search
Back to results

The Effect of Labor Dance on Labor Pain, Anxiety, Birth Time and Maternal Satisfaction

Primary Purpose

Pregnant Women

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

About this trial

This is an interventional supportive care trial for Pregnant Women focused on measuring Birth, Labor Dance, Anxiety, Maternal Satisfaction, Nurse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Not being pregnant diagnosed with Covid -19 (last 20 days)
  • Accepting to be included in research,
  • Being over the age of 18,
  • 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.),

Exclusion Criteria:

  • 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).

Sites / Locations

  • Artvin State Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Multiparous

Multiparous Control

Primipar

Primiparous control

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

The Scale for Measuring Maternal Satisfaction (SMMS)-normal birth
The scale consists of 43 and 10 sub-dimensions. The sub dimensions of the scale; perception of the healthcare team, midwifery-nursing care in labor, relief, participation in decisions and information, respect for privacy, meeting expectations, meeting the baby, postpartum care, hospital room and hospital facilities. The items of the scale are scored on a 5-point Likert-type scale according to whether they agree with the statements or not. The answers given by the items (1-2-3-4-5 / Disagree-Partially Agree-Undecided-Agree-Strongly Agree) are scored on a five-point Likert-type scale depending on whether the items agree with the statements or not. The total raw score is the lowest 43 and the highest 215. As the total score obtained from the scale increases, the level of satisfaction of mothers with the care they receive in the hospital during normal delivery increases.
Labor duration was assessed with The Postpartum Maternal Information Form (PMIF)
The Postpartum Maternal Information Form (PMIF) was prepared by the researchers using the relevant literature. It consists of questions regarding information about birth (duration of labor, oxytocin, and episotomy practices at birth)

Full Information

First Posted
February 3, 2021
Last Updated
July 9, 2023
Sponsor
Artvin Coruh University
search

1. Study Identification

Unique Protocol Identification Number
NCT04746170
Brief Title
The Effect of Labor Dance on Labor Pain, Anxiety, Birth Time and Maternal Satisfaction
Official Title
The Effect of Labor Dance Applied to Pregnant Women in the First Stage of Labor on Labor Pain, Anxiety, Birth Time and Maternal Satisfaction at Birth: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Artvin Coruh 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
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.
Detailed Description
The study was planned in randomized controlled experimental type. The pregnant women will be followed in single rooms. The information about how to apply the labor dance to the pregnant women in the experimental group will be explained by the researcher in the latent phase of birth and will be shown practically. Pregnant women in the experimental group will be given labor dance with music every hour until the cervical opening starts from 3 cm (latent phase) and the cervical opening reaches 8 cm. Pregnant women will musically choose one of Acemaşiran Authority, Rehavi Authority and Farid Farjad's Thin Rose of My Idea. The researcher and pregnant women will perform a labor dance with the music for 15 minutes per hour. The researcher and the pregnant will hold each other's hands (3-4 steps distance), stand opposite each other and perform pelvic tilt together. When the pregnant woman desires or has contractions, the researcher will massage the waist and sacrum area with a ball massage glove. Details of the application and birth (such as dance time, birth time, contractions) will be recorded by the researcher. Pregnant women will be followed by the doctor, midwife and researcher during the tram, birth and first four hours postpartum. Ball Massage Glove Used in Mechanical Massage Application It consists of nine metal balls with a diameter of 1.5 cm that can rotate 360 degrees. With its glove design and ergonomic structure, it can be easily applied to any area. By concentrating directly on the massage points, it can be used more effectively on all points of the body. Since it is made of silicone material, it does not harm the hand and the area to be massaged while massaging. (Information taken from introductory guide).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women
Keywords
Birth, Labor Dance, Anxiety, Maternal Satisfaction, Nurse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
In RCT, blinding will be done in terms of participants and statistics.
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiparous
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiparous Control
Arm Type
No Intervention
Arm Description
Only routine practices were performed with the control group, and data were recorded as in the experimental groups.
Arm Title
Primipar
Arm Type
Experimental
Arm Description
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.
Arm Title
Primiparous control
Arm Type
No Intervention
Arm Description
Only routine practices were performed with the control group, and data were recorded as in the experimental groups.
Intervention Type
Other
Intervention Name(s)
Labor Dance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
During labor assessed up to 12 hours
Title
State Anxiety Scale
Description
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.
Time Frame
During labor assessed up to 7 hours
Title
State Anxiety Scale
Description
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.
Time Frame
within the first 4 hours postpartum
Secondary Outcome Measure Information:
Title
The Scale for Measuring Maternal Satisfaction (SMMS)-normal birth
Description
The scale consists of 43 and 10 sub-dimensions. The sub dimensions of the scale; perception of the healthcare team, midwifery-nursing care in labor, relief, participation in decisions and information, respect for privacy, meeting expectations, meeting the baby, postpartum care, hospital room and hospital facilities. The items of the scale are scored on a 5-point Likert-type scale according to whether they agree with the statements or not. The answers given by the items (1-2-3-4-5 / Disagree-Partially Agree-Undecided-Agree-Strongly Agree) are scored on a five-point Likert-type scale depending on whether the items agree with the statements or not. The total raw score is the lowest 43 and the highest 215. As the total score obtained from the scale increases, the level of satisfaction of mothers with the care they receive in the hospital during normal delivery increases.
Time Frame
within the first 4 hours postpartum
Title
Labor duration was assessed with The Postpartum Maternal Information Form (PMIF)
Description
The Postpartum Maternal Information Form (PMIF) was prepared by the researchers using the relevant literature. It consists of questions regarding information about birth (duration of labor, oxytocin, and episotomy practices at birth)
Time Frame
During labor assessed up to 18 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Not being pregnant diagnosed with Covid -19 (last 20 days) Accepting to be included in research, 20 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.), Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek KALOĞLU BİNİCİ
Organizational Affiliation
Artvin Coruh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artvin State Hospital
City
Artvin
ZIP/Postal Code
08000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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
background

Learn more about this trial

The Effect of Labor Dance on Labor Pain, Anxiety, Birth Time and Maternal Satisfaction

We'll reach out to this number within 24 hrs