More Than Just p-Values: MCID for the VAS, MSQ and FEMD in Patients With Primary Dysmenorrhea

NCT06835036 | Completed

• 1 other identifier: MCID
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD).

Conditions

Primary Dysmenorrhea; Pain; Menstrual Discomfort

Keywords

Dysmenorrhea; Menstruation; Visual Analog Scale; Minimal Clinically Important Difference; ROC Curve

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).

  Baseline (On the most painful day of the menstrual cycle before the intervention)

• Pain Intensity

  Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).

  After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)

• Pain Intensity

  Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).

  After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)

Secondary Outcomes (8)

• Menstrual Symptom Questionnaire (MSQ)

  Baseline (On the most painful day of the menstrual cycle before the intervention)

• Menstrual Symptom Questionnaire (MSQ)

  After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)

• Menstrual Symptom Questionnaire (MSQ)

  After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)

• Functional and Emotional Measure of Dysmenorrhea (FEMD)

  Baseline (On the most painful day of the menstrual cycle before the intervention)

• Functional and Emotional Measure of Dysmenorrhea (FEMD)

  After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)

Study Arms (1)

Exercise Treatment

EXPERIMENTAL

Each patient will receive a treatment protocol consisting of warm-up and functional exercises.

Other: Exercise Treatment

Interventions

Exercise Treatment OTHER

In this study, a functional exercise programme will be performed 3 days a week for 8 weeks in three cycles as previously recommended. This programme consisted of a 5-minute warm-up and a 45-minute exercise phase.

Exercise Treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Only women with primary dysmenorrhea will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of PD according to the "No. 345-Primary Dysmenorrhea Consensus Guideline",
• Pain level of three or more according to VAS during activity (moderate to severe pain),
• Patients aged 18-35 years (when PD becomes more prevalent),
• Regular menstrual cycle with a duration of 28±7 days,
• Nulliparity.

You may not qualify if:

• Historical background of chronic urogenital infections or drug use,
• Pregnancy,
• Secondary dysmenorrhoea caused by gynaecological conditions such as endometriosis, adenomyosis and uterine fibroids.

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Zeynep Yıldız Kızkın

Artvin, 08000, Turkey (Türkiye)

Location

Related Publications (12)

• Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29.

  PMID: 26328887 BACKGROUND

• Guy M, Foucher C, Juhel C, Rigaudier F, Mayeux G, Levesque A. Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo. Prog Urol. 2022 Jul;32(7):487-497. doi: 10.1016/j.purol.2022.01.005. Epub 2022 Mar 3.

  PMID: 35249825 BACKGROUND

• Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available.

  PMID: 1238078 BACKGROUND

• Li L, Huangfu L, Chai H, He W, Song H, Zou X, Wang W. Development of a functional and emotional measure of dysmenorrhea (FEMD) in Chinese university women. Health Care Women Int. 2012;33(2):97-108. doi: 10.1080/07399332.2011.603863.

  PMID: 22242651 BACKGROUND

• Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1.

  PMID: 10812317 BACKGROUND

• Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.

  PMID: 28625286 BACKGROUND

• Myles PS. The pain visual analog scale: linear or nonlinear? Anesthesiology. 2004 Mar;100(3):744; author reply 745. doi: 10.1097/00000542-200403000-00042. No abstract available.

  PMID: 15108996 BACKGROUND

• Yahaya Y, Ismail AH, Shamsuddin NH. Primary dysmenorrhoea among reproductive-age women at Kuala Selangor health clinic: Prevalence and factors associated. Med J Malaysia. 2022 Sep;77(5):569-575.

  PMID: 36169068 BACKGROUND

• Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.

  PMID: 34360122 BACKGROUND

• Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.

  PMID: 32415471 BACKGROUND

• Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31.

  PMID: 20044494 BACKGROUND

• Lehman LA, Velozo CA. Ability to detect change in patient function: responsiveness designs and methods of calculation. J Hand Ther. 2010 Oct-Dec;23(4):361-70; quiz 371. doi: 10.1016/j.jht.2010.05.003. Epub 2010 Jul 17.

  PMID: 20638823 BACKGROUND

MeSH Terms

Conditions

Pain; Dysmenorrhea

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Pelvic Pain

Study Officials

• Zeynep Yıldız Kızkın, Dr.

  Artvin Coruh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: In this prospective study, one treatment group was formed to receive exercise treatment.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 19, 2025
• Study Start: February 15, 2025
• Primary Completion: July 3, 2025
• Study Completion: July 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)