Pain and Physical Fitness in Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Evaluation of Pain and Physical Fitness in Primary Dysmenorrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401226
• Other study ID #: KA24-1
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Bezmialem Vakif University
• Contact: Kubra Alpay, PhD
• Phone: +902124012600
• Email: kubraalpay[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Primary dysmenorrhea (PD) is a condition that occurs just before or during menstruation and is accompanied by cramp-like pain in the lower abdomen, without any pelvic pathology. Pain usually begins just before or during menstruation and ends within 12-72 hours. Most women with PD describe their menstrual pain as moderate to severe, which significantly affects their activities of daily living and school and work performance.

In PD, functions and activities of daily living are also affected due to pain and other hormonal changes. Studies have reported that musculoskeletal problems such as decreased spinal mobility, pelvic stability and postural control are observed in women with dysmenorrhea.

The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization during the menstruation and on a non-menstrual day of the cycle, in primary dysmenorrhea.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Lower extremity flexibility	Lower extremity flexibility will be performed with a sit-and-reach test. Evaluation will be carried out by measuring the distance between the platform and the hands of the subjects at the last point they can reach while reaching forward with their hands.	2 weeks
Secondary	Menstrual symptoms	Menstrual Symptom Questionnaire will be used to evaluate pain and symptoms related to menstruation. The scale score is calculated by taking the total score average of the items in the scale. An increase in the average score indicates an increase in the severity of menstrual symptoms.	2 weeks
Secondary	Depression, anxiety and stress symptoms	Depression Anxiety Stress Scale will be used. The scale consists of 3 sub-dimensions. Higher scores indicate an increase of severity of symptoms for each sub-dimensions.	2 weeks