Effect of Music on Stress and Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?

Conditions
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Stress, Delivery Problem for Fetus

Intervention / Treatment
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* Behavioral: quiet music
* Behavioral: Rhythmic music
* Behavioral: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-45 single embryo term labor, >=37 weeks of gestation Exclusion Criteria: multiple embryos Antepartum fetal death preterm delivery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>No music during labor | Behavioral: control<br>* No music during labor<br>|
| Experimental: Quiet music<br>Women hearing quiet music during labor | Behavioral: quiet music<br>* playing quiet music during labor<br>|
| Experimental: Rhythmic music<br>Women hearing rhythmic music during labor | Behavioral: Rhythmic music<br>* playing rhythmic music during labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective stress | Stress as measured by saliva cortisol | An hour after administration to delivery room | 
| Subjective stress | Stress as measured by questionnaires | An hour after administration to delivery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Cesarean delivery/ vaginal delivery/ operative delivery | through study completion, an average of 1 year |