Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06401226

Pain and Physical Fitness in Primary Dysmenorrhea

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Alis Kostanoglu, Assoc. Prof.

SUB_INVESTIGATOR

Ayca Arslanturk, MSc

SUB_INVESTIGATOR

Kubra Alpay, PhD

CONTACT

Nilgun Gurses, Prof.

SUB_INVESTIGATOR

Sukran Sarigul, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pain assessment

    Time frame: 2 weeks

    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. Core stability

    Time frame: 2 weeks

    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.

  3. Lower extremity muscle strength

    Time frame: 2 weeks

    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.

  4. Balance

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Lower extremity flexibility

    Time frame: 2 weeks

    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. Menstrual symptoms

    Time frame: 2 weeks

    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.

  3. Depression, anxiety and stress symptoms

    Time frame: 2 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kubra Alpay, PhD

CONTACT

[email protected]

+902124012600 ext. 4638

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Evaluation of Pain and Physical Fitness in Primary Dysmenorrhea

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.