NCT01049477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 8, 2017

Status Verified

December 1, 2014

Enrollment Period

6.3 years

First QC Date

January 13, 2010

Last Update Submit

November 6, 2017

Conditions

PregnancyCesarean Section

Keywords

PregnancyCesarean Section

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Music therapy

EXPERIMENTAL

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 groupOther: Non music group

No music group

NO INTERVENTION

Subjects will not listen to music before and after c/s. STAI will be completed pre and post operatively.

Interventions

Music groupOTHER

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.

Music therapy
Non music groupOTHER

Patients randomized to the non music group will complete the STAI before and after their c/s, but not listen to music.

Music therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    PMID: 32871021DERIVED

Study Officials

  • Heather Mertz, MD

    Wake Forest University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 8, 2017

Record last verified: 2014-12

Locations

US(1)