Perineal PainNCT06935643
The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction
A study testing Birth Ball and Perineal Massage in people with Perineal Pain and Birth Satisfaction, run by Istanbul University - Cerrahpasa.
Trial summary
One of the important causes of perineal trauma is perineal tension. By reducing this tension, perineal trauma can be prevented. Perineal trauma is a birth complication that can be prevented with midwifery approaches. 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
- Perineal Pain, Birth Satisfaction, Perineal Laceration, Tear, or Rupture During Delivery
- What is being tested?
- Birth Ball and Perineal Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Between 18-35 years old
- Active phase
- Multipar
- Singleton pregnancy
- No risky pregnancy
- No complications for vaginal delivery
Show all 12Show fewer
- Gestational week between 37-42
- The amniotic membrane has not opened
- No perineal scar tissue
- The anterior cephalic position of the fetal head
- Can speak and understand Turkish
- Pregnant women who agreed to participate in the study
Who cannot join
- Macrosomic fetus (birth weight over 4000 grams according to ultrasound calculation)
- Vaginal infection and/or sexually transmitted disease
- Research Termination Criteria
- Cesarean section decision following trauma (due to fetal distress etc.)
- Pregnant women who develop complications during labor (instrumental delivery, etc.)
- Pregnant women who wish to withdraw from work
About this study
Official title: The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction During the Intrapartum Period
One of the important causes of perineal trauma is perineal tension. By reducing this tension, perineal trauma can be prevented. Perineal trauma is a birth complication that can be prevented with midwifery approaches. The aim of this study was to investigate the effect of birth ball and perineal massage on perineal pain, perineal trauma and labor satisfaction in the intrapartum period.
Read the detailed description
Perineal trauma is the disruption of perineal integrity that develops in the genital area at birth and occurs spontaneously or as a result of surgical intervention. One of the important causes of perineal trauma is perineal tension. Perineal traumas can be prevented by reducing this tension.Birth ball and perineal massage are recommended approaches to prevent perineal trauma from the active phase. As a result of these approaches, an increase in birth satisfaction, an increase in quality of life, a decrease in perineal pain and continuity of communication between mother and baby are provided.Massage is started by applying a lubricant to the hands and the fingers are placed into the vagina until the first knuckle. The thumb and index fingers are moved in a "U" shape by pressing the rectum and the tension of the perineal muscles is reduced. In the Positive Birth Experience Booklet published by the World Health Organization, it recommends perineal massage in the second stage of labor to facilitate vaginal delivery and reduce perineal trauma. At a high level of evidence, perineal massage is recommended to prevent third and fourth degree perineal trauma. Perineal trauma care is a condition that increases the cost of delivery, and perineal massage reduces the cost of care and provides quality midwifery care.The use of a birth ball in the intrapartum period increases uterine blood flow, relaxes the muscles and thus reduces pain. Its use is recommended because of its effects on the birth process such as completing the engagement of the fetal head, shortening the duration of the latent phase and increasing the comfort of labor. In addition, the movement of the mother on the birth ball increases the flexibility of the perineal muscles and reduces the risk of perineal trauma. The use of a birth ball is recommended in the first and second stages of labor.
- Being tested
- Birth Ball, Perineal Massage, Control Group
- Keywords
- Birth Satisfaction, Perineal trauma, Birth Ball, The Effect of perineal massage, The Effect of birth ball
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth BallOther
Written and verbal consent will be obtained by giving information about the study.The Pregnant Diagnosis Form will be filled out.When the cervical opening is 4-5 cm, 6-7 cm and 8-10 cm, the pregnant woman will have a birth ball application for 10 minutes. Visual Analog Scale (VAS) will be completed before and after each application. During labor, the Labor Monitoring and Perineal Trauma Assessment Form will be completed and the presence/degree of perineal trauma will be evaluated.Visual Analog Scale (VAS) will be completed at the 1st hour postpartum.At the 4th hour postpartum, the Visual Analog Scale (VAS) and The Scale for Measuring Maternal Satisfaction in Birth will be completed.
Perineal MassageOther
Written and verbal consent will be obtained by giving information about the study.The Pregnant Diagnosis Form will be filled out. When the cervical opening is 4-5 cm, 6-7 cm and 8-10 cm, 10 minutes of perineal massage will be applied to the pregnant woman. Visual Analog Scale (VAS) will be completed before and after each application. During labor, the Labor Monitoring and Perineal Trauma Assessment Form will be completed and the presence/degree of perineal trauma will be evaluated.Visual Analog Scale (VAS) will be completed at the 1st hour postpartum.At the 4th hour postpartum, the Visual Analog Scale (VAS) and The Scale for Measuring Maternal Satisfaction in Birth will be completed.
Control GroupOther
Pregnant women in the control group will not receive any intervention. Pregnant women in this group will only receive routine midwifery care.
Written and verbal consent will be obtained by giving information about the study.Pregnancy Diagnosis Form will be filled.When the cervical opening is 4-5 cm, 6-7 cm and 8-10 cm, Visual Analog Scale (VAS) will be completed. During labor, the Labor Monitoring and Perineal Trauma Assessment Form will be completed and the presence/degree of perineal trauma will be evaluated.Visual Analog Scale (VAS) will be completed at the 1st hour postpartum.At the 4th hour postpartum, the Visual Analog Scale (VAS) and The Scale for Measuring Maternal Satisfaction in Birth will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Birth Ball Group | Active comparator | The use of a birth ball is a non-pharmacological method to reduce labor pain is one of the methods. It is a low-cost and reliable method of dealing with pain. Birth balls of different sizes and shapes such as Swiss ball, bean-shaped, peanut-shaped are used. The birth ball , which is usually 55 cm or 65 cm in diameter, is round and plastic. Sitting on the birth ball, rocking and pelvic rotation movements reduce pain in pregnant women and facilitate labor. Receives: Other: Birth Ball |
| Perineal Massage Group | Active comparator | Perineal massage; It is a safe method of preventing perineal trauma. As a result of studies on the use of liquid petroleum jelly for perineal massage application, the importance of vaseline perineal massage in preventing the development of trauma has been emphasized. Thanks to the lubricating effect of liquid petroleum jelly, it has been observed that the risk of developing perineal trauma is reduced Receives: Other: Perineal Massage |
| Control Group | Active comparator | Pregnant women in the control group will be given routine midwifery care without any intervention. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal Pain Assessment
The Visual Analog Scale (VAS) is a scale used to measure pain and other subjective symptoms. It was first introduced by Hayes and Patterson in 1921. The scale has a maximum score of 10 and a minimum score of zero. And as the scale score increases, the measure of pain also increases. High scores indicate severe pain, while low scores indicate reduced pain. When cervical dilatation is 4-5 cm, 6-7 cm and 8-10 cm, the pregnant woman is asked to mark the pain score from one to ten on the VAS (Visual Analog Scale) score, and then massage is applied for 10 minutes.
Measured: Cervical dilatation will assses is 4-5 cm, 6-7 cm ve 8-10 cm until delivery. Pain will be evaluated at the 1st and 4th hour after delivery.
Perineal Trauma Assessment
The Labor Monitoring and Perineal Trauma Assessment Form, prepared by the researcher in line with the literature, consists of 24 questions that question information about labor, the presence/degree of perineal trauma and information about the newborn. Perineal trauma will be evaluated by considering the recommendations of the International Incontinence Association and RCOG (2015). The form will be completed by the researcher during labor.
Measured: Perineal trauma will be assessed within 1 hour after birth.If the trauma has developed, it is marked as 'developed'; if the trauma has not developed, it is marked as 'not developed'.
Assessing Maternal Satisfaction at Birth
Developed in 2009 by Güngör and Beji, the Maternal Satisfaction in Childbirth Assessment Scale is a 5-point Likert-type scale consisting of 43 items and 10 sub-dimensions. The sub-dimensions of the scale are perception of the health care team, nursing care during the birth process, comfort, participation in decisions and information, meeting her baby, care in the postpartum period, hospital room, hospital facilities, respect for privacy and meeting expectations. the Maternal Satisfaction in Childbirth Assessment Scale is applied to women who have just given birth.The sum of the scores of all items in the scale gives the "total scale score". The total raw score ranges from 43-215. As the total score obtained from the scale increases, the satisfaction levels of the mothers with the care they receive in the hospital during normal birth increase. The point score calculated for the Maternal Satisfaction Assessment Scale in Normal Birth was determined as 150.5 (≥150.5 sThe cronbach alpha va
Measured: At the 4th hour after birth, maternal satisfaction will be assess.As the total score obtained from the scale increases, the satisfaction levels of mothers regarding the care they receive in the hospital during normal childbirth also increase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study with 3 groups, there were perineal massage group, birth ball group and control group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İrem Altun, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935643
- Sponsor's protocol ID
- IUC-EBE-IA-01
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 24 Apr 2025
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction During the Intrapartum Period
- ClinicalTrials.gov ID
- NCT06935643
- Acronym / sponsor ID
- IUC-EBE-IA-01
- Keywords
- Birth Satisfaction, Perineal trauma, Birth Ball, The Effect of perineal massage, The Effect of birth ball
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 20 Apr 2025 (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.
One of the important causes of perineal trauma is perineal tension. By reducing this tension, perineal trauma can be prevented. Perineal trauma is a birth complication that can be prevented with midwifery approaches. The aim of this study was to investigate the effect of birth ball and perineal massage on perineal pain, perineal trauma and labor satisfaction in the intrapartum period.
Detailed description
Perineal trauma is the disruption of perineal integrity that develops in the genital area at birth and occurs spontaneously or as a result of surgical intervention. One of the important causes of perineal trauma is perineal tension. Perineal traumas can be prevented by reducing this tension.Birth ball and perineal massage are recommended approaches to prevent perineal trauma from the active phase. As a result of these approaches, an increase in birth satisfaction, an increase in quality of life, a decrease in perineal pain and continuity of communication between mother and baby are provided.Massage is started by applying a lubricant to the hands and the fingers are placed into the vagina until the first knuckle. The thumb and index fingers are moved in a "U" shape by pressing the rectum and the tension of the perineal muscles is reduced. In the Positive Birth Experience Booklet published by the World Health Organization, it recommends perineal massage in the second stage of labor to facilitate vaginal delivery and reduce perineal trauma. At a high level of evidence, perineal massage is recommended to prevent third and fourth degree perineal trauma. Perineal trauma care is a condition that increases the cost of delivery, and perineal massage reduces the cost of care and provides quality midwifery care.The use of a birth ball in the intrapartum period increases uterine blood flow, relaxes the muscles and thus reduces pain. Its use is recommended because of its effects on the birth process such as completing the engagement of the fetal head, shortening the duration of the latent phase and increasing the comfort of labor. In addition, the movement of the mother on the birth ball increases the flexibility of the perineal muscles and reduces the risk of perineal trauma. The use of a birth ball is recommended in the first and second stages of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- In the study with 3 groups, there were perineal massage group, birth ball group and control group.
| Arm | Type | Receives |
|---|---|---|
| Birth Ball Group | Active comparator | Other: Birth BallThe use of a birth ball is a non-pharmacological method to reduce labor pain is one of the methods. It is a low-cost and reliable method of dealing with pain. Birth balls of different sizes and shapes such as Swiss ball, bean-shaped, peanut-shaped are used. The birth ball , which is usually 55 cm or 65 cm in diameter, is round and plastic. Sitting on the birth ball, rocking and pelvic rotation movements reduce pain in pregnant women and facilitate labor. |
| Perineal Massage Group | Active comparator | Other: Perineal MassagePerineal massage; It is a safe method of preventing perineal trauma. As a result of studies on the use of liquid petroleum jelly for perineal massage application, the importance of vaseline perineal massage in preventing the development of trauma has been emphasized. Thanks to the lubricating effect of liquid petroleum jelly, it has been observed that the risk of developing perineal trauma is reduced |
| Control Group | Active comparator | Other: Control GroupPregnant women in the control group will be given routine midwifery care without any intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Between 18-35 years old
- Active phase
- Multipar
- Singleton pregnancy
- No risky pregnancy
Key exclusion criteria (6 listed)
- Macrosomic fetus (birth weight over 4000 grams according to ultrasound calculation)
- Vaginal infection and/or sexually transmitted disease
- Research Termination Criteria
- Cesarean section decision following trauma (due to fetal distress etc.)
- Pregnant women who develop complications during labor (instrumental delivery, etc.)
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 |
|---|---|---|
| Birth BallWritten and verbal consent will be obtained by giving information about the study.The Pregnant Diagnosis Form will be filled out.When the cervical opening is 4-5 cm, 6-7 cm and 8-10 cm, the pregnant woman will have a birth ball application for 10 minutes. Visual Analog Scale (VAS) will be completed before and after each application. During labor, the Labor Monitoring and Perineal Trauma Assessment Form will be completed and the presence/degree of perineal trauma will be evaluated.Visual Analog Scale (VAS) will be completed at the 1st hour postpartum.At the 4th hour postpartum, the Visual Analog Scale (VAS) and The Scale for Measuring Maternal Satisfaction in Birth will be completed. | Other | Birth Ball Group |
| Perineal MassageWritten and verbal consent will be obtained by giving information about the study.The Pregnant Diagnosis Form will be filled out. When the cervical opening is 4-5 cm, 6-7 cm and 8-10 cm, 10 minutes of perineal massage will be applied to the pregnant woman. Visual Analog Scale (VAS) will be completed before and after each application. During labor, the Labor Monitoring and Perineal Trauma Assessment Form will be completed and the presence/degree of perineal trauma will be evaluated.Visual Analog Scale (VAS) will be completed at the 1st hour postpartum.At the 4th hour postpartum, the Visual Analog Scale (VAS) and The Scale for Measuring Maternal Satisfaction in Birth will be completed. | Other | Perineal Massage Group |
| Control GroupPregnant women in the control group will not receive any intervention. Pregnant women in this group will only receive routine midwifery care. Written and verbal consent will be obtained by giving information about the study.Pregnancy Diagnosis Form will be filled.When the cervical opening is 4-5 cm, 6-7 cm and 8-10 cm, Visual Analog Scale (VAS) will be completed. During labor, the Labor Monitoring and Perineal Trauma Assessment Form will be completed and the presence/degree of perineal trauma will be evaluated.Visual Analog Scale (VAS) will be completed at the 1st hour postpartum.At the 4th hour postpartum, the Visual Analog Scale (VAS) and The Scale for Measuring Maternal Satisfaction in Birth will be completed. | Other | Control Group |
Primary outcome
Perineal Pain Assessment
Time frame: Cervical dilatation will assses is 4-5 cm, 6-7 cm ve 8-10 cm until delivery. Pain will be evaluated at the 1st and 4th hour after delivery.
The Visual Analog Scale (VAS) is a scale used to measure pain and other subjective symptoms. It was first introduced by Hayes and Patterson in 1921. The scale has a maximum score of 10 and a minimum score of zero. And as the scale score increases, the measure of pain also increases. High scores indicate severe pain, while low scores indicate reduced pain. When cervical dilatation is 4-5 cm, 6-7 cm and 8-10 cm, the pregnant woman is asked to mark the pain score from one to ten on the VAS (Visual Analog Scale) score, and then massage is applied for 10 minutes.
Perineal Trauma Assessment
Time frame: Perineal trauma will be assessed within 1 hour after birth.If the trauma has developed, it is marked as 'developed'; if the trauma has not developed, it is marked as 'not developed'.
The Labor Monitoring and Perineal Trauma Assessment Form, prepared by the researcher in line with the literature, consists of 24 questions that question information about labor, the presence/degree of perineal trauma and information about the newborn. Perineal trauma will be evaluated by considering the recommendations of the International Incontinence Association and RCOG (2015). The form will be completed by the researcher during labor.
Assessing Maternal Satisfaction at Birth
Time frame: At the 4th hour after birth, maternal satisfaction will be assess.As the total score obtained from the scale increases, the satisfaction levels of mothers regarding the care they receive in the hospital during normal childbirth also increase.
Developed in 2009 by Güngör and Beji, the Maternal Satisfaction in Childbirth Assessment Scale is a 5-point Likert-type scale consisting of 43 items and 10 sub-dimensions. The sub-dimensions of the scale are perception of the health care team, nursing care during the birth process, comfort, participation in decisions and information, meeting her baby, care in the postpartum period, hospital room, hospital facilities, respect for privacy and meeting expectations. the Maternal Satisfaction in Childbirth Assessment Scale is applied to women who have just given birth.The sum of the scores of all items in the scale gives the "total scale score". The total raw score ranges from 43-215. As the total score obtained from the scale increases, the satisfaction levels of the mothers with the care they receive in the hospital during normal birth increase. The point score calculated for the Maternal Satisfaction Assessment Scale in Normal Birth was determined as 150.5 (≥150.5 sThe cronbach alpha va
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Birth Ball and Perineal Massage in people with Perineal Pain and Birth Satisfaction, run by Istanbul University - Cerrahpasa.
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 12 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Perineal Pain Assessment (time frame: Cervical dilatation will assses is 4-5 cm, 6-7 cm ve 8-10 cm until delivery. Pain will be evaluated at the 1st and 4th hour after delivery.). 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 24 Apr 2025.