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Primiparity (First-Time Mothers)NCT07706881

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

A study testing music performance, stress ball squeezing and music listening and stress ball squeezing in people with Primiparity (First-Time Mothers) and Breastfeeding, run by Bitlis Eren University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
music performance, stress ball squeezing and music listening and stress ball squeezing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Nov 2026to 2 Dec 2027
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Research assistant Ayşegül Şahin Çelebi contact

+905524047952

ascelebi@beu.edu.tr

Turkey (Türkiye)1 site
  • Bitlis Eren University

    Bitlis, Bitlis

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

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 relegating women to 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 context, 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.

Non-pharmacological methods, which play a significant role in supporting woman-centered childbirth care, not only contribute to pain management but also help improve maternal and neonatal outcomes by supporting the physiological progress of labor . The placental phase, the third stage of labor, is a process that begins with the birth of the fetus and ends with the separation and expulsion of the placenta and its appendages from the uterus, generally encompassing the first 5-30 minutes following delivery . It has been reported that non-pharmacological methods used in labor contribute to the more orderly progression of physiological processes by reducing the mother's pain and stress levels. Distraction and relaxation-based practices such as mother-baby skin-to-skin contact, listening to music, and stress balls can support the mother's relaxation and positively influence neurohormonal responses; in particular, by increasing oxytocin release, they can support the effectiveness of uterine contractions and contribute to facilitating the placental separation process. In addition, increased oxytocin release is important for initiating early lactation and supporting milk production. In their study, Farisoğlu et al. (2019) stated that the placental separation process after vaginal delivery without any intervention is between 10-15 minutes. Literature shows that this time can be shortened using non-pharmacological methods. In a study published by Gündüz and Öztürk in 2023, skin-to-skin contact applied during the third stage of labor resulted in a placental separation time of 7.05 minutes in the experimental group and 13.41 minutes in the control group, and it was found to increase breastfeeding success. In Karaman's 2017 study, the time to placental separation during delivery was found to be 16.57 minutes in the study group and 21.00 minutes in the control group .

One of the interventions performed during labor is an episiotomy. An episiotomy is a procedure involving the surgical widening of the perineal tissue to facilitate fetal delivery during the second stage of labor. A significant consequence of episiotomy is pain. Pain and stress responses can negatively impact breastfeeding by suppressing oxytocin, a hormone that plays a key role in milk production and release. Therefore, effective pain management is crucial for maintaining the mother's psychological well-being, strengthening the mother-infant bond, and initiating breastfeeding early. While commonly used to reduce pain and anxiety during episiotomy repair, lidocaine-derived local anesthetics, sedatives, and hypnotics are reported to have some side effects on both maternal and neonatal health. The use of these medications can lead to undesirable conditions such as changes in fetal heart rate, hypothermia, hypotonia, respiratory depression or apnea in the newborn, and hypotension in the mother . Therefore, in current obstetric care, there is a growing interest in non-pharmacological methods during episiotomy repair that have a low risk of side effects, increase maternal comfort, and support pain management, in addition to pharmacological methods.

In a study by Baradwan et al., it was found that early skin-to-skin contact during episiotomy significantly reduced pain scores during episiotomy repair. A study by Gökduman Keleş, using virtual reality glasses with music, found that perceived pain levels were lower during episiotomy repair. Reducing pain and anxiety during childbirth lowers levels of stress hormones such as cortisol and catecholamines, supporting oxytocin release; this physiological process contributes to the regulation of uterine contractions and increased maternal relaxation. Oxytocin plays a critical role not only in the physiological progression of childbirth but also in initiating and maintaining breastfeeding in the postpartum period. By activating the milk let-down reflex, it facilitates the transfer of breast milk to the baby; it also contributes to relaxation, reduced stress levels in the mother, and strengthening the mother-baby bond. Therefore, it is thought that non-pharmacological practices that support oxytocin release during childbirth can positively contribute not only to improving the birthing experience but also to the early initiation and maintenance of breastfeeding by reducing maternal stress and pain levels. Since breastfeeding is a fundamental care practice in protecting and improving maternal and newborn health, these methods are reported to play an important role in supporting breastfeeding success.

Music is one of the methods frequently used today as a complementary therapy for physical, mental, and surgical procedures. Studies have shown promising results in reducing anxiety and stress levels in mothers and improving fetal parameters (such as heart rate variability). Furthermore, music therapy positively affects the mother's lactation process. Studies supporting this exist in the literature. Studies by Kır (2020) and Soyer (2017) concluded that listening to music such as white noise and lullabies positively influenced breastfeeding.

Stress balls are a simple and effective distraction method during painful procedures. Virtual reality, music therapy, and stress ball applications used to distract patients undergoing outpatient gynecological procedures have been effective in reducing anxiety and pain and increasing patient satisfaction. Another study examining the effect of stress ball use on individuals' pain, anxiety, and satisfaction levels reported that participants who used stress balls had lower pain and anxiety levels and significantly higher satisfaction levels.

The use of non-pharmacological methods applied by midwives in childbirth and postpartum care is becoming increasingly common today. These methods include distraction techniques such as deep breathing exercises, early skin-to-skin contact, listening to relaxing music, watching videos, virtual reality applications, and cognitive focus shifting, which contribute to a woman's perception of the birth experience as more controlled and comfortable.

Although it has been reported that listening to music that provides auditory relaxation and using a stress ball, a distraction-based method, are effective in reducing stress and pain perception, evidence regarding the outcomes of these methods in the third stage of labor is limited. While there are studies in the literature examining the effects of music on pain and breastfeeding, no research has been found that evaluates its effect on the time to placental separation. Similarly, although stress ball application has been studied in different areas such as endoscopy, prostate biopsy, nail surgery, and pain and comfort management during the active phase of labor, a study evaluating its effects on placental separation time, perceived pain during episiotomy repair, and breastfeeding success has not been found. Therefore, a combined evaluation of the effects of music therapy and stress ball applications on placental separation time, episiotomy pain, and breastfeeding success will fill a significant gap in the literature and contribute to the development of evidence-based care practices for the third stage of labor. Furthermore, it is expected that the findings will support the safe separation of the placenta within the physiological process, increase maternal comfort, strengthen breastfeeding success, reduce the need for pharmacological analgesia, and contribute to the dissemination of woman-centered childbirth care by encouraging the integration of low-cost, easily applicable interventions that can be implemented under midwife-led leadership into clinical practice. This research; This study will be conducted to evaluate the effects of music therapy and stress ball application on placental separation time, pain during episiotomy repair, and breastfeeding success in primiparous pregnant women.

Being tested
music performance, stress ball squeezing, music listening and stress ball squeezing
Keywords
vaginal delivery, episiotomy pain, breastfeeding success
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • music performanceOther

    Music will be played during the procedure.

  • stress ball squeezingBehavioural

    The stress ball will be squeezed during the procedure.

  • music listening and stress ball squeezingOther

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

Study groups in NCT07706881
Study groupRoleWhat they receive
music performance groupExperimentalBefore 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.
Receives: Other: music performance
stress ball applicationExperimentalBefore 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.
Receives: Behavioral: stress ball squeezing
both music listening and stress ball application.ExperimentalBefore 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.
Receives: Other: music listening and stress ball squeezing
no interventionNo interventionBefore 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Placental Separation Time

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

    Measured: During the third stage of labor

Secondary outcomes (2)
  1. Pain Intensity During Episiotomy Repair

    Pain intensity will be assessed using the Visual Analog Scale (VAS) before, during, and after episiotomy repair.

    Measured: Before, during, and immediately after episiotomy repair.

  2. Breastfeeding Success

    Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool.

    Measured: Within the first postpartum hour after birth.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start2 Nov 2026 (estimated)
  3. Primary completion2 Feb 2027 (estimated)
  4. Study completion2 Dec 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07706881
Sponsor's protocol ID
7
Status last verified
Jun 2026
First submitted
18 Jun 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: patient privacy

Questions about this trial

What is this clinical trial studying?

A study testing music performance, stress ball squeezing and music listening and stress ball squeezing in people with Primiparity (First-Time Mothers) and Breastfeeding, run by Bitlis Eren University at 1 site in Turkey (Türkiye).

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 8 inclusion and 7 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Research assistant Ayşegül Şahin Çelebi (+905524047952, ascelebi@beu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Placental Separation Time (time frame: During the third stage of labor). 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 2 Nov 2026.

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