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?

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

Study Overview

• Status: Unknown
• Conditions: Stress; Delivery Problem for Fetus
• Intervention / Treatment: Behavioral: control; Behavioral: quiet music; Behavioral: Rhythmic music

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: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Yael Pasternak, MD; Phone Number: +972525517521; Email: yaeli.pasternak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: October 1, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (ACTUAL): November 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 25, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia
• Other Study ID Numbers: Music in delivery room

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No