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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Mertz, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01049477
First received: January 13, 2010
Last updated: December 29, 2014
Last verified: December 2014
  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 ]

Enrollment: 50
Study Start Date: September 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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.
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Forsyth Medical Center
Winston Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Heather Mertz, MD Wake Forest School of Medicine
  More Information

Publications:
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.

Responsible Party: Heather Mertz, Associate Professor, Wake Forest 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: December 29, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 02, 2015