The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction

NCT ID: NCT06935643

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-10-01

Brief 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.

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.

Conditions

Perineal Pain; Birth Satisfaction; Perineal Laceration, Tear, or Rupture During Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Birth Ball Group

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.

Group Type: ACTIVE_COMPARATOR

Birth Ball

Intervention Type: OTHER

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 Massage Group

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

Group Type: ACTIVE_COMPARATOR

Perineal Massage

Intervention Type: OTHER

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 Group

Pregnant women in the control group will be given routine midwifery care without any intervention.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

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.

Interventions

Birth Ball

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.

Intervention Type: OTHER

Perineal Massage

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.

Intervention Type: OTHER

Control Group

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

İrem Altun

Master Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IUC-EBE-IA-01

Identifier Type: -

Identifier Source: org_study_id