Labor PainlabordanceNCT04287699
The Effect of Labor Dance on Traumatic Birth Perception and Comfort
A study testing labor dance in people with Labor Pain and Fear of Childbirth, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
ne of the non-pharmacological methods that provide opportunities such as massage and freedom of movement with the support of the spouse / partner is the birth dance. In order to reduce the pain perceived by the woman and provide emotional support, the birth dance is started in the active phase of the first phase of… 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, Fear of Childbirth
- What is being tested?
- labor dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2019to 15 Mar 2020
- 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 Hospital for labor
- Those whose cervical dilatation between 4 and 8 cm.
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
ne of the non-pharmacological methods that provide opportunities such as massage and freedom of movement with the support of the spouse / partner is the birth dance.
In order to reduce the pain perceived by the woman and provide emotional support, the birth dance is started in the active phase of the first phase of the labor and continues until the end of the first phase. The woman is given the opportunity to act rhythmically with a relaxing light music with someone she prefers (spouse / partner, mother, midwife, etc.). The hands of the pregnant woman dance in the form of swinging from left to right, on the shoulder of his wife, with music; The partner is massaged by the sacrum area. It is aimed to increase the effectiveness of the method applied by adding spouse / partner support, upright posture and massage in addition to the music and body movements that dance includes, and also to provide emotional support to the woman. In this study, it was aimed to evaluate the effect of birth dance on traumatic birth perception and comfort.
Read the detailed description
The study was planned as randomized controlled. Pregnant women and their accompanying persons assigned to the study group will be informed about working in the tram room where the pregnant woman is before the active phase begins 'Using the Labor Dance Practice Guide (Annex 3) and cervical dilatation 4 cm. they will be asked to practice in accordance with this guide. Details of the application (such as dance time, rest time) will be recorded in the 'Labor Dance Control Guide' (Annex 4) by the researcher. Pregnant women will be followed by the doctor and midwife responsible for the pregnancy during the tram, and the researcher will not be involved in tram follow-up of the pregnant woman (cervical dilation, pediatric heart sound, contraction follow-up, vital signs of the pregnant woman).
- Conditions
- Labor Pain, Fear of Childbirth
- Being tested
- labor dance
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labor danceOther
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 in a dim, silent environment. The spouse or partner massaged the pregnant woman's sacral area while dancing.
| Study group | Role | What they receive |
|---|---|---|
| labor dance group | Experimental | 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 in a dim, silent environment.The pregnant women started to dance with their spouses during the active phase of the labor process accompanied by meditation music in a dim, silent environment. The spouse or partner massaged the pregnant woman's sacral area while dancing. Receives: Other: labor dance |
| Control group | 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.
Childbirth Comfort Questionnaire
The scale is a five-point Likert type scale with 14 items. In the original of the scale, it is stated that each item can be scored between 1-5 (1 = Strongly disagree, 2 = Mostly disagree, 3 = Partially agree, 4 = Mostly agree, 5 = I totally agree). The minimum score that can be obtained from the scale is 14 and the highest score is 70. The higher the score, the higher the comfort, the lower the lower comfort.
Measured: ten minute after labor dance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start15 May 2019
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as randomized controlled. Pregnant women and their accompanying persons assigned to the study group will be informed about working in the tram room where the pregnant woman is before the active phase begins 'Using the Birth Dance Practice Guide (Annex 3) and cervical dilatation 4 cm. they will be asked to practice in accordance with this guide. Details of the application (such as dance time, rest time) will be recorded in the 'Birth Dance Control Guide' (Annex 4) by the researcher. Pregnant women will be followed by the doctor and midwife responsible for the pregnancy during the tram, and the researcher will not be involved in tram follow-up of the pregnant woman (cervical dilation, pediatric heart sound, contraction follow-up, vital signs of the pregnant woman).
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
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
- NCT04287699
- Sponsor's protocol ID
- Labor Dance
- Acronym
- labordance
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Labor Dance on Traumatic Birth Perception and Comfort
- ClinicalTrials.gov ID
- NCT04287699
- Acronym / sponsor ID
- labordance / Labor Dance
- Conditions
- Labor Pain, Fear of Childbirth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 27 Feb 2020 (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.
ne of the non-pharmacological methods that provide opportunities such as massage and freedom of movement with the support of the spouse / partner is the birth dance.
In order to reduce the pain perceived by the woman and provide emotional support, the birth dance is started in the active phase of the first phase of the labor and continues until the end of the first phase. The woman is given the opportunity to act rhythmically with a relaxing light music with someone she prefers (spouse / partner, mother, midwife, etc.). The hands of the pregnant woman dance in the form of swinging from left to right, on the shoulder of his wife, with music; The partner is massaged by the sacrum area. It is aimed to increase the effectiveness of the method applied by adding spouse / partner support, upright posture and massage in addition to the music and body movements that dance includes, and also to provide emotional support to the woman. In this study, it was aimed to evaluate the effect of birth dance on traumatic birth perception and comfort.
Detailed description
The study was planned as randomized controlled. Pregnant women and their accompanying persons assigned to the study group will be informed about working in the tram room where the pregnant woman is before the active phase begins 'Using the Labor Dance Practice Guide (Annex 3) and cervical dilatation 4 cm. they will be asked to practice in accordance with this guide. Details of the application (such as dance time, rest time) will be recorded in the 'Labor Dance Control Guide' (Annex 4) by the researcher. Pregnant women will be followed by the doctor and midwife responsible for the pregnancy during the tram, and the researcher will not be involved in tram follow-up of the pregnant woman (cervical dilation, pediatric heart sound, contraction follow-up, vital signs of the pregnant woman).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was planned as randomized controlled. Pregnant women and their accompanying persons assigned to the study group will be informed about working in the tram room where the pregnant woman is before the active phase begins 'Using the Birth Dance Practice Guide (Annex 3) and cervical dilatation 4 cm. they will be asked to practice in accordance with this guide. Details of the application (such as dance time, rest time) will be recorded in the 'Birth Dance Control Guide' (Annex 4) by the researcher. Pregnant women will be followed by the doctor and midwife responsible for the pregnancy during the tram, and the researcher will not be involved in tram follow-up of the pregnant woman (cervical dilation, pediatric heart sound, contraction follow-up, vital signs of the pregnant woman).
| Arm | Type | Receives |
|---|---|---|
| labor dance group | Experimental | Other: labor danceThe 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 in a dim, silent environment.The pregnant women started to dance with their spouses during the active phase of the labor process accompanied by meditation music in a dim, silent environment. The spouse or partner massaged the pregnant woman's sacral area while dancing. |
| Control group | 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 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Those who were admitted to Hospital for labor
- Those whose cervical dilatation between 4 and 8 cm.
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/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 in a dim, silent environment. The spouse or partner massaged the pregnant woman's sacral area while dancing. | Other | labor dance group |
Primary outcome
Childbirth Comfort Questionnaire
Time frame: ten minute after labor dance
The scale is a five-point Likert type scale with 14 items. In the original of the scale, it is stated that each item can be scored between 1-5 (1 = Strongly disagree, 2 = Mostly disagree, 3 = Partially agree, 4 = Mostly agree, 5 = I totally agree). The minimum score that can be obtained from the scale is 14 and the highest score is 70. The higher the score, the higher the comfort, the lower the lower comfort.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- 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.
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 Fear of Childbirth, 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 2 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: status not confirmed, as of the sponsor's last update on 27 Feb 2020. 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?
Results are not available in the source record.
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?
Childbirth Comfort Questionnaire (time frame: ten minute after labor dance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2020.