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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01049477
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : November 8, 2017
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Cesarean Section Other: Music group Other: Non music group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery
Study Start Date : September 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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.

No Intervention: No music group
Subjects will not listen to music before and after c/s. STAI will be completed pre and post operatively.

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01049477

United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Heather Mertz, MD Wake Forest University

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Responsible Party: Wake Forest University Identifier: NCT01049477     History of Changes
Other Study ID Numbers: FMC 2007-0906
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: December 2014

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Cesarean Section