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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049477
• Other study ID #: FMC 2007-0906
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: November 6, 2017
• Start date: September 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (1)

1. Gori F, Pasqualucci A, Corradetti F, et al. Maternal and neonatal outcome after cesarean section: The impact of anesthesia. The Journal of Maternal-Fetal and Neonatal Medicine 2007; 20(1):53-57. 2. Wang S, Kulkarni L, Dolev J, et al. Music and preoperative anxiety: A randomized, controlled study. Anesth Analg 2002; 94(6):1489-1494. 3. Chang S, Chen C. Effects of music therapy on women's physiologic measures, anxiety, and satisfaction during Cesarean delivery. Research in Nursing & Health 2005; 28:453-461. 4. Danhauer SC, Marler B, Rutherford CA, Lovato JF, et al. Music or guided imagery for women undergoing colposcopy: A randomized controlled study of effects on anxiety, perceived pain, and patient satisfaction. J low genit tract dis 2007; 11:39-45. 5. Yung PMB, Kam SC, Lau BWK, et al. The effect of music in managing preoperative stress for Chinese surgical patients in the operating room holding area: A controlled trial. International Journal of Stress Management 2003; 10(1):64-74. 6. Gaberson KB. The effect of humorous and musical distraction on preoperative anxiety. AORN Journal 1995; 62(5):784-791. 7. Pan P, Coghill R, Houle T, et al. Multifactorial and preoperative predictors for postcesarean section pain and analgesic requirement. Anesthesiology 2006; 104:417-425. 8. Maes M, Libbrecht I, Lin A, et al. Effects of pregnancy and delivery on serum prolyl endopeptidase (PEP) activity: alterations in serum PEP are related to increased anxiety in the early puerperium and to postpartum depression. Journal of Affective Disorders 2000; 57:125-137. 9. Zanardo V, Trevisanuto D, and Freato F. Maternal anxiety impairs lactation initiation and maintenance. Pediatrics 2006; 117:1859-1860. 10. Hundley V, Gurney E, Graham W, et al. Can anxiety in pregnant women be measured using the State-Trait Anxiety Inventory? Midwifery 1998; 14:118-121. 11. Man AKY, Yap JCM, Kwan SY, et al. The effect of intra-operative video on patient anxiety. Anesthesia 2003; 58:64-68.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intervention of patient-selected music before and after Cesarean delivery will decrease anxiety levels in a patient population undergoing Cesarean delivery.		Before and after cesarean delivery