Effect of Music on Stress and Delivery

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03348358
• Other study ID #: Music in delivery room
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2017
• Last updated: March 25, 2018
• Start date: January 23, 2018
• Est. completion date: December 2020

Study information

• Verified date: March 2018
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Secondary outcomes to be examined are obstetric and perinatal outcomes

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age 18-45

• single embryo

• term labor, >=37 weeks of gestation

Exclusion Criteria:

• multiple embryos

• Antepartum fetal death

• preterm delivery

Related Conditions & MeSH terms

• Delivery Problem for Fetus
• Dystocia
• Stress

Intervention

Behavioral:
• quiet music
playing quiet music during labor
• Rhythmic music
playing rhythmic music during labor
• control
No music during labor

Locations

Country	Name	City	State
Israel	Meir Medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective stress	Stress as measured by saliva cortisol	An hour after administration to delivery room
Primary	Subjective stress	Stress as measured by questionnaires	An hour after administration to delivery room
Secondary	Mode of delivery	Cesarean delivery/ vaginal delivery/ operative delivery	through study completion, an average of 1 year