NCT03648099

Brief Summary

The study was conducted to investigate the effect of labor dance and music used during the active phase of labor on labor pain and fear of childbirth. The study was designed as a single-blind randomized controlled intervention trial. The participants included in sample are taken into 3 groups (totally 93 participants). A total of 93 individuals, 31 of whom were in the dance group (D), 30 in the music group (M), and 32 in the control group (C), were included in the survey. Data were collected between 15 February 2018 and 15 June 2018 by means of a Personal Information Form, the Labor Monitoring Form, the Visual Analogue Scale (VAS), and version A of the Wijma Delivery Expectancy Questionnaire (W-DEQA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

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 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 17, 2018

Last Update Submit

August 23, 2018

Conditions

Keywords

Labor PainLabor danceMusicFear of childbirth

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale Score,

    The perceived pain pregnant women in groups were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). Assessed the labor pain level with Visual Analogue Scale score. This is a 10 cm scale which is labeled "no pain" at one end and "severe pain" at the other end. (0=no pain; 10= pain as bad as can be). Increasing scores indicate women's labor pain.

    Baseline

Secondary Outcomes (3)

  • Version A of the Wijma Delivery Expectancy Questionnaire Score

    Baseline

  • Recurrence of Fear of Childbirth

    30 minutes, 60 minutes and 90 minutes

  • Recurrence of perceived pain

    30 minutes, 60 minutes and 90 minutes

Study Arms (2)

Labor Dance and music groups

EXPERIMENTAL

1. Labor Dance; The pregnant women performed labor dance when the cervical dilatation reached 4-5 cm. The dance was performed in the company of music played through headphones. 2. The pregnant women listened to music for 30 minutes when the cervical dilatation reached 4-5 cm. They took any position they wanted while listening to music.

Behavioral: Labor danceBehavioral: Music

Control group

NO INTERVENTION

The control group: No intervention was made to relieve the labor pain and reduce the fear of childbirth in the control group of the study. They were administered routine hospital applications.

Interventions

Labor danceBEHAVIORAL

The dance group which involved pregnant women who performed the labor dance

Labor Dance and music groups
MusicBEHAVIORAL

The music group involving pregnant women who were exposed to music.

Labor Dance and music groups

Eligibility Criteria

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

You may qualify if:

  • An indication for vaginal delivery
  • Primipara
  • Cervical dilatation of 3 cm or over
  • Full-term pregnancy (38-42 gestational weeks)
  • Single healthy fetus in vertex position
  • No complication that can cause dystocia in labor (such as contraction anomalies, birth object, birth canal associated dystocia, maternal psychology associated dystocia)
  • Not using analgesia and anesthesia during the first phase of the labor
  • Having no physical disability to dance
  • Having no difficulty to take upright position and move
  • Having no communication problem.

You may not qualify if:

  • Giving up participating in the study
  • Abnormal changes in fetal heartbeat
  • Emergence of an unexpected complication in the pregnant woman or the fetus 4) Taking analgesics and anesthesia
  • \) Incomplete intervention and follow-up due to rapid labor 6) Being taken to C/S before the completion of the intervention and follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Altındağ, Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (7)

  • Abdul-Sattar Khudhur Ali S, Mirkhan Ahmed H. Effect of Change in Position and Back Massage on Pain Perception during First Stage of Labor. Pain Manag Nurs. 2018 Jun;19(3):288-294. doi: 10.1016/j.pmn.2018.01.006. Epub 2018 Apr 19.

    PMID: 29680213BACKGROUND
  • Whitburn LY, Jones LE, Davey MA, Small R. Women's experiences of labour pain and the role of the mind: an exploratory study. Midwifery. 2014 Sep;30(9):1029-35. doi: 10.1016/j.midw.2014.04.005. Epub 2014 Apr 30.

  • Simavli S, Kaygusuz I, Gumus I, Usluogullari B, Yildirim M, Kafali H. Effect of music therapy during vaginal delivery on postpartum pain relief and mental health. J Affect Disord. 2014 Mar;156:194-9. doi: 10.1016/j.jad.2013.12.027. Epub 2013 Dec 28.

  • Masoudi Z, Akbarzadeh M, Vaziri F, Zare N, Ramzi M. The effects of decreasing maternal anxiety on fetal oxygenation and nucleated red blood cells count in the cord blood. Iran J Pediatr. 2014 Jun;24(3):285-92.

  • Gokyildiz Surucu S, Ozturk M, Avcibay Vurgec B, Alan S, Akbas M. The effect of music on pain and anxiety of women during labour on first time pregnancy: A study from Turkey. Complement Ther Clin Pract. 2018 Feb;30:96-102. doi: 10.1016/j.ctcp.2017.12.015. Epub 2017 Dec 19.

  • Abdolahian S, Ghavi F, Abdollahifard S, Sheikhan F. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study. Glob J Health Sci. 2014 Mar 30;6(3):219-26. doi: 10.5539/gjhs.v6n3p219.

  • O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.

MeSH Terms

Conditions

Labor Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

PainNeurologic 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
SINGLE
Who Masked
CARE PROVIDER
Masking Details
In order to avoid bias in assessing pain and fear, three midwives who were not involved in the study team, who worked in the hospital where the study was carried out and who did not know the groups of the participants administered the scales. The midwives who were involved in data collection during the study were trained by the researchers on the use of data collection tools.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: a single-blind randomized controlled intervention trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 27, 2018

Study Start

February 15, 2018

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations