The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery
Recruitment status was Recruiting
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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 |
- 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 |
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.
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Contacts and Locations| Contact: Heather Mertz, MD | 336-716-1025 | hmertz@wfubmc.edu |
| Contact: Patricia Scott, MD | 336-716-1025 | plscott@wfubmc.edu |
| 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 | |
| Principal Investigator: | Heather Mertz, MD | Wake Forest University |
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 University:
|
Pregnancy Cesarean Section |
ClinicalTrials.gov processed this record on May 16, 2013