Definition of the Effect of Early Individual Physiotherapy on Evaluation of Pain, Quality of Life, Function of the Pelvic Floor Muscles, and on the Sexual Functions in Women Following an Episiotomy During a Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Pain in the perineum in relation to bodily and motor functions
研究概览
简要总结
Surgical incision of the perineum and the posterior vaginal wall during a vaginal delivery (episiotomy) is among the most common surgical procedures performed in obstetrics. On the condition of having been performed correctly and in certain situations, episiotomy can be beneficial for a mother in decreasing the risk of a serious perineum injury. The benefit for a foetus can lie in acceleration of the final stage of delivery in the event of acute foetal distress. Many adverse effects are however connected to episiotomy. The morbidity connected to episiotomy can affect physical, mental, and social well-being of women during immediate as well as long-term post-partum periods. Currently, there are no universal standards that would describe and recommend physiotherapy for women following episiotomy during the first days, weeks, and months after a delivery. Care about the wound and the resulting scar after giving birth with episiotomy is an important topic because clinical experience shows that scars in the perineal area can have negative effects on the function of the pelvic floor muscles, on perineum pains, sexual health, and on mental well-being of a woman. Treatment of women with perineal wounds therefore requires a multidisciplinary approach, in which doctors, physiotherapists, and other medical professionals should be aware of the impact of a perineal scar on the quality of woman's life. Treatment or perineal scars, external genitalia, and the pelvic floor together with a targeted education of women in individual care after their scars should be part of evidence-based practice.
详细描述
Project Objectives Evaluate the benefits, advantages, and disadvantages of early individual physiotherapy on the selected parameters in women following a performed uncomplicated episiotomy during a vaginal delivery.
Primary objective: Specification of the differences between two groups of expectant mothers following an uncomplicated episiotomy based on the results of a survey. The comparison is carried out between a group of mothers who underwent individual postnatal physiotherapy treatment and another group of mothers that were treated in a standard way.
Secondary objective: Evaluation of the functional changes in mothers that underwent individual physiotherapeutic treatment following an uncomplicated episiotomy.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female aged 18 to 40
- •following an uncomplicated mediolateral episiotomy
- •primipara at term with the cephalic occiput anterior position of the foetus
- •signature of the informed consent and understanding of the study protocol
排除标准
- •premature birth prior to 37+0
- •other presentation than the cephalic occiput anterior position
- •a performed vaginal extraction
- •an associated vaginal rupture
- •an injury of the anal sphincter
- •paravaginal haematoma immediately after birth and before inclusion in the study
- •multiple sclerosis
- •serious neurological disorders
- •connective tissue diseases
- •chronic inflammatory bowel diseases
- •congenital developmental disorders of the external genitalia
结局指标
主要结局
Pain in the perineum in relation to bodily and motor functions
时间窗: Change from baseline to 14-18 weeks and 12-14 months
A Visual Analog Scale (VAS) related to Activities of Daily Living (ADL) is a tool used to assess the impact of pain or other symptoms on a person's ability to perform daily tasks. The VAS typically consists of a horizontal line, usually 10 cm in length, with endpoints labeled to represent the extremes of the symptom's effect-such as "No impact on ADL" at one end and "Completely unable to perform ADL" at the other. Patients are asked to mark a point on the line that represents the extent to which their condition affects their daily activities. The distance from the "No impact" end to the patient's mark is measured in centimeters or millimeters, providing a quantifiable score that reflects the severity of the impact on their ability to carry out ADL. This tool is widely used in clinical settings to monitor changes over time and to evaluate the effectiveness of treatments aimed at improving functional independence.
Pain in the perineal space
时间窗: Change from baseline to 14-18 weeks and 12-14 months
The Short-Form McGill Pain Questionnaire (SF-MPQ) is a concise tool for assessing pain, derived from the original McGill Pain Questionnaire. It consists of three components: the Pain Rating Index (PRI), which includes 15 descriptors (11 sensory and 4 affective) rated on a scale from 0 to 3; the Present Pain Intensity (PPI), where pain is rated on a 6-point scale; and, in some versions, a Visual Analog Scale (VAS), where pain intensity is marked on a 10 cm line.
Complications of healing of birth trauma
时间窗: Change from baseline to 14-18 weeks and 12-14 months
The description refers to the observation of wound complications by a physician, including the appearance of dehiscences (wound separations), secondary healing (delayed healing process), hematomas (localized collections of blood), infections in the wound, and the need for resuturing of the perineum. These complications are typically monitored post-surgery or after childbirth to ensure proper wound healing and to manage any issues that arise.
次要结局
- The functions of the pelvic floor muscles by palpation per vaginam and records them using the PERFECT SCHEME(Change from baseline to 10-14 weeks)
- Satisfaction with physiotherapy(Change from baseline to 10-14 weeks)
- Health related quality of life(Change from baseline to 14-18 weeks and 12-14 months)
- The presence of possible motion synkinesis(Change from baseline to 10-14 weeks)
- Quality of life of people with urinary incontinence(Change from baseline to 14-18 weeks and 12-14 months)
- The functions of the pelvic floor muscles by palpation per vaginam and records them using the OXFORD SCALE(Change from baseline to 10-14 weeks)
- The condition of the scar(Change from baseline to 10-14 weeks)
- The presence of the abdominal separation(Change from baseline to 10-14 weeks)
- Hypermobility(Change from baseline to 10-14 weeks)
- The quality of sexual functions(Change from baseline to 14-18 weeks and 12-14 months)
- The condition of the wound(Change from baseline to 10-14 weeks)
研究者
Ladislav Batalik
Principal Investigator
Brno University Hospital