NCT06530381

Brief Summary

Pain is one of the most common symptoms of menstrual syndrome that significantly affects quality of life. The aim of our study is to compare the effect of Pilates on menstrual pain and the effectiveness of the applications within themselves.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

July 28, 2024

Last Update Submit

March 13, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    VAS is used for subjective assessment of pain. VAS scores are evaluated on a scale of 1-10. 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-8 indicates severe pain, and 9-10 indicates very severe and unbearable pain.Individuals with VAS\>5 are included in the study.

    at baseline and at week 6.

  • Short-Form 36 (SF-36)

    The SF-36 scale is used for quality of life assessment. This scale basically includes 8 subject scales. Each subject title is scored between 0-100. The scale has positive scoring, as the score increases, the quality of life also increases.

    at baseline and at week 6.

  • Menstrual Attitude Scale (MAS)

    MAS is used to evaluate symptoms in the premenstrual/menstrual period. MAS consists of 5 main topics and a total of 33 sub-items. MAS is a scale that includes both positive and negative items.

    at baseline and at week 6.

Study Arms (2)

Group 1

EXPERIMENTAL

Pilates Exercises Applied With Face-to-Face

Other: Pilates Exercises With Face-to-Face

Group 2

EXPERIMENTAL

Pilates Exercises Applied With Telerehabilitation

Other: Pilates Exercises With Telerehabilitation

Interventions

The exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period. Exercises are performed face to face.

Group 1

The exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period. Exercises are performed as telerehabilitation.

Group 2

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • People between the ages of 18-30 who have a continuing menstrual cycle.
  • Women with menstrual pain VAS\>5.
  • People with regular menstrual cycles.

You may not qualify if:

  • Being in menopause.
  • Using birth control pills.
  • Taking hormone therapy.
  • Having exercise intolerance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Unsal A, Ayranci U, Tozun M, Arslan G, Calik E. Prevalence of dysmenorrhea and its effect on quality of life among a group of female university students. Ups J Med Sci. 2010 May;115(2):138-45. doi: 10.3109/03009730903457218.

  • Daley A. The role of exercise in the treatment of menstrual disorders: the evidence. Br J Gen Pract. 2009 Apr;59(561):241-2. doi: 10.3399/bjgp09X420301. No abstract available.

  • Kirthika S V, S S, G MK, S R, Rnv D, P SS. Comparing Pilates and Gym Ball Exercises for Primary Dysmenorrhea Management: An Empirical Study. Cureus. 2024 Apr 28;16(4):e59184. doi: 10.7759/cureus.59184. eCollection 2024 Apr.

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Duygu Şahin Altaç, PT, MSc.

    Halic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc.

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

June 10, 2024

Primary Completion

July 22, 2024

Study Completion

September 10, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations