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THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION AND NEONATAL OUTCOMES

Primary Purpose

Labor Pain, Satisfaction, Infant Conditions

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Labor Dance
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.
  • Those who met the inclusion criteria (Volunteering, term pregnancy (37-41 gestational weeks), single foetus, not having any pregnancy complication (oligohydramniosis and polihydramniosis, placenta previa, pre-eclampsia, premature rupture of membrane, presentation anomalies, intrauterine growth retardation, intrauterine death, macrosomic baby, foetal distress etc.)

Exclusion Criteria:

When delivered by cesarean sectio,

  • Labor was inducted
  • Narcotic analgesics used

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

The Dance Practitioner Spouse/Partner Group

The Dance Practitioner Midwife Group

The Control Group

Arm Description

The Dance Practitioner Spouse/Partner Group (DPSG)

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

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

Outcomes

Primary Outcome Measures

Pregnant women's perceived labor pain
- A Visual Analogue Scale (VAS) was administered to determine pregnant women's perceived labor pain
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.
Apgar scores
Newborns' first-minute, fifth-minute, and tenth-minute Apgar scores were evaluated and recorded
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

Secondary Outcome Measures

Full Information

First Posted
December 4, 2019
Last Updated
December 11, 2019
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04196660
Brief Title
THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION AND NEONATAL OUTCOMES
Official Title
THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION, NEWBORN APGAR SCORE AND OXYGEN SATURATION LEVEL
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
During a labor dance, pregnant women's hands were wrapped around the neck of the partner (midwife or spouse), the pregnant woman put her head on her partner's shoulder, and they swung left to right accompanied by calming music. During the labor dance, the partner accompanied the pregnant woman's swinging movements and massaged the pregnant woman's sacral area at the same time. The study showed a positive effect of labor dancing on decreasing birth pain and improving satisfaction and neonatal outcomes whether the dance was performed with the spouse or the midwife during the intrapartum period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Satisfaction, Infant Conditions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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%).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Dance Practitioner Spouse/Partner Group
Arm Type
Experimental
Arm Description
The Dance Practitioner Spouse/Partner Group (DPSG)
Arm Title
The Dance Practitioner Midwife Group
Arm Type
Experimental
Arm Description
The Dance Practitioner Midwife Group (DPMG) included 40 pregnant women and midwives who had received labor dance training
Arm Title
The Control Group
Arm Type
No Intervention
Arm Description
The Control Group included 80 pregnant women who were subjected to routine treatment without dance
Intervention Type
Behavioral
Intervention Name(s)
Labor Dance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnant women's perceived labor pain
Description
- A Visual Analogue Scale (VAS) was administered to determine pregnant women's perceived labor pain
Time Frame
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
Title
pregnant women's satisfaction level
Description
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.
Time Frame
first hour after the delivery
Title
Apgar scores
Description
Newborns' first-minute, fifth-minute, and tenth-minute Apgar scores were evaluated and recorded
Time Frame
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.
Title
oxygen saturation levels
Description
Newborns' first-minute, fifth-minute, and tenth-minute oxygen saturation levels were measured on their right hands, and the results were recorded
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Those who met the inclusion criteria (Volunteering, term pregnancy (37-41 gestational weeks), single foetus, not having any pregnancy complication (oligohydramniosis and polihydramniosis, placenta previa, pre-eclampsia, premature rupture of membrane, presentation anomalies, intrauterine growth retardation, intrauterine death, macrosomic baby, foetal distress etc.) Exclusion Criteria: When delivered by cesarean sectio, Labor was inducted Narcotic analgesics used
Facility Information:
Facility Name
Selcuk University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) available to other researchers.
IPD Sharing Time Frame
December 2019
Citations:
PubMed Identifier
32527687
Citation
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.
Results Reference
derived

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THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION AND NEONATAL OUTCOMES

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