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
  Purpose

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.


Condition Intervention
Pregnancy
Cesarean Section
Other: Music group
Other: Non music group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Non Music group
The non music group will only complete the STAI form.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049477

Contacts
Contact: Heather Mertz, MD 336-716-1025 hmertz@wfubmc.edu
Contact: Patricia Scott, MD 336-716-1025 plscott@wfubmc.edu

Locations
United States, North Carolina
Forsyth Medical Center Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Beth Cirillo, CCRC    336-718-5964    bjcirillo@novanthealth.org   
Contact: Melissa Pritchard    336-718-5964    mpritchard@novanthealth.org   
Principal Investigator: Heather Mertz, MD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Heather Mertz, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Dr. Heather Mertz, Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT01049477     History of Changes
Other Study ID Numbers: FMC 2007-0906
Study First Received: January 13, 2010
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Pregnancy
Cesarean Section

ClinicalTrials.gov processed this record on April 17, 2014