|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
21 December 2015 |
|
Main ID: |
NCT02372123 |
|
Date of registration:
|
20/02/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Connective Tissue Massage in Women With Primary Dysmenorrhoea
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
February 2015 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02372123 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Turkey
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Nulliparous women: aged over 18 years, diagnosis of primary dysmenorrhea according to
Primary Dysmenorrhea Consensus Guideline, having regular menstrual cycles, a history
of menstrual pain starting in the first few years after menarche and menstrual pain
rated higher than 40 mm on a visual analog scale considering the last six months
Exclusion Criteria:
- Menstrual pain below 40 mm on the VAS
- Severe gastrointestinal, urogynecological or autoimmune disease
- other chronic pain syndromes
- psychiatric disorder
- childbirth
- positive pregnancy test
- intrauterine device
- urogynecologic surgery
- chronic medication including oral contraceptives or antidepressants for at least six
months prior to study
- irregular menstrual cycles
- a history or ultrasonographic observation of pathologic conditions
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Pelvic Pain
|
|
Dysmenorrhea
|
|
Intervention(s)
|
|
Other: connective tissue manipulation
|
|
Other: lifestyle advice
|
|
Primary Outcome(s)
|
|
menstrual pain intensity
[Time Frame: one month]
|
|
Secondary Outcome(s)
|
|
Menstrual Attitude Score
[Time Frame: one month]
|
|
Menstrual Pain Catastrophizing Score
[Time Frame: one month]
|
|
Menstrual Symptom Score
[Time Frame: one month]
|
|
Number of pain medication
[Time Frame: one month]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|