Dysmenorrhea Primary
Conditions
Keywords
cervical dilatation, dysmenorrhea
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECervical dilatation
Patients undergo to cervical dilatation prior to the hysteroscopy under general anaesthesia with using Hegar dilator (no.10)
Sponsors
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Score | 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 | 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 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| dyspareunia | Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month | Dyspareunia is assessed by a non-validated question if she feels disturbing pain during the sexual coitus or not (present / absent). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactIlkhan Keskin, MD
Outcome results
None listed