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

NCT06935643 | Not Yet Recruiting

• 1 other identifier: IUC-EBE-IA-01
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Birth Satisfaction; Perineal trauma; Birth Ball; The Effect of perineal massage; The Effect of birth ball

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  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.

Study Arms (3)

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.

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

Other: Perineal Massage

Control Group

ACTIVE COMPARATOR

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

Other: Control Group

Interventions

Birth Ball 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.

Birth Ball Group

Perineal Massage 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.

Perineal Massage Group

Control Group 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Lacerations

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student

Model Details: In the study with 3 groups, there were perineal massage group, birth ball group and control group.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 20, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share