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

NCT ID: NCT06835036

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-07-31

Brief Summary

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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).

Detailed Description

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100 PwPD will receive functional exercises three times a week for three menstrual cycles. Patients will be assessed on the most painful days of the first (baseline), second, and third menstrual cycles. The receiver operating characteristics (ROC) method and Gamma coefficient analysis will be applied to determine the responsiveness.

Conditions

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Primary Dysmenorrhea Pain Menstrual Discomfort

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

In this prospective study, one treatment group was formed to receive exercise treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Treatment

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

Group Type EXPERIMENTAL

Exercise Treatment

Intervention Type 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.

Interventions

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Exercise Treatment

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Artvin Coruh University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Yıldız Kızkın

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Yıldız Kızkın, Dr.

Role: PRINCIPAL_INVESTIGATOR

Artvin Coruh University

Locations

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Zeynep Yıldız Kızkın

Artvin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26328887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35249825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1238078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22242651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10812317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28625286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15108996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36169068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34360122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32415471 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20044494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20638823 (View on PubMed)

Other Identifiers

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MCID

Identifier Type: -

Identifier Source: org_study_id

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