The Effect of St. John's Wort Oil on Wound Healing and Pain in Women Undergoing Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- pre-test post-test
研究概览
简要总结
Cesarean section refers to the surgical procedure in which the fetus is delivered via an incision, typically performed when vaginal delivery is not possible due to high-risk conditions. In recent years, the rate of cesarean deliveries has increased significantly. The quality of treatment and care is crucial in ensuring proper surgical wound healing following cesarean birth. Various new methods and products have been developed for wound healing and care in recent years, some of which are derived from herbal sources. The limitations of pharmacological methods used in the postpartum period, such as treatment failure, concerns about potential harm to the mother and infant, adverse side effects, negative impact on breastfeeding, emergence of resistant microorganisms, and ineffectiveness of current antibiotics, have led individuals to seek alternative natural remedies. Hypericum perforatum (commonly known as St. John's Wort) is frequently used in the postpartum period due to its antimicrobial and antioxidant properties. This study aims to examine the effects of Hypericum perforatum on wound healing and pain in women following cesarean delivery.
详细描述
Cesarean section is a surgical procedure in which the fetus is delivered through an incision when vaginal delivery is not possible due to certain high-risk conditions (1). In recent years, cesarean rates have increased rapidly, showing a 75% rise over the last 15 years (2). While the global cesarean rate was 7% in 1990, it has now reached 21% and is expected to continue increasing over the next decade. In Latin America and the Caribbean, 43% of all births are cesarean deliveries. In countries such as Egypt, Brazil, Cyprus, the Dominican Republic, and Turkey, cesarean births have surpassed vaginal deliveries (3).
Cesarean section is a life-saving intervention when maternal or fetal morbidity and mortality are at risk. However, due to the nature of the surgical procedure and anesthesia, cesarean delivery can lead to numerous physical and psychosocial problems during the postpartum period. One of the main factors negatively affecting infant care, mother-infant interaction, and the mother's ability to resume daily activities after cesarean delivery is the presence of a surgical wound. Delayed wound healing and wound-related complications are among the major issues encountered in the postpartum period (4). Approximately 5% of women who undergo cesarean delivery experience wound site complications such as hematoma, infection, and seroma (5).
A wound is defined as the disruption of the anatomical and functional integrity of intact skin and tissues due to trauma or surgical intervention (6,7). Wound healing is a critical process following cesarean delivery and is influenced by both local and systemic factors. Local factors include infection, oxygenation, necrotic tissue, foreign bodies, repeated trauma, and radiation exposure, while systemic factors encompass gender, chronic diseases, advanced age, immunodeficiency, nutritional deficiencies, smoking and alcohol use, obesity, medication use, and stress (8). Successful wound healing requires the orderly progression of distinct healing phases: hemostasis, inflammation, proliferation, and remodeling (5,6,8,9).
The quality of treatment and care plays a crucial role in the healing of surgical wounds after cesarean section (10). In recent years, new methods and products have been developed for wound care and healing, some of which are derived from herbal sources (9). Failures in pharmacological treatments applied in the postpartum period, concerns about the safety of these methods for the mother and infant, the presence of side effects, negative impacts on breastfeeding, the emergence of resistant microorganisms, and the inability of existing antibiotics to address these issues have all prompted individuals to seek natural alternatives (7,10,11,12).
These natural alternatives, collectively referred to as Traditional and Complementary Medicine (TCM), are defined by the World Health Organization (WHO) as "a set of knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, used in the maintenance of health as well as in the prevention, diagnosis, improvement, or treatment of physical and mental illnesses" (13). TCM practices are widely used around the world. In China, they account for 40% of all medical treatments, and 80% of the population in Asia and Africa use TCM in primary healthcare services. In developed countries, 70% of the population in Canada, 75% in France, 42% in the USA, 30% in New Zealand, and 53% in Singapore report using TCM methods (7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteering to participate in the research,
- •Having had a cesarean section,
- •Her first cesarean section,
- •Being fluent in Turkish.
排除标准
- •Not wanting to participate in the research,
- •The existence of a communication barrier.
研究组 & 干预措施
Experimental group
At the first follow-up, wound dressing will be performed using St. John's Wort oil, and participants will be instructed on how to apply the dressing themselves. They will be advised to apply the oil to the incision site once daily. With the participant's consent, photographs of the incision area will be taken.
At the second follow-up, on postpartum day 15, the incision site will be evaluated by the researcher. With consent, photographs of the incision site will again be taken. Participants will be instructed to continue applying the oil daily.
The third follow-up will take place on postpartum day 25, during which the REEDA Scale and the Numeric Rating Scale (NRS) will be administered to assess wound healing and pain.
干预措施: Caesarean section scar dressing with St. John's wort oil (Other)
control
No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group.
结局指标
主要结局
pre-test post-test
时间窗: 6 months
In the first follow-up, a dressing will be made with St. John's wort oil and the woman will be told how to make a dressing with this oil. It will be explained to the woman to make a dressing with St. John's wort oil at the incision site once a day every day. The incision site will be photographed for women who give permission.
次要结局
未报告次要终点
研究者
GÜLESER ADA
Research Assistant Dr.
Sakarya University
