The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success

NCT07706881 | Not Yet Recruiting

• 1 other identifier: 7
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Although the female body and fetus are physiologically equipped to carry out the birthing process, the increasing medical interventions in the birthing process today are pushing women into the background during labor. This situation can indirectly affect the duration of labor by causing an increase in women's anxiety and perceived pain levels. In this regard, the application of non-pharmacological methods that support women in effectively managing pain, enabling their active participation in childbirth, shortening the duration of the stages of labor, and having low cost and side effects, stands out as an important care option for women. Today, the use of non-pharmacological methods by midwives who play an active role in childbirth and postpartum care is becoming increasingly common. Among the non-pharmacological approaches are distraction techniques; Practices such as deep breathing exercises, early skin-to-skin contact, listening to relaxing music, watching videos, virtual reality applications, communicating, or cognitive focus shifting contribute to a woman's perception of her birthing experience as more controllable and comfortable . This research will be conducted to evaluate the effect of music listening and stress ball application on placental separation time, pain during episiotomy repair, and breastfeeding success in primiparous pregnant women.

Conditions

Primiparity (First-Time Mothers); Breastfeeding; Episiotomy; Labour

Keywords

vaginal delivery; episiotomy pain; breastfeeding success

Outcome Measures

Primary Outcomes (1)

• Placental Separation Time

  Placental separation time will be measured in minutes using a stopwatch from umbilical cord clamping until complete placental expulsion.

  During the third stage of labor

Secondary Outcomes (2)

• Pain Intensity During Episiotomy Repair

  Before, during, and immediately after episiotomy repair.

• Breastfeeding Success

  Within the first postpartum hour after birth.

Study Arms (4)

music performance group

EXPERIMENTAL

Before any procedure is performed, an informed consent form and a pregnancy identification form will be administered. When the baby is born and the cord is clamped, music will be played. When the baby is born and the cord is clamped, a stopwatch will be started. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the music will be terminated, and breastfeeding success will be evaluated with the LATCH Breastfeeding Assessment Scale.

Other: music performance

stress ball application

EXPERIMENTAL

Before any procedure is performed, an informed consent form and a pregnancy profile form will be administered. A stress ball application will be performed when the baby is born and the cord is clamped. A stopwatch will be started when the baby is born and the cord is clamped. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the application (stress ball) will be terminated, and breastfeeding success will be evaluated with the LATCH Lactation Assessment Scale.

Behavioral: stress ball squeezing

both music listening and stress ball application.

EXPERIMENTAL

Before any procedure is performed, an informed consent form and a pregnancy profile form will be administered. When the baby is born and the cord is clamped, both music and stress ball application will be performed. A stopwatch will be started when the baby is born and the cord is clamped. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the application (music, stress ball) will be terminated, and breastfeeding success will be evaluated with the LATCH Breastfeeding Assessment Scale.

Other: music listening and stress ball squeezing

no intervention

NO INTERVENTION

Before any procedure is performed, an informed consent form and a pregnancy profile form will be administered. A stopwatch will be started when the baby is born and the cord is clamped. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the mother's breastfeeding success will be evaluated using the LATCH Lactation Assessment Scale.

Interventions

music performance OTHER

Music will be played during the procedure.

music performance group

stress ball squeezing BEHAVIORAL

The stress ball will be squeezed during the procedure.

stress ball application

music listening and stress ball squeezing OTHER

During the procedure, both music will be played and a stress ball will be squeezed.

both music listening and stress ball application.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: primiparous women who have had vaginal births
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and over,
• The pregnant woman must be at term (37-42 weeks),
• Primiparous,
• Singleton pregnancy,
• Vertex presentation,
• Vaginal delivery,
• Mediolateral episiotomy,
• Healthy newborn

You may not qualify if:

• Bleeding requiring intervention,
• Lacerations other than episiotomy (anal sphincter injury or 3rd or 4th degree tear),
• Interventional labor (with vacuum or forceps),
• Use of anesthesia other than local anesthesia (5 ml lidocaine) before and during episiotomy repair,
• High-risk pregnancy,
• Any complications in the mother or baby,
• Placental separation not spontaneous and removal by intervention

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis Eren University

Bitlis, Bitlis, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• ayşegül şahin çelebi

  not connected

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research assistant Ayşegül Şahin Çelebi

CONTACT

+905524047952; ascelebi@beu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: Control group: Written informed consent and the Pregnant Woman Information Form will be completed before delivery. Following birth and umbilical cord clamping, a stopwatch will be started to record placental separation time. Pain will be assessed using the Visual Analog Scale (VAS) before, during, and after episiotomy repair. After completion of all procedures, breastfeeding success will be evaluated using the LATCH Breastfeeding Assessment Scale. Intervention group: After informed consent and baseline data collection, Group 1 will receive music, Group 2 a stress ball, and Group 3 both interventions immediately after cord clamping. Placental separation time will be recorded, pain assessed using the VAS before, during, and after episiotomy repair, and breastfeeding success evaluated using the LATCH Breastfeeding Assessment Scale after completion of all procedures.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 16, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): December 2, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)