- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551401
Effects of Music Therapy, Breathing Exercises, and Virtual Reality on Obstetric Recovery, Pain, and Gastrointestinal Symptoms After Cesarean Section
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.
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sureyya Kilic, Specialist Midwife
- Phone Number: +90 501 578 99 08
- Email: sureyyakilic117@gmail.com
Study Locations
-
-
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Konya, Turkey (Türkiye), 42020
- Konya City Hospital
-
Contact:
- Sureyya Kilic, Specialist Midwife
- Phone Number: +90 501 578 99 08
- Email: sureyyakilic117@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Therapy Group
Participants 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.
|
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.
|
|
Experimental: Breathing Exercises Group
Participants 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.
|
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.
|
|
Experimental: Virtual Reality Group
Participants 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.
|
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.
|
|
No Intervention: Control Group
Participants 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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obstetric Recovery (ObsQoR-11)
Time Frame: At 4 and 12 hours postoperatively
|
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.
|
At 4 and 12 hours postoperatively
|
|
Postoperative Pain (VAS)
Time Frame: At 4 and 12 hours postoperatively
|
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from no pain to worst possible pain.
|
At 4 and 12 hours postoperatively
|
|
Gastrointestinal Symptoms (GSRS)
Time Frame: At 4 and 12 hours postoperatively
|
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.
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At 4 and 12 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Flatus
Time Frame: At 4 and 12 hours postoperatively
|
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.
|
At 4 and 12 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Breathing Exercises
- Music Therapy
Other Study ID Numbers
- SU-CS-INTERVENTION-2026-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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