NCT03024411

Brief Summary

Data are lacking regarding the use of music and video games for the management of pain in labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks will be approached for participation in the study. Patients will be randomized to a music/video games group and a non-music/video games group. Those randomized to group with music/video games will be given an iPod for those purposes.The primary outcome will be the time for patients to request pain medications after Foley bulb placement. The two groups will be compared for differences in pain outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

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

First Submitted

Initial submission to the registry

March 14, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

March 14, 2016

Last Update Submit

February 6, 2018

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Time until patient request for pain medication after Foley bulb placement.

    Time from Foley bulb placement until patient requests pain medication.

    From time of Foley bulb placement (randomization) until time of request for pain medicine or time of delivery, whichever came first, assessed up to 3 days.

Secondary Outcomes (2)

  • Parenteral medication

    From time of Foley bulb placement (randomization) until time of delivery, assessed up to 3 days.

  • Visual analog scale (VAS) pain score

    Six hours from time of Foley bulb placement (randomization).

Study Arms (2)

Music/video games

EXPERIMENTAL

iPod (Music/video games)

Other: iPod (Music/video games)

No intervention

NO INTERVENTION

No intervention

Interventions

iPod (Music/video games)OTHER

Experimental patients will be given an iPod to enjoy music/video games during induction of labor.

Music/video games

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years old
  • Pregnant women \> or = 37 weeks gestation
  • Induction of labor using Foley bulb
  • Singleton gestation
  • Vertex fetal presentation
  • Intact membranes

You may not qualify if:

  • Any contraindication for vaginal delivery (malpresentation, placenta previa)
  • Previous cesarean section
  • Gestational age \<37 weeks gestation
  • Receiving pain medication at time of Foley bulb placement
  • Chronic narcotic use (methadone, suboxone, oxycodone, etc.)
  • Visual or auditory impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77553, United States

Location

Related Publications (22)

  • Smith CA, Levett KM, Collins CT, Crowther CA. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD009514. doi: 10.1002/14651858.CD009514.

    PMID: 22161453BACKGROUND

  • van der Heijden MJ, Oliai Araghi S, van Dijk M, Jeekel J, Hunink MG. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Aug 6;10(8):e0133608. doi: 10.1371/journal.pone.0133608. eCollection 2015.

    PMID: 26247769BACKGROUND

  • Hsieh C, Kong J, Kirsch I, Edwards RR, Jensen KB, Kaptchuk TJ, Gollub RL. Well-loved music robustly relieves pain: a randomized, controlled trial. PLoS One. 2014 Sep 11;9(9):e107390. doi: 10.1371/journal.pone.0107390. eCollection 2014.

    PMID: 25211164BACKGROUND

  • Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.

    PMID: 23857075BACKGROUND

  • Primack BA, Carroll MV, McNamara M, Klem ML, King B, Rich M, Chan CW, Nayak S. Role of video games in improving health-related outcomes: a systematic review. Am J Prev Med. 2012 Jun;42(6):630-8. doi: 10.1016/j.amepre.2012.02.023.

    PMID: 22608382BACKGROUND

  • MOORE WM, BROWNE JC, HILL ID. CLINICAL TRIAL OF AUDIO-ANALGESIA IN CHILDBIRTH. J Obstet Gynaecol Br Commonw. 1965 Aug;72:626-9. doi: 10.1111/j.1471-0528.1965.tb00074.x. No abstract available.

    PMID: 14341119BACKGROUND

  • Yinger OS, Gooding LF. A systematic review of music-based interventions for procedural support. J Music Ther. 2015 Spring;52(1):1-77. doi: 10.1093/jmt/thv004. Epub 2015 Apr 15.

    PMID: 25878063BACKGROUND

  • Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.

    PMID: 16625614BACKGROUND

  • Browning CA. Using music during childbirth. Birth. 2000 Dec;27(4):272-6. doi: 10.1046/j.1523-536x.2000.00272.x.

    PMID: 11251514BACKGROUND

  • Akmese ZB, Oran NT. Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy. J Midwifery Womens Health. 2014 Sep-Oct;59(5):503-9. doi: 10.1111/jmwh.12176. Epub 2014 Jun 25.

    PMID: 24965313BACKGROUND

  • Wright J, Adams D, Vohra S. Complementary, holistic, and integrative medicine: music for procedural pain. Pediatr Rev. 2013 Nov;34(11):e42-6. doi: 10.1542/pir.34-11-e42. No abstract available.

    PMID: 24187147BACKGROUND

  • Keenan A, Keithley JK. Integrative Review: Effects of Music on Cancer Pain in Adults. Oncol Nurs Forum. 2015 Nov;42(6):E368-75. doi: 10.1188/15.ONF.E368-E375.

    PMID: 26488843BACKGROUND

  • BURT RK, KORN GW. AUDIOANALGESIA IN OBSTETRICS. "WHITE SOUND" ANALGESIA DURING LABOR. Am J Obstet Gynecol. 1964 Feb 1;88:361-6. No abstract available.

    PMID: 14123408BACKGROUND

  • Tsai HF, Chen YR, Chung MH, Liao YM, Chi MJ, Chang CC, Chou KR. Effectiveness of music intervention in ameliorating cancer patients' anxiety, depression, pain, and fatigue: a meta-analysis. Cancer Nurs. 2014 Nov-Dec;37(6):E35-50. doi: 10.1097/NCC.0000000000000116.

    PMID: 24662723BACKGROUND

  • Bellieni CV, Cioncoloni D, Mazzanti S, Bianchi ME, Morrone I, Becattelli R, Perrone S, Buonocore G. Music provided through a portable media player (iPod) blunts pain during physical therapy. Pain Manag Nurs. 2013 Dec;14(4):e151-e155. doi: 10.1016/j.pmn.2011.09.003. Epub 2011 Nov 16.

    PMID: 24315267BACKGROUND

  • Gutgsell KJ, Schluchter M, Margevicius S, DeGolia PA, McLaughlin B, Harris M, Mecklenburg J, Wiencek C. Music therapy reduces pain in palliative care patients: a randomized controlled trial. J Pain Symptom Manage. 2013 May;45(5):822-31. doi: 10.1016/j.jpainsymman.2012.05.008. Epub 2012 Sep 24.

    PMID: 23017609BACKGROUND

  • Li Y, Dong Y. Preoperative music intervention for patients undergoing cesarean delivery. Int J Gynaecol Obstet. 2012 Oct;119(1):81-3. doi: 10.1016/j.ijgo.2012.05.017. Epub 2012 Jul 15.

    PMID: 22795881BACKGROUND

  • Phumdoung S, Good M. Music reduces sensation and distress of labor pain. Pain Manag Nurs. 2003 Jun;4(2):54-61. doi: 10.1016/s1524-9042(02)54202-8.

    PMID: 12836149BACKGROUND

  • Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x.

    PMID: 20492051BACKGROUND

  • Simavli S, Gumus I, Kaygusuz I, Yildirim M, Usluogullari B, Kafali H. Effect of music on labor pain relief, anxiety level and postpartum analgesic requirement: a randomized controlled clinical trial. Gynecol Obstet Invest. 2014;78(4):244-50. doi: 10.1159/000365085. Epub 2014 Sep 16.

    PMID: 25227477BACKGROUND

  • American College of Obstetrics and Gynecology. ACOG practice bulletin. Obstetric analgesia and anesthesia. Number 36, July 2002. American College of Obstetrics and Gynecology. Int J Gynaecol Obstet. 2002 Sep;78(3):321-35. doi: 10.1016/s0020-7292(02)00268-0.

    PMID: 12452132BACKGROUND

  • Dixon CL, Monsivais L, Chamseddine P, Olson G, Pacheco LD, Saade GR, Costantine MM. The Effect of Distraction during Labor Induction on Timing of Analgesia Request: A Randomized Clinical Trial. Am J Perinatol. 2019 Nov;36(13):1351-1356. doi: 10.1055/s-0038-1676974. Epub 2019 Jan 4.

    PMID: 30609428DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher L Dixon, M.D.

    The University of Texas Medical Branch at Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

January 18, 2017

Study Start

July 8, 2016

Primary Completion

July 8, 2017

Study Completion

August 4, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

US(1)