NCT04111575

Brief Summary

Musical therapy is a type of therapy which is performed under a regular method by adjusting the physiological and psychological effects of musical tones and melodies in accordance with various situations. Therefore, the study was carried out as a randomized controlled trial in order to evaluate the effect of music therapy on the level of pain and anxiety in the postpartum period in women who delivered via cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

February 5, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

September 27, 2019

Last Update Submit

September 30, 2019

Conditions

Keywords

cesarean sectionMusic therapyAnxietyPain

Outcome Measures

Primary Outcomes (2)

  • State-Trait Anxiety Inventory

    Anxiety level by State-Trait Anxiety Inventory

    On the first and second days after C-section, change from first anxiety level at 30 minutes.The inventory has a Likert type scale of 20 items which aim to measure the state anxiety level.Higher scores indicate greater anxiety

  • Visual Analog Scale (VAS)

    Pain Level by Visual Analog Scale

    On the first and second days after C-section, change from first pain level at 30 minute.The patient marks the pain he/she feels on a scale of 10 cm (100 mm), pain point 1 means "no pain", pain point 10 means "worst pain possible."

Study Arms (3)

music therapy group 1

EXPERIMENTAL

The mothers in the experimental group 1 received music therapy for 30 minutes a day.They listened music for two consecutive days, considering the first day after the C-section as the beginning day.

Behavioral: Music Therapy

music therapy group 2

EXPERIMENTAL

The mothers in the experimental group 1 received music therapy for 30 minutes twice a day. They listened music for two consecutive days, considering the first day after the C-section as the beginning day.

Behavioral: Music Therapy

control group

NO INTERVENTION

the control group were made to rest in bed for 30 minutes a day for two consecutive days, considering the first day after the C-section as the beginning day.

Interventions

Music TherapyBEHAVIORAL

Music Therapy

Also known as: musicotherapy
music therapy group 1music therapy group 2

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being at the age of 18 and above,
  • being healthy,
  • having given a live birth,
  • having no hearing impairment,
  • complication not having developed either in the mother or the baby

You may not qualify if:

  • being at the age of 17 and below,
  • being unhealthy,
  • having given a stillbirth,
  • having hearing impairment,
  • complication having developed either in the mother or the baby

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eylem TOKER

Kahramanmaraş, Dulkadiroglu, 46100, Turkey (Türkiye)

Location

Related Publications (36)

  • Wu J, Chaplin W, Amico J, Butler M, Ojie MJ, Hennedy D, Clemow L. Music for surgical abortion care study: a randomized controlled pilot study. Contraception. 2012 May;85(5):496-502. doi: 10.1016/j.contraception.2011.09.018. Epub 2011 Nov 12.

    PMID: 22079604BACKGROUND
  • Bally K, Campbell D, Chesnick K, Tranmer JE. Effects of patient-controlled music therapy during coronary angiography on procedural pain and anxiety distress syndrome. Crit Care Nurse. 2003 Apr;23(2):50-8. No abstract available.

    PMID: 12725195BACKGROUND
  • Ebneshahidi A, Mohseni M. The effect of patient-selected music on early postoperative pain, anxiety, and hemodynamic profile in cesarean section surgery. J Altern Complement Med. 2008 Sep;14(7):827-31. doi: 10.1089/acm.2007.0752.

    PMID: 18803492BACKGROUND
  • Tournaire M, Theau-Yonneau A. Complementary and alternative approaches to pain relief during labor. Evid Based Complement Alternat Med. 2007 Dec;4(4):409-17. doi: 10.1093/ecam/nem012.

    PMID: 18227907BACKGROUND
  • Toker E, Komurcu N. Effect of Turkish classical music on prenatal anxiety and satisfaction: A randomized controlled trial in pregnant women with pre-eclampsia. Complement Ther Med. 2017 Feb;30:1-9. doi: 10.1016/j.ctim.2016.11.005. Epub 2016 Nov 18.

    PMID: 28137517BACKGROUND
  • Bekiroglu T, Ovayolu N, Ergun Y, Ekerbicer HC. Effect of Turkish classical music on blood pressure: a randomized controlled trial in hypertensive elderly patients. Complement Ther Med. 2013 Jun;21(3):147-54. doi: 10.1016/j.ctim.2013.03.005. Epub 2013 Apr 2.

    PMID: 23642944BACKGROUND
  • Shin HS, Kim JH. Music Therapy on Anxiety, Stress and Maternal-fetal Attachment in Pregnant Women During Transvaginal Ultrasound. Asian Nurs Res (Korean Soc Nurs Sci). 2011 Mar;5(1):19-27. doi: 10.1016/S1976-1317(11)60010-8. Epub 2011 Apr 5.

    PMID: 25029946BACKGROUND
  • Laopaiboon M, Lumbiganon P, Martis R, Vatanasapt P, Somjaivong B. Music during caesarean section under regional anaesthesia for improving maternal and infant outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006914. doi: 10.1002/14651858.CD006914.pub2.

    PMID: 19370660BACKGROUND
  • Handan E, Sahiner NC, Bal MD, Dissiz M. Effects of Music during Multiple Cesarean Section Delivery. J Coll Physicians Surg Pak. 2018 Mar;28(3):247-249. doi: 10.29271/jcpsp.2018.03.247.

    PMID: 29544589BACKGROUND
  • Hepp P, Hagenbeck C, Gilles J, Wolf OT, Goertz W, Janni W, Balan P, Fleisch M, Fehm T, Schaal NK. Effects of music intervention during caesarean delivery on anxiety and stress of the mother a controlled, randomised study. BMC Pregnancy Childbirth. 2018 Nov 3;18(1):435. doi: 10.1186/s12884-018-2069-6.

    PMID: 30390639BACKGROUND
  • Moradipanah F, Mohammadi E, Mohammadil AZ. Effect of music on anxiety, stress, and depression levels in patients undergoing coronary angiography. East Mediterr Health J. 2009 May-Jun;15(3):639-47.

    PMID: 19731780BACKGROUND
  • Ferrer AJ. The effect of live music on decreasing anxiety in patients undergoing chemotherapy treatment. J Music Ther. 2007 Fall;44(3):242-55. doi: 10.1093/jmt/44.3.242.

    PMID: 17645387BACKGROUND
  • Tseng YF, Chen CH, Lee CS. Effects of listening to music on postpartum stress and anxiety levels. J Clin Nurs. 2010 Apr;19(7-8):1049-55. doi: 10.1111/j.1365-2702.2009.02998.x.

    PMID: 20492049BACKGROUND
  • Kafali H, Derbent A, Keskin E, Simavli S, Gozdemir E. Effect of maternal anxiety and music on fetal movements and fetal heart rate patterns. J Matern Fetal Neonatal Med. 2011 Mar;24(3):461-4. doi: 10.3109/14767058.2010.501122. Epub 2010 Jul 7.

    PMID: 20608798BACKGROUND
  • Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95.

    PMID: 19713801BACKGROUND
  • Vianna MN, Barbosa AP, Carvalhaes AS, Cunha AJ. Music therapy may increase breastfeeding rates among mothers of premature newborns: a randomized controlled trial. J Pediatr (Rio J). 2011 May-Jun 8;87(3):206-12. doi: 10.2223/JPED.2086. Epub 2011 Apr 1. English, Portuguese.

    PMID: 21461451BACKGROUND
  • Lai HL, Chen CJ, Peng TC, Chang FM, Hsieh ML, Huang HY, Chang SC. Randomized controlled trial of music during kangaroo care on maternal state anxiety and preterm infants' responses. Int J Nurs Stud. 2006 Feb;43(2):139-46. doi: 10.1016/j.ijnurstu.2005.04.008. Epub 2005 Jul 5.

    PMID: 15996669BACKGROUND
  • Whipple J. The effect of parent training in music and multimodal stimulation on parent-neonate interactions in the neonatal intensive care unit. J Music Ther. 2000 Winter;37(4):250-68. doi: 10.1093/jmt/37.4.250.

    PMID: 11281808BACKGROUND
  • Kimber L, McNabb M, Mc Court C, Haines A, Brocklehurst P. Massage or music for pain relief in labour: a pilot randomised placebo controlled trial. Eur J Pain. 2008 Nov;12(8):961-9. doi: 10.1016/j.ejpain.2008.01.004. Epub 2008 Mar 4.

    PMID: 18304848BACKGROUND
  • Bulfone T, Quattrin R, Zanotti R, Regattin L, Brusaferro S. Effectiveness of music therapy for anxiety reduction in women with breast cancer in chemotherapy treatment. Holist Nurs Pract. 2009 Jul-Aug;23(4):238-42. doi: 10.1097/HNP.0b013e3181aeceee.

    PMID: 19574761BACKGROUND
  • Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.

    PMID: 18395022BACKGROUND
  • Chang SC, Chen CH. Effects of music therapy on women's physiologic measures, anxiety, and satisfaction during cesarean delivery. Res Nurs Health. 2005 Dec;28(6):453-61. doi: 10.1002/nur.20102.

    PMID: 16287051BACKGROUND
  • Lin HH, Chang YC, Chou HH, Chang CP, Huang MY, Liu SJ, Tsai CH, Lei WT, Yeh TL. Effect of music interventions on anxiety during labor: a systematic review and meta-analysis of randomized controlled trials. PeerJ. 2019 May 15;7:e6945. doi: 10.7717/peerj.6945. eCollection 2019.

    PMID: 31143552BACKGROUND
  • Reza N, Ali SM, Saeed K, Abul-Qasim A, Reza TH. The impact of music on postoperative pain and anxiety following cesarean section. Middle East J Anaesthesiol. 2007 Oct;19(3):573-86.

    PMID: 18044285BACKGROUND
  • Şahin, NH. Cesarean Section: Prevalence and Consequences. Journal of Maltepe University Nursing Science and Art 2009;2:93-98.

    BACKGROUND
  • Altuntaş H., Dansuk R., Köse O. Evaluation of Cesarean Ratios in Terms of Several Variables. KÜ Tıp Fak Derg 2013;15: 1-7.

    BACKGROUND
  • Yüksel N. Anxiety disorders. In: Yüksel N, ed. Mental Disorders. 3rd ed. Ankara:MN Medikal & Nobel; 2006:143-182.

    BACKGROUND
  • Gürkan A, Bilge A. Alternative therapies and psychiatric nursing. Ege Univ JNurs High School. 2006;22:225-232.

    BACKGROUND
  • Schmidt LA, Trainor LJ. Frontal brain electrical activity (EEG) distinguishes valence and intensity of musical emotions. Cogn Emot. 2001;15:487-500.

    BACKGROUND
  • Chlan L. A review of the evidence for music intervention to manage anxiety in critically ill patients receiving mechanical ventilatory support. Arch Psychiatr Nurs. 2009 Apr;23(2):177-9. doi: 10.1016/j.apnu.2008.12.005.

    PMID: 19327560BACKGROUND
  • Wakim JH, Smith S, Guinn C. The efficacy of music therapy. J Perianesth Nurs. 2010 Aug;25(4):226-32. doi: 10.1016/j.jopan.2010.05.009.

    PMID: 20656259BACKGROUND
  • Procelli DE. The effects of music therapy and relaxation prior to breastfeeding on the anxiety of new mothers and the behavior state of their ınfants during feeding. F.S.U. College of Music, MA Thesis, Florida, United States; 2005.

    BACKGROUND
  • Mamuk R, Davas Nİ. Non-pharmacological relaxation and sensual stimulation methods used in the control of delivery pain. Med Bull Sisli Etfal Hosp. 2010;44:137-144.

    BACKGROUND
  • Ersanlı C. The effect of music listened by primigravidae treated with induction of labor through training during labor on delivery process. M.U. Health Sciences Institute, MA Thesis, Istanbul, Turkey; 2007.

    BACKGROUND
  • Çatalgöl Ş. The effect of ney sound listened by primigravidae treated with induction of labor through training during labor on delivery process. E U. Health Sciences Institute, MA Thesis, İzmir; 2013

    BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Anxiety DisordersPain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 1, 2019

Study Start

February 5, 2018

Primary Completion

July 2, 2018

Study Completion

October 26, 2018

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations