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Effect of Music on Stress and Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348358
Recruitment Status : Unknown
Verified March 2018 by Yael Pasternak, Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : November 20, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yael Pasternak, Meir Medical Center

Study Description
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Brief 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. Secondary outcomes to be examined are obstetric and perinatal outcomes

Condition or disease Intervention/treatment Phase
Stress Delivery Problem for Fetus Behavioral: quiet music Behavioral: Rhythmic music Behavioral: control Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: control
No music during labor
 Behavioral: control
No music during labor
Experimental: Quiet music
Women hearing quiet music during labor
 Behavioral: quiet music
playing quiet music during labor
Experimental: Rhythmic music
Women hearing rhythmic music during labor
 Behavioral: Rhythmic music
playing rhythmic music during labor


Outcome Measures
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Primary Outcome Measures :
  1. Objective stress [ Time Frame: An hour after administration to delivery room ]
    Stress as measured by saliva cortisol

  2. Subjective stress [ Time Frame: An hour after administration to delivery room ]
    Stress as measured by questionnaires


Secondary Outcome Measures :
  1. Mode of delivery [ Time Frame: through study completion, an average of 1 year ]
    Cesarean delivery/ vaginal delivery/ operative delivery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-45
  • single embryo
  • term labor, >=37 weeks of gestation

Exclusion Criteria:

  • multiple embryos
  • Antepartum fetal death
  • preterm delivery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348358


Locations
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Israel
Meir Medical center Recruiting
Kfar Saba, Israel
Contact: Yael Pasternak, MD    +972525517521    yaeli.pasternak@gmail.com   
Sponsors and Collaborators
Meir Medical Center
More Information
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Responsible Party: Yael Pasternak, Principal Investigator, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03348358    
Other Study ID Numbers: Music in delivery room
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dystocia
Obstetric Labor Complications
Pregnancy Complications