Pain and Physical Fitness in Primary Dysmenorrhea

NCT06401226 | Recruiting

• 1 other identifier: KA24-1
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in primary dysmenorrhea.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (4)

• Pain assessment

  Pain assessment will be evaluated with a visual analog scale. Subjects will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means very severe pain.

  2 weeks

• Core stability

  A pressurized biofeedback device will be used to evaluate core stability. The device will initially be set to 70 mmHg pressure and changes in pressure will be recorded for analysis at the end of the evaluation.

  2 weeks

• Lower extremity muscle strength

  A 30-second sit to stand test will be used to evaluate the individual's lower extremity muscle strength and functional capacity. The number of repetitions performed in 30 seconds is recorded.

  2 weeks

• Balance

  Biodex Balance System (Biodex Medical Systems, Inc. USA) will be used in the dynamic postural stability test and sensory integration of balance clinical test evaluations.

  2 weeks

Secondary Outcomes (3)

• Lower extremity flexibility

  2 weeks

• Menstrual symptoms

  2 weeks

• Depression, anxiety and stress symptoms

  2 weeks

Study Arms (2)

Primary Dysmenorrhea

Women with primary dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide and those with pain \> 5 according to visual analog scale

Control Group

Women who do not experience painful cramps during their menstrual period or who have a visual analog scale score \< 5

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The primary dysmenorrhea group will consist of cases diagnosed by a gynecologist. The Control Group will consist of healthy women who meet inclusion criteria.

You may qualify if:

• Between the ages of 18-25
• Body mass index of 18-25 kg/m2
• Having a regular menstrual cycle (28±7 days)
• For the PD Group; pain level \>5 according to VAS during menstruation
• For the Control Group; having a VAS score of 5 or less

You may not qualify if:

• Having given birth before
• Using an intrauterine device
• Having a health problem that causes chronic pain
• Having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder
• Being diagnosed with a gynecological or pelvic disorder such as endometriosis, ovarian cyst
• Having a history of abdominal or gynecological surgery within the last year
• Being on oral contraceptive use/hormonal therapy or antidepressant treatment
• Having used painkillers 12 hours before the evaluation
• Participating in a regular exercise program

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• Kubra Alpay

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kubra Alpay, PhD

CONTACT

+902124012600; kubraalpay@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: May 6, 2024
• Study Start: June 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

TU (1)