- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746170
The Effect of Labor Dance on Labor Pain, Anxiety, Birth Time and Maternal Satisfaction
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 Overview
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Artvin, Turkey, 08000
- Artvin State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multiparous
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.
|
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.
|
|
No Intervention: Multiparous Control
Only routine practices were performed with the control group, and data were recorded as in the experimental groups.
|
|
|
Experimental: Primipar
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.
|
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.
|
|
No Intervention: Primiparous control
Only routine practices were performed with the control group, and data were recorded as in the experimental groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: During labor assessed up to 12 hours
|
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.
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During labor assessed up to 12 hours
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State Anxiety Scale
Time Frame: During labor assessed up to 7 hours
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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.
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During labor assessed up to 7 hours
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State Anxiety Scale
Time Frame: within the first 4 hours postpartum
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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.
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within the first 4 hours postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Scale for Measuring Maternal Satisfaction (SMMS)-normal birth
Time Frame: within the first 4 hours postpartum
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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.
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within the first 4 hours postpartum
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Labor duration was assessed with The Postpartum Maternal Information Form (PMIF)
Time Frame: During labor assessed up to 18 hours
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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)
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During labor assessed up to 18 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilek KALOĞLU BİNİCİ, Artvin Çoruh University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Labor Dance
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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