The Effect of Cervical Dilatation on Primary Dysmenorrhea
Primary Purpose
Dysmenorrhea Primary
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervical dilatation
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea Primary focused on measuring cervical dilatation, dysmenorrhea
Eligibility Criteria
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
Sites / Locations
- Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cervical dilatation
Expectant
Arm Description
Patients receive cervical dilatation up to 10 millimeter Hegar dilator under general anaesthesia. Patient undergo standard hysteroscopy operation.
Patients are scheduled for follow-up.
Outcomes
Primary Outcome Measures
Visual Analogue Score
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
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04682262
First Posted
December 9, 2020
Last Updated
March 18, 2021
Sponsor
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04682262
Brief Title
The Effect of Cervical Dilatation on Primary Dysmenorrhea
Official Title
The Effect of Cervical Dilatation on Pain in Nulliparous Women With Primary Dysmenorrhea.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
April 14, 2021 (Anticipated)
Study Completion Date
May 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea Primary
Keywords
cervical dilatation, dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cervical dilatation
Arm Type
Experimental
Arm Description
Patients receive cervical dilatation up to 10 millimeter Hegar dilator under general anaesthesia. Patient undergo standard hysteroscopy operation.
Arm Title
Expectant
Arm Type
No Intervention
Arm Description
Patients are scheduled for follow-up.
Intervention Type
Procedure
Intervention Name(s)
Cervical dilatation
Intervention Description
Patients undergo to cervical dilatation prior to the hysteroscopy under general anaesthesia with using Hegar dilator (no.10)
Primary Outcome Measure Information:
Title
Visual Analogue Score
Description
Patients are asked to mark their pain on a 10 point visual scale which variate between 0 (no pain) to 10 (unbearable pain).
Time Frame
Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
Title
Verbal multidimensional scoring system for assessment of dysmenorrhea severity
Description
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).
Time Frame
Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
Title
EQ-5D
Description
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).
Time Frame
Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
Other Pre-specified Outcome Measures:
Title
dyspareunia
Description
Dyspareunia is assessed by a non-validated question if she feels disturbing pain during the sexual coitus or not (present / absent).
Time Frame
Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilkhan Keskin, MD
Phone
+905344669085
Email
mdilkhankeskin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niyazi Tug, MD, Prof
Organizational Affiliation
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilkhan Keskin, MD
Phone
+905344669085
Email
mdilkhankeskin@gmail.com
First Name & Middle Initial & Last Name & Degree
Ilkhan Keskin, MD
First Name & Middle Initial & Last Name & Degree
Niyazi Tug, MD PROF
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Upon request
Citations:
PubMed Identifier
26946059
Citation
Gregersen H, Hee L, Liao D, Uldbjerg N. Distensibility and pain of the uterine cervix evaluated by novel techniques. Acta Obstet Gynecol Scand. 2016 Jul;95(7):717-23. doi: 10.1111/aogs.12891. Epub 2016 Mar 30.
Results Reference
background
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The Effect of Cervical Dilatation on Primary Dysmenorrhea
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