Effect of Music on Stress and Delivery

NCT ID: NCT03348358

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2020-12-31

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.

Conditions

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Stress Delivery Problem for Fetus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control

No music during labor

Group Type PLACEBO_COMPARATOR

control

Intervention Type BEHAVIORAL

No music during labor

Quiet music

Women hearing quiet music during labor

Group Type EXPERIMENTAL

quiet music

Intervention Type BEHAVIORAL

playing quiet music during labor

Rhythmic music

Women hearing rhythmic music during labor

Group Type EXPERIMENTAL

Rhythmic music

Intervention Type BEHAVIORAL

playing rhythmic music during labor

Interventions

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quiet music

playing quiet music during labor

Intervention Type BEHAVIORAL

Rhythmic music

playing rhythmic music during labor

Intervention Type BEHAVIORAL

control

No music during labor

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yael Pasternak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir Medical center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Yael Pasternak, MD

Role: primary

+972525517521

Other Identifiers

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Music in delivery room

Identifier Type: -

Identifier Source: org_study_id

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