Pregnant WomenNCT04746170
The Effect of Labor Dance on Labor Pain, Anxiety, Birth Time and Maternal Satisfaction
A study testing Labor Dance in people with Pregnant Women, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Labor Dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Dec 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 13Show fewer
- 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.),
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Pregnant Women
- Being tested
- Labor Dance
- Keywords
- Birth, Labor Dance, Anxiety, Maternal Satisfaction, Nurse
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor DanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: within the first 4 hours postpartum
Secondary outcomes (2)
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.
Measured: within the first 4 hours postpartum
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)
Measured: During labor assessed up to 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start17 Dec 2020
- Primary completion17 Aug 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kaloglu Binici, Artvin Coruh University
- Investigators
- Dilek KALOĞLU BİNİCİ, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746170
- Sponsor's protocol ID
- Labor Dance
- Status last verified
- Jul 2023
- First submitted
- 3 Feb 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32527687Kalog 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.
PubMed 37831917
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04746170
- Acronym / sponsor ID
- Labor Dance
- Conditions
- Pregnant Women
- Keywords
- Birth, Labor Dance, Anxiety, Maternal Satisfaction, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multiparous | Experimental | Other: Labor DancePregnant 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. |
| Multiparous Control | No intervention | –Only routine practices were performed with the control group, and data were recorded as in the experimental groups. |
| Primipar | Experimental | Other: Labor DancePregnant 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. |
| Primiparous control | No intervention | –Only routine practices were performed with the control group, and data were recorded as in the experimental groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor DancePregnant 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. | Other | Multiparous, Primipar |
Primary outcome
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.
State Anxiety Scale
Time frame: During labor assessed up to 7 hours
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
Time frame: within the first 4 hours postpartum
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.
2 secondary outcomes
The Scale for Measuring Maternal Satisfaction (SMMS)-normal birth
Time frame: within the first 4 hours postpartum
Labor duration was assessed with The Postpartum Maternal Information Form (PMIF)
Time frame: During labor assessed up to 18 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 32527687Akin 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.
- Derived from this study: PubMed 37831917Kalog 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek KALOĞLU BİNİCİ principal investigator
Artvin Coruh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labor Dance in people with Pregnant Women, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: During labor assessed up to 12 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746170, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.