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The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Wake Forest School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01049477
First received: January 13, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted

January 13, 2010
January 13, 2010
September 2008
December 2009   (final data collection date for primary outcome measure)
The intervention of patient-selected music before and after Cesarean delivery will decrease anxiety levels in a patient population undergoing Cesarean delivery. [ Time Frame: Before and after cesarean delivery ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery
The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery

The purpose of the study is to determine if listening to your choice of music with a portable mp3 player before and after a cesarean section for delivery of a baby will decrease the patient's anxiety level.

Music has been suggested and evaluated as a therapeutic intervention to reduce preoperative anxiety for surgical patients. Music intervention in the immediate preoperative period may be effective in lowering anxiety levels during Cesarean delivery. If this investigation shows that music intervention before and after Cesarean delivery reduces anxiety levels, this intervention can be integrated into future operative care for women having scheduled or emergency Cesarean deliveries. Music therapy could be expanded to included patients undergoing other surgical procedures under regional anesthesia. The effect of reducing anxiety levels could aid in lactation initiation and improve infant bonding in new mothers, but it could also shorten postoperative recovery time for all surgical patients.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
  • Pregnancy
  • Cesarean Section
  • Other: Music group
    The patients randomized to the music group of the study will listen to music 30 minutes in the holding room prior to their c/s. They will then listen to music after their c/s for 30 minutes. They will complete the STAI before and after their c/s.
  • Other: Non music group
    Patients randomized to the non music group will complete the STAI before and after their c/s, but not listen to music.
  • Experimental: Music therapy
    Experimental arm includes women undergoing cesarean section delivery listening to music before and after c/s. STAI will be completed pre and post operatively.
    Intervention: Other: Music group
  • No Intervention: Non Music group
    The non music group will only complete the STAI form.
    Intervention: Other: Non music group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:Women age 18 and older with a history of one prior Cesarean delivery that are scheduled for a repeat Cesarean delivery under regional anesthesia, or women who are undergoing a primary cesarean section will be eligible to participate.

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Exclusion Criteria:Women with cardiovascular disease, chronic hypertension, insulin dependent diabetes mellitus, multiple gestation pregnancies, psychiatric disorders, and fetal anomaly.

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Female
18 Years to 50 Years
Yes
Contact: Heather Mertz, MD 336-716-1025 hmertz@wfubmc.edu
Contact: Patricia Scott, MD 336-716-1025 plscott@wfubmc.edu
United States
 
NCT01049477
FMC 2007-0906
No
Dr. Heather Mertz, Wake Forest University School of Medicine
Wake Forest School of Medicine
Not Provided
Principal Investigator: Heather Mertz, MD Wake Forest School of Medicine
Wake Forest School of Medicine
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP