NCT05885945

Brief Summary

Analysis of stabilometric and respiratory variables in patients with dysmenorrhea during the first day of the menstrual cycle and any other day outside the cycle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

May 23, 2023

Last Update Submit

January 26, 2024

Conditions

Dysmenorrhea Primary

Keywords

dysmenorrheadiaphragmbalancemuscular strength

Outcome Measures

Primary Outcomes (2)

  • Balance

    stabilometric variables in bipodal and monopodal support

    2 months

  • diaphragmatic muscle strength

    diaphragmatic muscle force through the maximum inspiratory pressure in the mouth

    2 months

Secondary Outcomes (1)

  • sociodemographic variables

    2 monsths

Study Arms (2)

dysmenorrhea

primary dysmenorrhea

control

control not pain

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWOMEN WITH PERIOD PAIN
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with primary dysmenorrhea

You may qualify if:

  • Adult women with primary dysmenorrhea.
  • Not having had any type of childbirth (natural, caesarean section, etc).
  • Not be positive in COVID. Antigen test in the last 24 hours or negative PCR in the last 48 hours.

You may not qualify if:

  • Receive medical treatment during research.
  • Have any orthopedic, neurological or systemic disease diagnosed other than primary dysmenorrhea.
  • Be in follow-up with any medical treatment that does not be primary dysmenorrhea
  • Women with a history of trauma or surgical treatment who involve the musculoskeletal system in the last year.
  • Use of analgesics in the last 48 hours.
  • Consumption of alcohol in the last 24 hours.
  • Have a history or suspicion of pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Catholic of Murcia

Guadalupe, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Felipe León-Morillas

    Catholic University of Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 2, 2023

Study Start

February 15, 2023

Primary Completion

June 14, 2023

Study Completion

July 31, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations

ES(1)