The Effect of Cervical Dilatation on Pain in Nulliparous Women With Primary Dysmenorrhea.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analogue Score
研究概览
简要总结
Primary dysmenorrhea (PD) is defined as recurrent, crampy pain occurring with menses in the absence of identifiable pelvic pathology. Standard initial management of PD includes NSAIDs as a first-line treatment and oral contraceptives for the relief of pain and improved daily activity. In patients who have persistent dysmenorrhea despite medical therapy of NSAIDs and/or oral contraceptives, further investigation including pelvic ultrasound, hysteroscopy or laparoscopy may be needed to rule out other underlying pathologies. Historically, It is an old clinical observation that primary dysmenorrhea is often completely or partially relieved by childbearing. Similarly, the investigators have observed that the diagnostic/operative hysteroscopy led to relive of pain in most of the cases in our practice. Therefore, the investigators hypothesized that the process of cervical dilatation can have a role in reducing pain of patients with dysmenorrhea. In this randomized, controlled study, it was aimed to assess the effect of operational cervical dilatation on the pain in patients with primary dysmenorrhea.
详细描述
Patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation) will be assessed for the presence of primary dysmenorrhea by history taking and anamnesis. Patients will be randomized to have cervical dilatation and hysteroscopy or no intervention until the follow-up duration.
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 (Investigator, Outcomes Assessor)
盲法说明
Investigator diagnosed primary dysmenorrhea with clinical history and anamnesis. Investigator refers the patient to the surgical nurse and nurse performs the randomization process and prepare the patient (control group) for the cervical dilatation and hysteroscopy and schedule the control group for follow-up (expectant). The outcomes assessor is also blind to the assigned group.
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
- •Patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation)
- •Patients whose history and anamnesis indicate primary dysmenorrhea.
- •Aged over 18 years old
- •Nulliparous women
排除标准
- •History of uterine surgery/operation
- •History and clinical examinations which are indicative of secondary dysmenorrhea (Endometriosis, Adenomyosis, Uterine myomas, Endometrial polyps, Cervical stenosis, etc.)
- •Positive pregnancy test
研究组 & 干预措施
Cervical dilatation
Patients receive cervical dilatation up to 10 millimeter Hegar dilator under general anaesthesia. Patient undergo standard hysteroscopy operation.
干预措施: Cervical dilatation (Procedure)
Expectant
Patients are scheduled for follow-up.
结局指标
主要结局
Visual Analogue Score
时间窗: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
Patients are asked to mark their pain on a 10 point visual scale which variate between 0 (no pain) to 10 (unbearable pain).
Verbal multidimensional scoring system for assessment of dysmenorrhea severity
时间窗: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
This scale assess the dysmenorrhea by grading the severity. The assessment includes working ability, systemic symptoms and the use of analgesics. The grades vary between grade 0, grade 1 (mild), grade 2 (moderate) and grade 3 (severe).
EQ-5D
时间窗: Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
The EuroQol-5D (EQ-5D) is an instrument for measuring quality of life and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
次要结局
未报告次要终点
研究者
Murat Yassa
Principal Investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital