Stress Clinical Trial
Official title:
How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?
Verified date | March 2018 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Meir Medical center | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
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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