Konya City Hospital
Konya, 42020, Turkey (Türkiye)
NCT Number: NCT07551401
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Konya, 42020, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Selcuk University
Other
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
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