Effects of Active Oxygen and Negative Ion Sanitary Pads on Episiotomy Pain, Healing, and Postpartum Physical Symptom Severity in Primiparous Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Episiotomy Wound Healing Score
研究概览
简要总结
This study is to assess the impact of sanitary pads infused with active oxygen and negative ions on episiotomy pain, wound healing, and postpartum physical symptoms in primiparous women. Participants will be randomly allocated to either the intervention group, utilizing active oxygen and negative ion pads, or the control group, employing normal postpartum pads. The research will assess pain intensity, recovery advancement, and physical manifestations during the initial postpartum phase. The objective is to ascertain if the intervention offers supplementary advantages relative to usual care.
详细描述
Episiotomy is a surgical incision made during vaginal birth to enlarge the vaginal opening and support delivery. Although it can help prevent complications during childbirth, many women experience pain, discomfort, difficulty sitting, and delayed wound healing after the procedure. In the postpartum period, appropriate hygiene and wound care are essential to reduce discomfort, prevent infection, and support the healing of the perineal area. The tissues around the vulva and vagina become more sensitive due to increased moisture and hormonal changes, making the choice of hygiene products particularly important.
Sanitary pads containing active oxygen and negative ions have recently been introduced as a new type of hygiene product. These components are believed to improve comfort, support wound healing, and reduce irritation. Although their clinical effects in the postpartum period have not yet been extensively studied, their potential benefits make them a promising option for women recovering from episiotomy.
This study aims to examine whether sanitary pads with active oxygen and negative ions can reduce episiotomy pain, support wound healing, and decrease postpartum physical symptoms in primiparous women. Participants will be randomly assigned to either the intervention group using these special pads or the control group using standard postpartum pads. The findings may contribute to determining whether these products offer additional advantages in the early postpartum recovery process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician conducting data analysis will be blinded to group assignments. Participants, care providers, and investigators will not be blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 years or older
- •At least primary school education
- •Gestational age between 37 and 42 weeks
- •Single, live, vaginal birth
- •Mediolateral episiotomy performed
- •Hemoglobin level > 11 mg/dL
- •Voluntary participation and ability to provide informed consent
排除标准
- •History of high-risk pregnancy
- •History of high-risk or complicated labor
- •Use of operative vaginal delivery methods (forceps, vacuum, etc.)
- •Presence of additional perineal lacerations, including 3rd-degree tears or anal sphincter injury
- •Cephalopelvic disproportion
- •Postpartum hemorrhage
- •Newborn requiring NICU care
- •Diagnosis of vaginal fungal infection or sexually transmitted infections (e.g., herpes simplex, HPV)
研究组 & 干预措施
Pad Group
Participants in this group will use sanitary pads containing active oxygen and negative ions during the early postpartum period following episiotomy. All participants will also receive routine postpartum care.
干预措施: Active Oxygen and Negative Ion Sanitary Pad (Other)
Control Group
Participants in this group will use standard postpartum sanitary pads during the early postpartum period following episiotomy. All participants will also receive routine postpartum care.
干预措施: Standard Postpartum Sanitary Pad (Other)
结局指标
主要结局
Episiotomy Wound Healing Score
时间窗: Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum
Wound healing will be evaluated using the REEDA Scale (Redness, Edema, Ecchymosis, Discharge, Approximation). Each item is scored from 0 to 3, with a total score ranging from 0 to 15. Higher scores indicate poorer wound healing (greater tissue trauma).
Postpartum Physical Symptom Severity
时间窗: Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum
Postpartum physical symptom severity will be measured using the Postpartum Physical Symptom Severity Scale. The scale consists of 18 items, each rated on a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), with total scores ranging from 0 to 54. Higher scores indicate greater severity of postpartum physical symptoms.
Episiotomy Pain Score
时间窗: Measurements will be conducted at: • 24 hours postpartum • 3rd day postpartum • 7th day postpartum
Episiotomy-related pain will be assessed using a 10-point Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Episiotomy Pain Score
时间窗: Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum
Episiotomy-related pain will be assessed using a 10-point Visual Analog Scale (VAS).
次要结局
未报告次要终点