NCT04746170

Brief Summary

Pregnant women who are in the process of labor need physical and emotional support of health professionals in issues such as coping with labor pain, relieving fear and anxiety, and experiencing positive birth. The fact that labor dance includes components such as upright posture, pelvic movement, touch, massage provides both physical and emotional support to the pregnant woman. The aim of the study is to examine the effect of labor dance applied to pregnant women in the first stage of birth on labor pain, anxiety, birth time and maternal satisfaction at birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

February 3, 2021

Last Update Submit

July 9, 2023

Conditions

Keywords

BirthLabor DanceAnxietyMaternal SatisfactionNurse

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale (VAS)

    VAS is used to measure perceived pain. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on lower end (no pain) and on upper end (extreme pain). The pregnant women is asked to mark their current pain level on the line.

    During labor assessed up to 12 hours

  • State Anxiety Scale

    The scale consists of 20 items. The emotions or behaviors expressed in the articles are according to the degree of feeling the situation in which the individual is; It is answered by marking one of the options such as (1) none, (2) a little, (3) much, (4) completely. The total score obtained from the scale is between a minimum of 20 and a maximum of 80. The last value obtained is the individual's anxiety score.

    During labor assessed up to 7 hours

  • State Anxiety Scale

    The scale consists of 20 items. The emotions or behaviors expressed in the articles are according to the degree of feeling the situation in which the individual is; It is answered by marking one of the options such as (1) none, (2) a little, (3) much, (4) completely. The total score obtained from the scale is between a minimum of 20 and a maximum of 80. The last value obtained is the individual's anxiety score.

    within the first 4 hours postpartum

Secondary Outcomes (2)

  • The Scale for Measuring Maternal Satisfaction (SMMS)-normal birth

    within the first 4 hours postpartum

  • Labor duration was assessed with The Postpartum Maternal Information Form (PMIF)

    During labor assessed up to 18 hours

Study Arms (4)

Multiparous

EXPERIMENTAL

Pregnant women in the experimental group will be given a labor dance with music for 15 minutes per hour until the cervical opening starts from 3 cm (latent phase) and the cervical opening reaches 8 cm. The massage application will be made by the researcher to their waist and sacrum area with a ball massage glove.

Other: Labor Dance

Multiparous Control

NO INTERVENTION

Only routine practices were performed with the control group, and data were recorded as in the experimental groups.

Primipar

EXPERIMENTAL

Pregnant women in the experimental group will be given a labor dance with music for 15 minutes per hour until the cervical opening starts from 3 cm (latent phase) and the cervical opening reaches 8 cm. The massage application will be made by the researcher to their waist and sacrum area with a ball massage glove.

Other: Labor Dance

Primiparous control

NO INTERVENTION

Only routine practices were performed with the control group, and data were recorded as in the experimental groups.

Interventions

Pregnant women in the experimental group will be given a birth dance with music for 15 minutes per hour until the cervical opening starts from 3 cm (latent phase) and the cervical opening reaches 8 cm. The massage application will be made by the researcher to their waist and sacrum area with a ball massage glove.

MultiparousPrimipar

Eligibility Criteria

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

You may qualify if:

  • Not being pregnant diagnosed with Covid -19 (last 20 days)
  • Accepting to be included in research,
  • years of age,
  • Speak Turkish,
  • At least a primary school graduate,
  • No disability such as hearing or vision,
  • Having a pregnancy at term (those between 38-41 weeks of gestation),
  • Pregnant women whose labor has started actively,
  • Applying to the delivery room for vaginal delivery in the latent phase of labor (when the cervical opening is 1-3 cm),
  • Pregnant women without uterine contraction anomaly,
  • Having a single fetus, The leading part of the fetus is the head coming (in the vertex position),
  • Fetus weight 2500-4000 gr,
  • Being in the low risk pregnant group (Absence of conditions such as placenta previa, preeclampsia, heart, gestational diabetes, intrauterine growth retardation, intrauterine dead fetus, macrosomic babies, fetal distress etc.),

You may not qualify if:

  • Pregnant women whose previous birth type was cesarean section (pregnant women who preferred vaginal delivery after cesarean section)
  • Pregnant women who received epidural analgesia,
  • Pregnant women whose labor lasted less than 3 hours (rapid birth story).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artvin State Hospital

Artvin, 08000, Turkey (Türkiye)

Location

Related Publications (2)

  • Akin B, Saydam BK. The effect of labor dance on perceived labor pain, birth satisfaction, and neonatal outcomes. Explore (NY). 2020 Sep-Oct;16(5):310-317. doi: 10.1016/j.explore.2020.05.017. Epub 2020 May 30.

    PMID: 32527687BACKGROUND
  • Kalog Lu Binici D, Aktas S. The Effect of Labor Dance in the First Stage of Labor on Labor Pain, Anxiety, Duration of Labor, and Maternal Satisfaction with Labor: A Randomized Controlled Study. J Integr Complement Med. 2024 Apr;30(4):383-393. doi: 10.1089/jicm.2022.0818. Epub 2023 Oct 13.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Dilek KALOĞLU BİNİCİ

    Artvin Coruh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In RCT, blinding will be done in terms of participants and statistics.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was planned as a randomized controlled trial. The pregnant will be followed in single rooms. Pregnant women in the experimental group will be given labor dance with music for 15 minutes per hour until the cervical opening starts from 3 cm (latent phase) and the cervical opening reaches 8 cm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 9, 2021

Study Start

December 17, 2020

Primary Completion

August 17, 2021

Study Completion

March 1, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations