The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfa… (NCT06935643) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction
144 participantsStarted 2025-05-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between 18-35 years old
* Active phase
* Multipar
* Singleton pregnancy
* No risky pregnancy
* No complications for vaginal delivery
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perineal Pain Assessment
Timeframe: 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.
2
Perineal Trauma Assessment
Timeframe: 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'.
3
Assessing Maternal Satisfaction at Birth
Timeframe: 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.