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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03348358
Other study ID # Music in delivery room
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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