Effect of Music on Stress and Delivery
How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
Contact:
- Yael Pasternak, MD
- Phone Number: +972525517521
- Email: yaeli.pasternak@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18-45
- single embryo
- term labor, >=37 weeks of gestation
Exclusion Criteria:
- multiple embryos
- Antepartum fetal death
- preterm delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: control
No music during labor
|
No music during labor
|
EXPERIMENTAL: Quiet music
Women hearing quiet music during labor
|
playing quiet music during labor
|
EXPERIMENTAL: Rhythmic music
Women hearing rhythmic music during labor
|
playing rhythmic music during labor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective stress
Time Frame: An hour after administration to delivery room
|
Stress as measured by saliva cortisol
|
An hour after administration to delivery room
|
Subjective stress
Time Frame: An hour after administration to delivery room
|
Stress as measured by questionnaires
|
An hour after administration to delivery room
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mode of delivery
Time Frame: through study completion, an average of 1 year
|
Cesarean delivery/ vaginal delivery/ operative delivery
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Music in delivery room
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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