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Cesarean SectionNCT07551401

Effects of Music Therapy, Breathing Exercises, and Virtual Reality on Obstetric Recovery, Pain, and Gastrointestinal Symptoms After Cesarean Section

A study testing Music Therapy, Breathing Exercises and Virtual Reality in people with Cesarean Section and Cesarean Section Pain, run by Selcuk University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cesarean section is a common surgical procedure performed to deliver a baby when vaginal birth may pose risks to the mother or infant. Although it is often life-saving, recovery after cesarean section is frequently associated with multiple physical and psychological challenges, including postoperative pain, delayed… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Music Therapy, Breathing Exercises and Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2026to Mar 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

  • Women aged 18 years and older
  • Able to speak and understand Turkish
  • Gestational age between 37 and 42 weeks
  • Undergoing cesarean section under spinal anesthesia
  • Able to communicate and willing to participate
  • No major intraoperative or early postoperative complications (within 0-12 hours), such as severe hemorrhage (>1000 mL), anesthesia-related cardiorespiratory complications, major surgical complications, wound dehiscence, sepsis, or need for intensive care
  • No visual or hearing impairments
  • Having a live, healthy, singleton newborn

Who cannot join

  • Passage of flatus before the intervention
  • Presence of any diagnosed medical condition during pregnancy
  • Development of maternal postpartum complications such as postpartum hemorrhage (>1000 mL), infection, wound dehiscence, sepsis, thromboembolism, or need for intensive care
  • Presence of neonatal complications such as neonatal distress requiring intensive care, congenital anomalies, severe respiratory distress, infection, or perinatal mortality
  • History of chronic pain, gastrointestinal disease, or respiratory disease
  • Diagnosed and treated psychiatric disorders

Trial locations and contacts

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

Sureyya Kilic, Specialist Midwife contact

+90 501 578 99 08

sureyyakilic117@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Selçuk University Faculty of Medicine Hospital

    Konya, Konya, 42020

    Sureyya Kilic, Specialist Midwife, +90 501 578 99 08, sureyyakilic117@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Investigation of the Effects of Music Therapy, Breathing Exercises, and Virtual Reality Application on Obstetric Recovery, Pain, and Gastrointestinal Symptoms Following Cesarean Section: A Randomized Controlled Trial

Cesarean section is a common surgical procedure performed to deliver a baby when vaginal birth may pose risks to the mother or infant. Although it is often life-saving, recovery after cesarean section is frequently associated with multiple physical and psychological challenges, including postoperative pain, delayed gastrointestinal function, reduced mobility, fatigue, and decreased overall well-being. These factors may negatively affect a woman's ability to care for her newborn, initiate breastfeeding, and adapt to the postpartum period.

In recent years, there has been increasing interest in non-pharmacological interventions that can safely support postoperative recovery without causing additional side effects. Among these, music therapy, breathing exercises, and virtual reality applications have been identified as promising approaches. Music therapy may promote relaxation and reduce pain and anxiety through auditory stimulation and emotional regulation. Breathing exercises may enhance parasympathetic activity, improve oxygenation, reduce stress, and support gastrointestinal motility. Virtual reality applications, by providing immersive audiovisual experiences, may reduce pain perception, decrease anxiety, and improve overall comfort through distraction and relaxation mechanisms.

Read more

Although these interventions have individually demonstrated beneficial effects in postoperative care, the existing literature is limited in directly comparing their relative effectiveness within the same study design. Furthermore, most studies have primarily focused on pain outcomes, while other important aspects of recovery, such as obstetric recovery quality and gastrointestinal symptoms, have received less attention.

This randomized controlled trial aims to comparatively investigate the effects of music therapy, breathing exercises, and virtual reality application on obstetric recovery, pain, and gastrointestinal symptoms in women following cesarean section. Participants will be randomly assigned to one of three intervention groups or a control group receiving routine care. Standardized protocols will be applied for each intervention to ensure consistency.

The primary outcomes of this study include obstetric recovery, pain intensity, and gastrointestinal symptoms. By evaluating these outcomes simultaneously, the study aims to provide a more comprehensive understanding of post-cesarean recovery.

The findings of this study are expected to contribute to evidence-based clinical practice by identifying effective, safe, and feasible non-pharmacological interventions that can be integrated into routine post-cesarean care. Ultimately, this research may help improve maternal comfort, accelerate recovery, and enhance the overall postpartum experience for women undergoing cesarean section.

Read the detailed description

Cesarean section is a commonly performed surgical procedure used when vaginal delivery poses a risk to the mother or the infant. Although it has the potential to reduce maternal and neonatal morbidity and mortality when performed for appropriate clinical indications, its use without medical necessity may increase short- and long-term health risks for both the mother and the infant. In recent years, the increasing rates of cesarean section globally and in Türkiye have made the optimization of post-cesarean recovery an important priority in obstetric care.

The recovery process following cesarean section involves multidimensional challenges, including postoperative pain, delayed gastrointestinal motility, reduced mobility, and emotional fluctuations. These factors may negatively affect maternal well-being, adaptation to newborn care, and adjustment to the postpartum period. Therefore, post-cesarean recovery should be addressed not only in terms of physiological healing but also in relation to patient-centered dimensions such as physical comfort, functional capacity, and psychosocial well-being.

Today, obstetric recovery is considered a multidimensional concept encompassing pain, gastrointestinal symptoms, functional independence, and emotional status. Patient-reported outcome measures developed in this context allow for a comprehensive evaluation of recovery after cesarean section.

Gastrointestinal dysfunction, which is one of the most common problems in the post-cesarean period, manifests as delayed gas passage and defecation, abdominal pain, bloating, nausea, and vomiting, and adversely affects the recovery process. This condition may prolong hospital stay and reduce maternal comfort.

In post-cesarean care, there is an increasing emphasis on non-pharmacological interventions that support the multidimensional nature of recovery, rather than focusing solely on pharmacological approaches. Although various methods such as acupuncture, aromatherapy, massage, and relaxation techniques have been reported in the literature, their applicability and scope of effectiveness may be limited.

In this study, music therapy, breathing exercises, and virtual reality applications were selected due to their safety, non-invasive nature, cost-effectiveness, and ease of integration into clinical practice. These interventions may contribute to the recovery process by influencing pain, stress response, and attention through different mechanisms (auditory, respiratory, and audiovisual stimulation).

Music therapy can reduce pain and anxiety by regulating emotional and physiological responses. Breathing exercises may enhance parasympathetic nervous system activity, thereby reducing stress and supporting gastrointestinal motility. Virtual reality applications can reduce pain perception and improve overall comfort through distraction and relaxation mechanisms.

Although the effects of these interventions have been investigated individually in the literature, studies directly comparing them within the same research design are limited. In addition, most existing studies have focused primarily on pain, while multidimensional outcomes such as obstetric recovery and gastrointestinal symptoms have not been sufficiently addressed.

Therefore, this randomized controlled trial aims to comparatively evaluate the effects of music therapy, breathing exercises, and virtual reality applications on obstetric recovery, pain, and gastrointestinal symptoms in women following cesarean section. The findings of this study are expected to contribute to the development of post-cesarean care protocols and support the integration of non-pharmacological interventions into clinical practice.

Being tested
Music Therapy, Breathing Exercises, Virtual Reality
Keywords
Cesarean Section, Obstetric Recovery, Postoperative Pain, Gastrointestinal Symptoms, Music Therapy, Breathing Exercises, Virtual Reality, Postpartum Care
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Music TherapyBehavioural

    Participants will receive music therapy using standardized audio content delivered through wireless headphones. The intervention will be applied in two sessions at the 4th and 12th postoperative hours, each lasting 20 minutes, in a quiet and controlled environment.

  • Breathing ExercisesBehavioural

    Participants will perform guided breathing exercises under researcher supervision. The intervention will be conducted in two sessions at the 4th and 12th postoperative hours, each lasting 20 minutes, using slow and controlled breathing techniques.

  • Virtual RealityBehavioural

    Participants will receive a virtual reality intervention using a headset to view standardized immersive audiovisual content. The intervention will be applied in two sessions at the 4th and 12th postoperative hours, each lasting 20 minutes.

Study groups in NCT07551401
Study groupRoleWhat they receive
Music Therapy GroupExperimentalParticipants in this group will receive music therapy in addition to routine postoperative care. The intervention will be administered in two sessions at the 4th and 12th postoperative hours following cesarean section. Each session will last 20 minutes. Standardized music content will be delivered via wireless headphones in a quiet and controlled environment. Outcome measures will be assessed at the 4th and 12th postoperative hours.
Receives: Behavioral: Music Therapy
Breathing Exercises GroupExperimentalParticipants in this group will perform guided breathing exercises in addition to routine postoperative care. The intervention will be conducted in two sessions at the 4th and 12th postoperative hours. Each session will last 20 minutes and will consist of slow, controlled breathing techniques under researcher supervision. Outcome measures will be assessed at the 4th and 12th postoperative hours.
Receives: Behavioral: Breathing Exercises
Virtual Reality GroupExperimentalParticipants in this group will receive a virtual reality intervention in addition to routine postoperative care. The intervention will be applied in two sessions at the 4th and 12th postoperative hours. Each session will last 20 minutes and will involve standardized immersive audiovisual content delivered via a virtual reality headset in a controlled environment. Outcome measures will be assessed at the 4th and 12th postoperative hours.
Receives: Behavioral: Virtual Reality
Control GroupNo interventionParticipants in this group will receive routine postoperative care according to hospital protocols without any additional intervention. Outcome measures will be assessed at the 4th and 12th postoperative hours.

What is being measured

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

  1. Obstetric Recovery (ObsQoR-11)

    Obstetric recovery will be assessed using the Obstetric Quality of Recovery Score-11 (ObsQoR-11), a validated patient-reported outcome measure evaluating physical comfort, emotional status, functional independence, and pain.

    Measured: At 4 and 12 hours postoperatively

  2. Postoperative Pain (VAS)

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from no pain to worst possible pain.

    Measured: At 4 and 12 hours postoperatively

  3. Gastrointestinal Symptoms (GSRS)

    Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS), which assesses abdominal pain, reflux, diarrhea, indigestion, and constipation. Higher scores indicate more severe symptoms.

    Measured: At 4 and 12 hours postoperatively

Secondary outcomes (1)
  1. Time to First Flatus

    Time to first passage of flatus will be recorded as an indicator of gastrointestinal recovery. Participants will be asked whether flatus has occurred and, if applicable, the exact time will be recorded.

    Measured: At 4 and 12 hours postoperatively

Timeline

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

  1. First posted24 Apr 2026
  2. Study start1 Aug 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:1:1:1 ratio to one of four parallel groups: music therapy, breathing exercises, virtual reality, or routine care control. Randomization will be performed using stratified block randomization according to parity (primiparous/multiparous) and education level (primary, secondary, higher education) to ensure baseline balance across groups. Outcome assessments will be conducted at postoperative 4th and 12th hours using a pretest-posttest design. Each participant will receive only the intervention assigned to her group, and no crossover between groups will occur.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07551401
Sponsor's protocol ID
SU-CS-INTERVENTION-2026-01
Status last verified
Oct 2026
First submitted
18 Apr 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy, Breathing Exercises and Virtual Reality in people with Cesarean Section and Cesarean Section Pain, run by Selcuk 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 6 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: looking for participants now, as of the sponsor's last update on 7 Oct 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 Sureyya Kilic, Specialist Midwife (+90 501 578 99 08, sureyyakilic117@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obstetric Recovery (ObsQoR-11) (time frame: At 4 and 12 hours postoperatively). The study lists 3 primary outcomes in all. 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 7 Oct 2026.

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