NCT04196660

Brief Summary

Objective: This research was conducted to determine the effects of labor dance on perceived birth pain, birth satisfaction, and neonatal outcomes. Design: This research was an experimental study with three groups. The data were collected during the active phase of labor as three groups; Dance Practitioner Midwife Group (DPMG-40 pregnant), Dancing Practitioner Spouse / Partner Group (DPSG-40 pregnant) and Control Group (CG-80 pregnant). Setting: This research was conducted at Ministry of Health Izmir Urla State Hospital between April 1, 2017 and October 31, 2017. Participants: The pregnant women in the DPMG danced with the midwives in charge of the delivery room and following the pregnancy, but those in the DPSG danced with their spouse/partners during the active phase of labor. Labor pains were measured before the labor dance was begun (when the vaginal dilatation was 4 cm) and after the labor dance (when the vaginal dilatation was 9 cm) using a Visual Analogue Scale (VAS). In the postpartum period, the first, fifth, and tenth-minute Apgar scores and oxygen saturation levels of the newborns were measured and recorded. The Mackey Childbirth Satisfaction Rating Scale was applied to evaluate the women's birth satisfaction at the end of the first hour. In the Control Group, only routine practices were implemented in the hospital, and data were collected as indicated in the experimental groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

December 4, 2019

Last Update Submit

December 11, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pregnant women's perceived labor pain

    \- A Visual Analogue Scale (VAS) was administered to determine pregnant women's perceived labor pain

    The perceived pain pregnant women in groups were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). This is a 10 cm scale which is labeled "no pain" a

  • pregnant women's satisfaction level

    The Mackey Childbirth Satisfaction Rating Scale was administered in the first hour after .the delivery to determine pregnant women's satisfaction level.The Mackey Childbirth. Satisfaction Rating Scale was administered in the first hour after the delivery to determine pregnant women's satisfaction level.Fives likert type consists of 34 items and six sub-dimensions. Bottom dimensions self satisfaction, partner involvement, infant, midwife / nurses, doctors and general satisfaction related questions. The minimum score that can be obtained from the scale is 34 and the highest score is 170. The higher the score obtained from the scale, the higher the satisfaction level of women.

    first hour after the delivery

  • Apgar scores

    Newborns' first-minute, fifth-minute, and tenth-minute Apgar scores were evaluated and recorded

    neonatal apgar score was evaluated at the 1st, 5th and 10th minutes after birth. The aim of this study was to evaluate the effects of birth dance on the newborn.

  • oxygen saturation levels

    Newborns' first-minute, fifth-minute, and tenth-minute oxygen saturation levels were measured on their right hands, and the results were recorded

    neonatal oxygen saturation level was evaluated at the 1st, 5th and 10th minutes after birth. The aim of this study was to evaluate the effects of birth dance on the newborn.

Study Arms (3)

The Dance Practitioner Spouse/Partner Group

EXPERIMENTAL

The Dance Practitioner Spouse/Partner Group (DPSG)

Behavioral: Labor Dance

The Dance Practitioner Midwife Group

EXPERIMENTAL

The Dance Practitioner Midwife Group (DPMG) included 40 pregnant women and midwives who had received labor dance training

Behavioral: Labor Dance

The Control Group

NO INTERVENTION

The Control Group included 80 pregnant women who were subjected to routine treatment without dance

Interventions

Labor DanceBEHAVIORAL

The pregnant women and their spouses were trained about the labor dance in the prenatal training without disclosing any information regarding the delivery and labor pain. The pregnant women and their spouses/partners who wanted to perform the practice were asked to inform the researcher when the labor started. The researcher stayed with the pregnant women and their spouses during the practice and labor process. The pregnant women started to dance with their spouses during the active phase of the labor process accompanied by meditation music (on a YouTube channel named Ohgertam Jugrefem) in a dim, silent environment. The spouse or partner massaged the pregnant woman's sacral area while dancing. During the active phase of labor, the pregnant women in the DPMG danced with the midwives who were attendant in the delivery room and who were monitoring the pregnant women's status.

The Dance Practitioner Midwife GroupThe Dance Practitioner Spouse/Partner Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those who were admitted to the Ministry of Health Urla State Hospital for labor
  • Those whose cervical dilatation between 4 and 8 cm.
  • Those who had received labor dance training by attending Prenatal Training with their spouses/partners in perinatal period.

You may not qualify if:

  • When delivered by cesarean sectio,
  • Labor was inducted
  • Narcotic analgesics used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Labor PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study sample included 160 pregnant women who had the following characteristics: i) those who were admitted to the Ministry of Health Urla State Hospital for labor ii) those who met the inclusion criteria, and iii) those who had received labor dance training by attending Prenatal Training with their spouses/partners in the prenatal period. The Dance Practitioner Spouse/Partner Group (DPSG) (Experimental) included 40 pregnant women who signed the Informed Consent Form, the Dance Practitioner Midwife Group (DPMG) included 40 pregnant women and midwives who had received labor dance training, and the Control Group included 80 pregnant women who were subjected to routine treatment without dance. The sample size was calculated using a power analysis. The optimum sample size was found to be 160 as Type 1 error α = 0.05 and Type 2 error β = 0.2 (power = 80%).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Prof. Dr.

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 12, 2019

Study Start

April 15, 2017

Primary Completion

October 15, 2017

Study Completion

October 30, 2017

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) available to other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
December 2019

Locations