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临床试验/NCT06306703
NCT06306703已完成不适用

Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women

Duygu Sultan Oge1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG)

研究概览

简要总结

The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods.

详细描述

The pelvic region, from inside to outside, consists of the endopelvic fascia that connects the pelvic organs to the side walls of the pelvis, the levator ani muscle (pubococcygeus, iliococcygeus and puborectalis), perineal membrane (urogenital diaphragm), external genital muscles (ischiocavernosus, bulbospongiosus and transversus perinei superficialis), external genital organs and It consists of skin. The perineal area is clinically the area between the vagina and the anus[1].

When the Levator Ani muscle was examined histochemically under an electron microscope, it was shown that it consisted of Type 1 (slow twitch-67%) and Type 2 (fast twitch-33%) striated muscle fibers. Type 1 fibers are resistant to fatigue and can produce contractions for long periods of time. Type 2 fibers have high contraction strength but have low resistance to fatigue. While Type 2 fibers cause sudden contraction in situations that increase intra-abdominal pressure, such as coughing, sneezing, heavy lifting, Type 1 fibers maintain the tone required for continence without fatigue for a long time [1, 2].

The pelvic floor has important functions in ensuring the continence mechanism, providing structural support to the pelvic openings such as the urethra, vagina and anus, supporting the pelvic organs, and performing vital activities such as sexual function and birth [3, 4].

Damage or weakening of the pelvic floor due to reasons such as pregnancy, birth, newborn weight, menopause, age, obesity, smoking, hysterectomy, constipation, systemic diseases, genetics, bad urination habits, constipation, heavy sports, or tension in the structures that form it. In this case, it may cause problems such as urinary incontinence, anorectal dysfunction, pelvic organ prolapse, pelvic pain or sexual dysfunction, and these pathologies are generally defined as pelvic floor dysfunction[4]. Although pelvic floor problems are not life-threatening, they affect people's psychological, social and physical well-being and negatively affect their quality of life by causing limitations in their work, family, social and sexual lives [5].

The pelvic floor can be evaluated by many different methods. The aim is to objectively evaluate the anatomy of the pelvic floor and pelvic organs and relate symptoms to anatomical findings. The methods used in the evaluation of the pelvic floor muscles are generally observation, palpation, electromyography (EMG), EMG with biofeedback, perineometer, pelvic floor dynamometer, ultrasonographic imaging (USG) and magnetic resonance imaging (MRI)[6]. Evaluations can be performed in the lithotomy position or standing.

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
Double (Participant, Outcomes Assessor)

盲法说明

healthcare provider performing USG evaluation person doing statistical analysis

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Volunteering to participate in the study Getting a score of 25 or more from the "Mini Mental Test" Having pelvic floor muscle contraction ability Not having received pelvic floor muscle training before Vaginal examination Volunteering for education

排除标准

  • Pregnancy Presence of symptomatic pelvic organ prolapse over stage 2 Cooperation problem Presence of urinary infection Epilepsy Accompanying neurological disease

研究组 & 干预措施

group 2, digital vaginal palpation

Experimental

干预措施: group1, group2, group 3 (Other)

group1, verbal instruction

Experimental

干预措施: group1, group2, group 3 (Other)

group 3, perineometer

Experimental

干预措施: group1, group2, group 3 (Other)

结局指标

主要结局

ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG)

时间窗: at the beginning 5 minutes, at the end 5 minutes

During evaluation with 2D USG, hiatal aperture measurements will be made at rest and at maximum voluntary contraction. Measurements will be repeated before and after individuals receive training, and any numerical changes that may occur will be recorded\[11,12\].

Pelvic Floor Muscle Strength and Endurance:

时间窗: 5 minutes

Pelvic floor muscle strength and endurance will be evaluated with a non-invasive vaginal perineometer with digital vaginal palpation

pelvic floor power, minimum and maximum muscle contraction values

时间窗: 5 minutes

Pelvic floor power will be evaluated with intravajinal biofeedback electromyograhy(EMG)

次要结局

  • Sensory Evaluation(1 minute)
  • DETAILED STORIES OF THE PATIENTS(5 minutes)
  • Visual Analog Scale (VAS) assessment for pelvic pain(1 minute)
  • Pelvic Floor Reflex Evaluation:(1 minute)
  • Evaluation of Mistakes Made During Pelvic Floor Muscle Contraction(5 minutes)
  • Pelvic Floor Health Knowledge Test:(5 minutes)
  • Determining the severity of incontinence(1 minute)
  • Global Pelvic Floor Disorder Questionnaire(GPFDQ)(5 minutes)
  • Pelvic organ prolapse evaluation(1 minute)

研究者

发起方
Duygu Sultan Oge
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Duygu Sultan Oge

student

Hacettepe University

研究点 (1)

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