Labor PainNCT06229808
The Effect of the Multifunctional Birthing Ball on Labor Pain
A study testing Multifunctional Birthing ball in people with Labor Pain, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
Objective: By using the newly designed multifunctional birthing ball, it is aimed to reduce the intense perineal and sacral pain in the first and second stages of labor, to prevent perineal tears, pain and episiotomy opening with perineal heating, to take advantage of the positive effects of the birthing ball on the… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Multifunctional Birthing ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 2 Jan 2022to 29 Dec 2023
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- First-time mothers
- At term (37-42 weeks of gestation)
- Single fetal gestation
- Cervical dilatation of 3 cm or greater
- Expected spontaneous delivery
- No pregnancy complications or systemic diseases
- Age between 18 and 35 years
Who cannot join
- Non-pregnancy related chronic illness
- Pregnancy-related illness
- Pregnancy complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Design; Investigation of the Effect of Multifunctional Birthing Ball on Perineal and Sacral Pain and Duration of Labor in the First Two Stages of Labor
Objective: By using the newly designed multifunctional birthing ball, it is aimed to reduce the intense perineal and sacral pain in the first and second stages of labor, to prevent perineal tears, pain and episiotomy opening with perineal heating, to take advantage of the positive effects of the birthing ball on the pelvis to support active labor and shorten the duration of labor, and to increase the satisfaction of mothers with labor by reducing anxiety and pain.
Materials and Methods: The multifunctional birthing ball will support the active movements of the pregnant woman, as well as warming the perineum while providing lumbar and back massage. The multifunctional birthing ball was developed by researchers and manufactured by the Near East University 3D Lab. The bottom of the ball is made of flexible and explosion-proof material filled with air. The purpose of the ball is to enable the pregnant woman to make swinging and bouncing movements during active labor. The massager and heating pad will be controlled by a single electronic circuit. Three different massage modes can be selected: continuous, intermittent and fluctuating. The heating pad can be turned on and off with a single button and the temperature can be adjusted (decrease-increase). To prevent overheating and tissue damage, a maximum temperature of 42 °C was fixed on the control. The inner padding is made of a material that protects both the massager and the heating pad from external factors and also serves as a seat. The shape of the device is designed to ensure that the massager is in full contact with the waist when the pregnant woman sits on the ball. The coating of the massage chair and heating pad is made of cleanable material suitable for hospital use.
Read the detailed description
This study was designed to experimentally investigate the effect of a multifunctional birthing ball on perineal pain, sacral pain, total duration of labor, perineal tears, and women's satisfaction with the birth experience during the first and second stages of labor in pregnant women who will deliver vaginally. Pregnant women to be included in the experimental and control groups should meet the following criteria:
- First-time mothers
- At term (37-42 weeks of gestation)
- Single fetal gestation
- Cervical dilatation of 3 cm or greater
- Expected spontaneous delivery
- No pregnancy complications or systemic diseases
- No history of cephalopelvic disproportion, placenta previa, placental abruption, or fetal distress
- Willingness to participate in the study
- Age between 18 and 35 years
Experimental Intervention Participants in the experimental group will receive massages using a multifunctional birthing ball during the first stage of labor. Massages will be administered for 30 minutes each at the end of the latent, active, and transition phases (cervical dilatation 3-4 cm, 5-7 cm, and 8-10 cm, respectively). Visual Analog Scale (VAS) scores will be evaluated three times in each phase to assess low back pain. In the control group, VAS scores will be evaluated three times without massage application for the same periods.
Perineal Heating Application
Perineal heating application will be initiated when the second stage of labor begins and will continue until delivery. The heating application will consist of 20 minutes of application followed by 20 minutes of tissue rest. VAS scores will be evaluated two times during these stages to determine perineal pain. In the control group, VAS scores will be evaluated twice without heating application for the same periods.
Postpartum Evaluation
During the postpartum period, each participant will complete a 30-question "Postpartum Interview Form" that will address questions related to the status of perineal integrity at the end of labor, overall childbirth experience, and satisfaction with the birth process. Additionally, each participant will complete the "Birth Satisfaction Scale" - a 30-item questionnaire designed to assess the woman's satisfaction with her birth experience.
- Conditions
- Labor Pain
- Being tested
- Multifunctional Birthing ball
- Keywords
- Labor Pain, Birth Ball, Active Delivery, Massage, Perineal Warming
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifunctional Birthing ballDevice
In order to reduce low back pain in labor, massages will be applied to the experimental group in the first stage of labor for 30 minutes each at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm), respectively.
Perineal heating application is planned to be performed at least twice until the delivery occurs as 20 minutes of application and 20 minutes of tissue rest periods when the second stage of labor begins (the duration of this stage may reach 2 hours in primiparous women).
| Study group | Role | What they receive |
|---|---|---|
| Multifunctional Birthing Ball group | Experimental | Massages will be applied to the experimental group in the first stage of labor for 30 minutes each at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm), respectively.
Perineal heating application is planned to be performed at least twice until the delivery occurs as 20 minutes of application and 20 minutes of tissue rest periods when the second stage of labor begins (the duration of this stage may reach 2 hours in primiparous women). Receives: Device: Multifunctional Birthing ball |
| Control group | No intervention | No intervention will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating pain scores by performing lumbar massage with the massage chair on the birthing ball in order to reduce the back pain experienced during birth.
In order to reduce the back pain experienced during birth, the experimental group received massages in the first stage of birth, respectively; It will be applied for 30 minutes at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm). To determine low back pain at birth, VAS (visual analogue scale) scores will be evaluated a total of three times at all these stages. In the control group, VAS scores will be evaluated three times without massage application for the same period of time.
Measured: during the intervention
Evaluating perineal pain with perineal heating application
Perineal heating application is planned to be performed at least twice when the second phase of labor begins (in primiparas, this phase may last up to 2 hours), with a 20-minute application and a 20-minute tissue rest period until birth. To determine perineal pain, VAS (visual analogue scale) scores will be evaluated twice in all these stages. In the control group, VAS scores will be evaluated twice at the same time without heating.
Measured: during the intervention
Applying the "Birth Satisfaction Scale" to measure the woman's satisfaction with her birth experience in the postpartum period.
Finally, in the postpartum period, the "Birth Satisfaction Scale" consisting of 30 items will be filled in to measure the woman's satisfaction with her birth experience. The original "Birth Satisfaction Scale (BSS)" was developed by Caroline Hollins in 2009. A Turkish validity and reliability study was conducted by Cosar Cetin F. and his colleagues in 2015. Responses to this scale, which is a 5-point Likert type; Absolutely I agree. 5; I agree. 4; I'm undecided 3; Disagree 2; Strongly Disagree: scores as 1. In the scale items; Items 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25, and 29 are scored as reversed items. The total number of points to be obtained from the scale varies between 30 and 150 points. Subthemes in the scale were determined as quality of care, birth environment, adequate support and relationships with health professionals. High scores from the scale indicate that the woman is more satisfied with birth.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start2 Jan 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
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.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Mammadov, Near East University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229808
- Sponsor's protocol ID
- YDU/2021/93-1378
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Design; Investigation of the Effect of Multifunctional Birthing Ball on Perineal and Sacral Pain and Duration of Labor in the First Two Stages of Labor
- ClinicalTrials.gov ID
- NCT06229808
- Acronym / sponsor ID
- YDU/2021/93-1378
- Conditions
- Labor Pain
- Keywords
- Labor Pain, Birth Ball, Active Delivery, Massage, Perineal Warming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 29 Jan 2024 (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: By using the newly designed multifunctional birthing ball, it is aimed to reduce the intense perineal and sacral pain in the first and second stages of labor, to prevent perineal tears, pain and episiotomy opening with perineal heating, to take advantage of the positive effects of the birthing ball on the pelvis to support active labor and shorten the duration of labor, and to increase the satisfaction of mothers with labor by reducing anxiety and pain.
Materials and Methods: The multifunctional birthing ball will support the active movements of the pregnant woman, as well as warming the perineum while providing lumbar and back massage. The multifunctional birthing ball was developed by researchers and manufactured by the Near East University 3D Lab. The bottom of the ball is made of flexible and explosion-proof material filled with air. The purpose of the ball is to enable the pregnant woman to make swinging and bouncing movements during active labor. The massager and heating pad will be controlled by a single electronic circuit. Three different massage modes can be selected: continuous, intermittent and fluctuating. The heating pad can be turned on and off with a single button and the temperature can be adjusted (decrease-increase). To prevent overheating and tissue damage, a maximum temperature of 42 °C was fixed on the control. The inner padding is made of a material that protects both the massager and the heating pad from external factors and also serves as a seat. The shape of the device is designed to ensure that the massager is in full contact with the waist when the pregnant woman sits on the ball. The coating of the massage chair and heating pad is made of cleanable material suitable for hospital use.
Detailed description
This study was designed to experimentally investigate the effect of a multifunctional birthing ball on perineal pain, sacral pain, total duration of labor, perineal tears, and women's satisfaction with the birth experience during the first and second stages of labor in pregnant women who will deliver vaginally. Pregnant women to be included in the experimental and control groups should meet the following criteria:
- First-time mothers
- At term (37-42 weeks of gestation)
- Single fetal gestation
- Cervical dilatation of 3 cm or greater
- Expected spontaneous delivery
- No pregnancy complications or systemic diseases
- No history of cephalopelvic disproportion, placenta previa, placental abruption, or fetal distress
- Willingness to participate in the study
- Age between 18 and 35 years
Experimental Intervention Participants in the experimental group will receive massages using a multifunctional birthing ball during the first stage of labor. Massages will be administered for 30 minutes each at the end of the latent, active, and transition phases (cervical dilatation 3-4 cm, 5-7 cm, and 8-10 cm, respectively). Visual Analog Scale (VAS) scores will be evaluated three times in each phase to assess low back pain. In the control group, VAS scores will be evaluated three times without massage application for the same periods.
Perineal Heating Application
Perineal heating application will be initiated when the second stage of labor begins and will continue until delivery. The heating application will consist of 20 minutes of application followed by 20 minutes of tissue rest. VAS scores will be evaluated two times during these stages to determine perineal pain. In the control group, VAS scores will be evaluated twice without heating application for the same periods.
Postpartum Evaluation
During the postpartum period, each participant will complete a 30-question "Postpartum Interview Form" that will address questions related to the status of perineal integrity at the end of labor, overall childbirth experience, and satisfaction with the birth process. Additionally, each participant will complete the "Birth Satisfaction Scale" - a 30-item questionnaire designed to assess the woman's satisfaction with her birth experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifunctional Birthing Ball group | Experimental | Device: Multifunctional Birthing ballMassages will be applied to the experimental group in the first stage of labor for 30 minutes each at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm), respectively. Perineal heating application is planned to be performed at least twice until the delivery occurs as 20 minutes of application and 20 minutes of tissue rest periods when the second stage of labor begins (the duration of this stage may reach 2 hours in primiparous women). |
| Control group | No intervention | –No intervention will be applied |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- First-time mothers
- At term (37-42 weeks of gestation)
- Single fetal gestation
- Cervical dilatation of 3 cm or greater
- Expected spontaneous delivery
Key exclusion criteria (3 listed)
- Non-pregnancy related chronic illness
- Pregnancy-related illness
- Pregnancy complications
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 |
|---|---|---|
| Multifunctional Birthing ballIn order to reduce low back pain in labor, massages will be applied to the experimental group in the first stage of labor for 30 minutes each at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm), respectively. Perineal heating application is planned to be performed at least twice until the delivery occurs as 20 minutes of application and 20 minutes of tissue rest periods when the second stage of labor begins (the duration of this stage may reach 2 hours in primiparous women). | Device | Multifunctional Birthing Ball group |
Primary outcome
Evaluating pain scores by performing lumbar massage with the massage chair on the birthing ball in order to reduce the back pain experienced during birth.
Time frame: during the intervention
In order to reduce the back pain experienced during birth, the experimental group received massages in the first stage of birth, respectively; It will be applied for 30 minutes at the end of the latent, active and transition phases (cervical dilatation 3-4 cm, 5-7 cm, 8-10 cm). To determine low back pain at birth, VAS (visual analogue scale) scores will be evaluated a total of three times at all these stages. In the control group, VAS scores will be evaluated three times without massage application for the same period of time.
Evaluating perineal pain with perineal heating application
Time frame: during the intervention
Perineal heating application is planned to be performed at least twice when the second phase of labor begins (in primiparas, this phase may last up to 2 hours), with a 20-minute application and a 20-minute tissue rest period until birth. To determine perineal pain, VAS (visual analogue scale) scores will be evaluated twice in all these stages. In the control group, VAS scores will be evaluated twice at the same time without heating.
Applying the "Birth Satisfaction Scale" to measure the woman's satisfaction with her birth experience in the postpartum period.
Time frame: immediately after the intervention
Finally, in the postpartum period, the "Birth Satisfaction Scale" consisting of 30 items will be filled in to measure the woman's satisfaction with her birth experience. The original "Birth Satisfaction Scale (BSS)" was developed by Caroline Hollins in 2009. A Turkish validity and reliability study was conducted by Cosar Cetin F. and his colleagues in 2015. Responses to this scale, which is a 5-point Likert type; Absolutely I agree. 5; I agree. 4; I'm undecided 3; Disagree 2; Strongly Disagree: scores as 1. In the scale items; Items 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25, and 29 are scored as reversed items. The total number of points to be obtained from the scale varies between 30 and 150 points. Subthemes in the scale were determined as quality of care, birth environment, adequate support and relationships with health professionals. High scores from the scale indicate that the woman is more satisfied with birth.
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 29 Jan 2024.
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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 Multifunctional Birthing ball in people with Labor Pain, run by Near East University, Turkey at 1 site in Cyprus.
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 7 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 29 Jan 2024. 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 Cyprus. 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?
Evaluating pain scores by performing lumbar massage with the massage chair on the birthing ball in order to reduce the back pain experienced during birth. (time frame: during the intervention). 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?
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 29 Jan 2024.