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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Obstetric Recovery (ObsQoR-11)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the interventions (music therapy, breathing exercises, and virtual reality), participants and intervention providers cannot be blinded. However, outcome assessment will be conducted using standardized measurement tools. Data analysis will be performed by an independent statistician who will be blinded to group allocation. Group assignments will be coded (e.g., Group A, B, C, D) to ensure blinding during statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Music Therapy (Behavioral)
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.
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.
干预措施: Breathing Exercises (Behavioral)
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.
干预措施: Virtual Reality (Behavioral)
结局指标
主要结局
Obstetric Recovery (ObsQoR-11)
时间窗: 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.
Postoperative Pain (VAS)
时间窗: 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.
Gastrointestinal Symptoms (GSRS)
时间窗: 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.
次要结局
- Time to First Flatus(At 4 and 12 hours postoperatively)
研究者
Sureyya Kilic
Specialist Midwife
Selcuk University