Effect of Music on Stress and Delivery
Primary Purpose
Stress, Delivery Problem for Fetus
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
quiet music
Rhythmic music
control
Sponsored by
About this trial
This is an interventional supportive care trial for Stress
Eligibility Criteria
Inclusion Criteria:
- age 18-45
- single embryo
- term labor, >=37 weeks of gestation
Exclusion Criteria:
- multiple embryos
- Antepartum fetal death
- preterm delivery
Sites / Locations
- Meir Medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
control
Quiet music
Rhythmic music
Arm Description
No music during labor
Women hearing quiet music during labor
Women hearing rhythmic music during labor
Outcomes
Primary Outcome Measures
Objective stress
Stress as measured by saliva cortisol
Subjective stress
Stress as measured by questionnaires
Secondary Outcome Measures
Mode of delivery
Cesarean delivery/ vaginal delivery/ operative delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03348358
Brief Title
Effect of Music on Stress and Delivery
Official Title
How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Delivery Problem for Fetus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
No music during labor
Arm Title
Quiet music
Arm Type
Experimental
Arm Description
Women hearing quiet music during labor
Arm Title
Rhythmic music
Arm Type
Experimental
Arm Description
Women hearing rhythmic music during labor
Intervention Type
Behavioral
Intervention Name(s)
quiet music
Intervention Description
playing quiet music during labor
Intervention Type
Behavioral
Intervention Name(s)
Rhythmic music
Intervention Description
playing rhythmic music during labor
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
No music during labor
Primary Outcome Measure Information:
Title
Objective stress
Description
Stress as measured by saliva cortisol
Time Frame
An hour after administration to delivery room
Title
Subjective stress
Description
Stress as measured by questionnaires
Time Frame
An hour after administration to delivery room
Secondary Outcome Measure Information:
Title
Mode of delivery
Description
Cesarean delivery/ vaginal delivery/ operative delivery
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-45
single embryo
term labor, >=37 weeks of gestation
Exclusion Criteria:
multiple embryos
Antepartum fetal death
preterm delivery
Facility Information:
Facility Name
Meir Medical center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yael Pasternak, MD
Phone
+972525517521
Email
yaeli.pasternak@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Music on Stress and Delivery
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