NCT03348358

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

October 1, 2017

Last Update Submit

March 25, 2018

Conditions

StressDelivery Problem for Fetus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Mode of delivery

    through study completion, an average of 1 year

Study Arms (3)

control

PLACEBO COMPARATOR

No music during labor

Behavioral: control

Quiet music

EXPERIMENTAL

Women hearing quiet music during labor

Behavioral: quiet music

Rhythmic music

EXPERIMENTAL

Women hearing rhythmic music during labor

Behavioral: Rhythmic music

Interventions

quiet musicBEHAVIORAL

playing quiet music during labor

Quiet music
Rhythmic musicBEHAVIORAL

playing rhythmic music during labor

Rhythmic music
controlBEHAVIORAL

No music during labor

control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • multiple embryos
  • Antepartum fetal death
  • preterm delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical center

Kfar Saba, Israel

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2017

First Posted

November 20, 2017

Study Start

January 23, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

IL(1)