Labor PainNCT04196660
THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION AND NEONATAL OUTCOMES
A study testing Labor Dance in people with Labor Pain and Satisfaction, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Satisfaction, Infant Conditions
- What is being tested?
- Labor Dance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2017to 30 Oct 2017
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
Who cannot join
- When delivered by cesarean sectio,
- Labor was inducted
- Narcotic analgesics used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION, NEWBORN APGAR SCORE AND OXYGEN SATURATION LEVEL
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).
Read more
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.
Read the 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.
- Conditions
- Labor Pain, Satisfaction, Infant Conditions
- Being tested
- Labor Dance
- Medical subject headings
- Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor DanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The Dance Practitioner Spouse/Partner Group | Experimental | The Dance Practitioner Spouse/Partner Group (DPSG) Receives: 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 Receives: Behavioral: Labor Dance |
| The Control Group | No intervention | The Control Group included 80 pregnant women who were subjected to routine treatment without dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnant women's perceived labor pain
- A Visual Analogue Scale (VAS) was administered to determine pregnant women's perceived labor pain
Measured: 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.
Measured: first hour after the delivery
Apgar scores
Newborns' first-minute, fifth-minute, and tenth-minute Apgar scores were evaluated and recorded
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start15 Apr 2017
- Primary completion15 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Akın, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196660
- Sponsor's protocol ID
- 24.03.17/ 17-3/8
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) available to other researchers.
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 32527687
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION, NEWBORN APGAR SCORE AND OXYGEN SATURATION LEVEL
- ClinicalTrials.gov ID
- NCT04196660
- Acronym / sponsor ID
- 24.03.17/ 17-3/8
- Conditions
- Labor Pain, Satisfaction, Infant Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 12 Dec 2019 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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%).
| Arm | Type | Receives |
|---|---|---|
| The Dance Practitioner Spouse/Partner Group | Experimental | Behavioral: Labor DanceThe Dance Practitioner Spouse/Partner Group (DPSG) |
| The Dance Practitioner Midwife Group | Experimental | Behavioral: Labor DanceThe Dance Practitioner Midwife Group (DPMG) included 40 pregnant women and midwives who had received labor dance training |
| The Control Group | No intervention | –The Control Group included 80 pregnant women who were subjected to routine treatment without dance |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (3 listed)
- When delivered by cesarean sectio,
- Labor was inducted
- Narcotic analgesics used
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 DanceThe 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. | Behavioural | The Dance Practitioner Midwife Group, The Dance Practitioner Spouse/Partner Group |
Primary outcome
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
- A Visual Analogue Scale (VAS) was administered to determine pregnant women's perceived labor pain
pregnant women's satisfaction level
Time frame: first hour after the delivery
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
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.
Newborns' first-minute, fifth-minute, and tenth-minute Apgar scores were evaluated and recorded
oxygen saturation levels
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.
Newborns' first-minute, fifth-minute, and tenth-minute oxygen saturation levels were measured on their right hands, and the results were recorded
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 12 Dec 2019.
- Derived from this study: 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Labor Pain and Satisfaction, run by Selcuk 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 4 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 12 Dec 2019. 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?
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). The study lists 4 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 NCT04196660, which also lists 1 linked publication.
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 12 Dec 2019.