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

November 6, 2017 updated by: Wake Forest University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before and after cesarean delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Investigators

  • Principal Investigator: Heather Mertz, MD, Wake Forest University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMC 2007-0906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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