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Minimally important difference in pain and menstrual symptoms in women with menstrual colic

Minimally clinically important difference for pain and menstrial symptoms in women with primary dysmenorreia: randomized clinical test

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-894xfc
Enrollment
Unknown
Registered
2020-01-29
Start date
2019-10-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary dysmenorrhea

Interventions

Transcutaneous electrostimulation will be used in both groups, with 51 participants allocated to each group, totaling 102 volunteers. In the active group, a frequency of 100 Hz will be used, with sing
Device
E02.331
E02.331.800

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Will be included in the project nulligravous women, aged 18 to 45 years, with symptoms of primary dysmenorrhea on at least one day of the menstrual period and at least 50% of cycles, with regular menstrual cycle, pain reported as moderate or severe. (NRS >= 4).

Exclusion criteria

Exclusion criteria: Women with altered sensitivity, previous pelvic surgery, absence of symptoms in the last 2 cycles, or other associated pelvic symptoms will not be included

Design outcomes

Primary

MeasureTime frame
Pain: will be assessed using the numerical pain scale to assess the intensity of pain, applied before and after each intervention in the active TENS and TENS placebo group.;Minimally clinically important difference: assessed using the global change rating scale, applied only at the end of the intervention. Any positive score being interpreted as an improvement and any negative or null score being interpreted as a worsening of symptoms or clinical ineffectiveness of treatment.—

Secondary

MeasureTime frame
PMS symptoms: measured by the PSST questionnaire, which will be applied before and after the intervention. The questionnaire assesses symptoms in the premenstrual period such as sleep and appetite. ;quality of life: measured in SF-36, which will be applied before and after the intervention. The questionnaire is widely used to assess the quality of life of patients from different areas, it is easy to apply, it analyzes different aspects of quality of life.—

Countries

Brazil

Contacts

Public ContactPatricia Driusso

Universidade Federal de São Carlos

pdriusso@ufscar.br+55 16 3351-8111

Outcome results

None listed

Source: REBEC (via WHO ICTRP)